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Hand and Wrist Guideline With Addendum 2022

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50 views162 pages

Hand and Wrist Guideline With Addendum 2022

Uploaded by

Monica Lui
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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Hand and wrist orthoses

for adults with rheumatological conditions


Practice guideline for occupational therapists
Second Edition

Royal College of Occupational Therapists


Front cover photograph ©iStockphoto.com

Other RCOT practice guidelines available:


Occupational therapists’ use of occupation-focused practice in
secure hospitals

Occupational therapy for adults undergoing total hip replacement

Occupational therapy in neonatal services and early intervention

Occupational therapy in the prevention and management of falls in adults

For further details, more publications and free downloads please visit
www.rcot.co.uk/publications

About the publisher

The Royal College of Occupational Therapists is a wholly


owned subsidiary of the British Association of Occupational
Therapists (BAOT) and operates as a registered charity. It
represents the profession nationally and internationally,
and contributes widely to policy consultations throughout
the UK. RCOT sets the professional and educational
standards for occupational therapy, providing leadership,
guidance and information relating to research
and development, education, practice
and lifelong learning. In addition,
10 accredited specialist sections
support expert clinical practice.

rcot.co.uk

Version 2/2022
Hand and wrist orthoses
for adults with rheumatological
conditions
Practice guideline for occupational therapists
Second Edition

Royal College of Occupational Therapists

This publication is endorsed by


This 2nd edition published in 2020
by the Royal College of Occupational Therapists Ltd
106–114 Borough High Street
London SE1 1LB
www.rcot.co.uk

Addendum published October 2022 to include new evidence.

Copyright © Royal College of Occupational Therapists 2020

Author: Royal College of Occupational Therapists


Editors: Dr Gillian Ward, Angie Thompson and Ruth Squire
2nd Edition Guideline Development Review Group: Patricia Bisset, Elizabeth Doherty, Kerry
Edwards, Joanna Harness, Laura Ingham, Katharine Noel, Ebby Sigmund, Ruth Squire
Category: Practice Guidelines
Date for Review: 2025

Original Guideline Development Group (2015): Jo Adams, Cathy Ball, Lucy Blenkiron, Sarah
Bradley, Katie McAlarey, Lucia Ramsey, Ruth Squire

All rights reserved, including translation. No part of this publication may be reproduced, stored in
a retrieval system or transmitted, by any form or means, electronic, mechanical, photocopying,
recording, scanning or otherwise, without the prior permission in writing of the Royal College of
Occupational Therapists, unless otherwise agreed or indicated. Copying is not permitted except
for personal and internal use, to the extent permitted by national copyright law, or under the
terms of a licence issued by the relevant national reproduction rights organisation (such as the
Copyright Licensing Agency in the UK). Requests for permission for other kinds of copying, such
as copying for general distribution, for advertising or promotional purposes, for creating new
collective works, or for resale, should be addressed to the Publications Manager at the above
address.

Other enquiries about this document should be addressed to the Royal College of Occupational
Therapists Specialist Section – Trauma and Musculoskeletal Health at the above address.

British Library Cataloguing in Publication Data


A catalogue record for this book is available from the British Library.

While every effort has been made to ensure accuracy, the Royal College of Occupational
Therapists shall not be liable for any loss or damage either directly or indirectly resulting from
the use of this publication.

ISBN 978-1-913496-01-2

The following are recognised as trademarks: B&L Engineering Pinch Gauge, Comfort Cool, Futuro,
Grippit, Jamar, Oval-8, Plastazote, Preston Pinch Gauge, Rhizo-Hit, Rhizomed, Rolyan, Velcro,
X-LITE.

Typeset by Servis Filmsetting Ltd, Stockport, Cheshire


Contents

2nd edition forewords v

Key recommendations for implementation 1

1 Introduction 5
1.1 Practice requirement for the guideline 5
1.2 Topic identification process 6
1.3 National context 6
1.4 Context of service delivery 7
1.5 Background to clinical conditions 8

2 The occupational therapy role 10

3 Objective of the guideline 14

4 Guideline scope 16
4.1 Clinical questions 16
4.2 Target population 17
4.3 Target audience 18

5 Recommendations and supporting evidence 20


5.1 Rheumatoid arthritis: orthoses for activity and rest 21
5.2 Osteoarthritis: base of thumb orthoses 27
5.3 Optimising outcomes of people who access services 33
5.4 Potential impact of the recommendations 41

6 Perspectives of people who accessed services 44

7 Implementation of the guideline 47


7.1 Dissemination and promotion 47
7.2 Organisational and financial barriers 47
7.3 Implementation resources 49

8 Recommendations for future research 51

9 Guideline development process – 1st edition 53


9.1 Guideline development group 53
9.2 Stakeholder involvement 53

NICE has accredited the process used by the Royal College of Occupational Therapists to
produce its practice guidelines. Accreditation is valid for five years from January 2018 and
is applicable to guidance produced using the processes described in the Practice guideline
development manual 4th edition (2020). More information on accreditation can be viewed at
www.nice.org.uk/accreditation.

Royal College of Occupational Therapists 2020


­iii
Contents

9.3 Involvement of people who access services 54


9.4 Occupational therapists’ consultation 55
9.5 External peer review 56
9.6 Conflicts of interest 56
9.7 Declaration of funding for the guideline development 57
9.8 Royal College of Occupational Therapists’ appraisal and ratification process 57

10 Guideline methodology 58
10.1 Guideline questions 58
10.2 Literature search strategy and outcomes 59
10.3 Criteria for inclusion and exclusion of evidence 60
10.4 Strengths and limitations of body of evidence 61
10.5 Method used to arrive at recommendations 63

11 Guideline review process – 2nd edition 65


11.1 Guideline review group established 65
11.2 Identification of new evidence 65
11.3 Assessment of update requirements 67
11.4 External review 67
11.5 College appraisal and ratification process 67
11.6 Overview of limitations and any potential bias of the guideline 68

12 Updating the guideline 72

Appendix 1: Guideline development and review groups 73


Appendix 2: Acknowledgements 76
Appendix 3: Conflicts of interest declarations 79
Appendix 4: Literature search strategy (1st edition) 80
Appendix 5: Literature search strategy (2nd edition) 83
Appendix 6: Evidence tables 88
Appendix 7: Outline of other evidence for orthoses 132
Appendix 8: Glossary and abbreviations 134
References140

Addendum October 2022

This guideline was developed using the processes defined within the Practice guideline
development manual (Royal College of Occupational Therapists [RCOT] 2020).
Readers are referred to the manual to obtain further details of specific stages within the
guideline development process.
The manual is available at: https://www.rcot.co.uk/node/293

­iv Hand and wrist orthoses for adults with rheumatological conditions
2nd edition forewords

Effective self-management, in conjunction with collaborative multidisciplinary team


management in rheumatoid arthritis and osteoarthritis, requires clients to make
multiple changes and teams to provide multiple interventions. To maximise effective
service delivery, these must be evidence-based. The Royal College of Occupational
Therapists Specialist Section – Trauma and Musculoskeletal Health is to be commended
for the detailed work into further developing this Hand and wrist orthoses practice
guideline – second edition.

Hand and wrist orthoses are still core interventions provided to many people with
arthritis, to reduce hand symptoms and improve hand function, alongside hand
exercises and joint protection. This guideline continues to be an impressive, well-
referenced contribution to musculoskeletal occupational therapy. Clear evidence-based
recommendations for standardised assessment, which can be readily integrated into
practice, are also given. The guideline is exemplary, with the method and article reviews
thoroughly explained, following accredited review processes. It is an authoritative
guideline, which occupational therapists and clients with arthritis can use with
confidence. The authors are to be congratulated on their commitment to our specialty
and profession.

The authors highlight the limitations of the current research available, such as limited
evidence for long-term effectiveness, cost-effectiveness, and for certain orthoses.
Further trials are still needed, including mixed methods to obtain user perspectives and
cost-effectiveness outcomes. The authors identify research questions that offer many
research opportunities in future.

The developers understand that creating guidelines does not always mean they can be
implemented. They highlight potential barriers in changing practice and have created
continuing professional development and audit tools, and recommended strategies to
enable implementation. As musculoskeletal occupational therapists, it is now our
responsibility to ensure the guideline is understood and implemented into practice.

Alison Hammond PhD, FCOT


Professor in Rheumatology Rehabilitation

Long-term rheumatic and musculoskeletal diseases can have a dramatic impact on a


person’s quality of life. While pharmacological therapy can alter disease processes and
reduce pain, optimal management requires input from multiple professionals with
access to a range of pharmacological and non-pharmacological therapies. Indeed,
access to the wider multidisciplinary team, specifically occupational therapy, is
recommended by both NICE (2018) and SIGN (2011). Hand involvement is almost
ubiquitous in rheumatoid arthritis and, although patients value occupational therapy,
only 40% of patients access such services (National Audit Office 2009).

Clearly there is still much to do before all patients can receive the care they require, but
this guideline will play an important role in achieving this goal. The authors should be
congratulated on the substantial work conducted to produce this robust and pragmatic

Royal College of Occupational Therapists 2020


­v
2nd edition forewords

guideline. Similarly, the College and wider profession should also be acknowledged for
obtaining accreditation to produce NICE-endorsed guidelines, and for developing the
evidence base to inform the specific recommendations within.

I sincerely hope that this guideline is used to improve individual patient care, and that it
is used on a wider level to increase the provision of this much-needed service.

Dr Caroline Flurey
Vice President of British Society for Rheumatology and
Chair of British Health Professionals in Rheumatology

­vi Hand and wrist orthoses for adults with rheumatological conditions
Key recommendations for
implementation

Update 2022: new research on the clinical and cost-effectiveness of compression gloves
published after a review of this guideline has necessitated an amendment to the 2020
edition (see addendum).

The aim of this practice guideline is to provide specific evidence-based


recommendations that describe the most appropriate care or action to be taken by
occupational therapists working with adults who may benefit from a hand or wrist
orthosis as an intervention for a rheumatological condition. It is intended for use in all
four nations of the United Kingdom. Physiotherapists, hand therapists, orthotists,
nurses and others who prescribe or use orthoses may also wish to refer to the guideline
to inform their practice.

An orthotic intervention prescribed by an occupational therapist is usually one


component of a more comprehensive joint protection and self-management
programme (Hammond 2014). The recommendations are intended to be used
alongside the therapist’s clinical expertise in their assessment of need and
implementation of interventions. The practitioner, therefore, is ultimately responsible
for the interpretation of this evidence-based guideline in the context of their specific
circumstances and each individual’s needs.

Recommendation statements should not be taken in isolation and must be considered


in conjunction with the contextual information provided in this document, together with
the details on the strength and quality of the recommendations. The statements are
graded based on the Grading of Recommendations Assessment, Development and
Evaluation (GRADE) process (GRADE Working Group 2004), as described in the Royal
College of Occupational Therapists’ Practice guideline development manual (RCOT 2020).
The strength of the recommendations is identified via a scoring of 1 (strong) or 2
(conditional), and the quality of the supporting evidence via a grading on a scale of A
(high) to D (very low). This revised edition of the guideline strengthens the previous
recommendations. It is strongly advised that readers study Sections 10 and 11 to
understand the guideline methodology, together with the evidence tables in Appendix
6, to be fully aware of the outcome of the literature searches and overall available
evidence.

The guideline aims to support the occupational therapist’s decision-making and clinical
reasoning and, being based on evidence, cannot cover all aspects of occupational
therapy practice with respect to the prescription of orthoses for rheumatological
conditions. It is also not intended to be a guide on assessment or orthosis fabrication.

The evidence includes research published since 2004, and participants with rheumatoid
arthritis recruited to some of these studies may not have had access to current
biological therapies. While only people with more aggressive forms of the disease will
meet the eligibility criteria to receive such medication, the improved outcomes that have
been reported may have influenced the findings of more recent studies. More dated
research may not, therefore, necessarily be representative of the current population
living with rheumatoid arthritis.

Royal College of Occupational Therapists 2020


­1
Key recommendations for implementation

The recommendations, based on the best available evidence to date, are set out in three
categories:

1. Rheumatoid arthritis: orthoses for activity and rest.


2. Osteoarthritis: base of thumb orthoses.
3. Optimising outcomes for people who access services.

Recommendations could not be developed, due to insufficient evidence, for a number of


presentations of rheumatoid arthritis (e.g. ulnar deviation, Boutonnière deformity);
trigger finger; carpal tunnel syndrome (CTS) (where there is an underlying inflammatory
pathology); the use of compression gloves; or for conditions such as psoriatic arthritis or
systematic lupus erythematosus. Orthoses may, however, be prescribed for these other
inflammatory conditions, and the absence of published evidence does not mean that an
orthotic intervention may not be effective for those people.

It is important to highlight that this guideline is based on the best available evidence to
date and subsequently the recommendations cannot explicitly address all clinical, health
and social care areas or outcomes identified within the scope. The guideline therefore
does not reflect the full range of orthotic interventions used in practice by occupational
therapists. While the recommendations for rheumatoid arthritis and osteoarthritis
cannot be extrapolated to other inflammatory conditions, the recommendations for
optimising outcomes for people who access services provide overarching principles that
can be considered as part of the prescription of any hand or wrist orthosis for adults with
rheumatological conditions.

Recommendations by category
The recommendations are not presented in any order of priority or relative importance.
The overall quality of evidence grade reflects the robustness or type of research
supporting a recommendation, but not necessarily the recommendation’s significance to
occupational therapy practice.

‘It is recommended. . .’ benefits appear to outweigh the risks (or vice versa) for the
majority of the target group; most people would want or should receive this course of
intervention or action.

‘It is suggested. . . .’ risks and benefits are more closely balanced, or there is more
uncertainty in likely values and preferences of people who access services; the majority
of people would want this intervention, but not all, and therefore they should be
supported to arrive at a decision for intervention consistent with the benefits and their
values and preferences.

Rheumatoid arthritis: orthoses for activity and rest


Functional wrist orthoses
1. It is recommended that a functional wrist orthosis should be prescribed 1A
for people experiencing wrist pain as a result of rheumatoid arthritis.
(Ramsey et al 2014 [A]; Thiele et al 2009 [C]; Veehof et al 2008a [B]; Pagnotta
et al 2005 [C]; Haskett et al 2004 [B])

­2 Hand and wrist orthoses for adults with rheumatological conditions


Key recommendations for implementation

Resting/night orthoses
2. It is suggested that where a night or resting orthosis is being considered 2B
as potentially beneficial to reduce symptoms for a person with
rheumatoid arthritis, both subjective and objective measures are used for
the monitoring and review of effectiveness.
(Adams et al 2008 [B]; Silva et al 2008 [A])
Orthoses for swan neck deformity
3. It is suggested, when considering an orthosis for swan neck deformity, 2C
that a potential positive effect on dexterity should be balanced by
possible adverse effects such as pressure and paraesthesia.
(Giesen et al 2010 [D]; Giesen et al 2009 [C]; Spicka et al 2009 [D]; Zijlstra et al
2004 [C])

Osteoarthritis: base of thumb orthoses


Orthoses to reduce pain and/or improve function
4. It is recommended that an orthosis should be prescribed for people 1A
experiencing pain and/or functional difficulties with activities of daily living
as a result of thumb base osteoarthritis.
(Cantero-Téllez et al 2018 [B]; Vegt et al 2017 [B]; Bani et al 2014 [C]; Hamann
et al 2014 [D]; Hermann et al 2014 [B]; Maddali-Bongi et al 2014 [C]; Bani et al
2013a [C]; Bani et al 2013b [A]; Becker et al 2013 [B]; Kjeken et al 2011a [A];
Kjeken et al 2011b [A]; Sillem et al 2011 [B]; Gomes Carreira et al 2010 [B];
Boustedt et al 2009 [C]; Moe et al 2009 [A]; Rannou et al 2009 [A]; Egan and
Brousseau 2007 [B]; Wajon and Ada 2005 [A]; Weiss et al 2004 [C])
[New evidence 2020]
Orthoses to improve grip and pinch strength
5. It is suggested that an orthosis can improve the grip/pinch strength for 2C
some people with thumb base osteoarthritis.
(Bani et al 2014 [C]; Hermann et al 2014 [B]; Maddali-Bongi et al 2014 [C];
Bani et al 2013a [C]; Bani et al 2013b [A]; Becker et al 2013 [B]; Sillem et al
2011 [B]; Wajon and Ada 2005 [A]; Weiss et al 2004 [C])

Royal College of Occupational Therapists 2020


­3
Key recommendations for implementation

Optimising outcomes for people accessing services


6. It is recommended that validated, standardised assessment and outcome 1A
measures are used pre- and post-provision of an orthosis to monitor
progress and evaluate effectiveness. Measures may include assessing
functional outcomes, understanding individual satisfaction and utilising
Patient Reported Experience Measures (PREMs).
(Duong et al 2018 [D]; Healy et al 2018 [B]; Aebischer et al 2016 [B]; Hammond
et al 2016 [C]; Bertozzi et al 2015 [B]; Bani et al 2014 [C]; Hermann et al 2014
[B]; Maddali-Bongi et al 2014 [C]; Nasir et al 2014 [C]; Bani et al 2013a [C]; Bani
et al 2013b [A]; Kjeken et al 2011a [A]; Sillem et al 2011 [B]; Gomes Carreira et
al 2010 [B]; Boustedt et al 2009 [C]; Giesen et al 2009 [C]; Rannou et al 2009 [A];
Boer et al 2008 [C]; Silva et al 2008 [A]; Veehof et al 2008a [B]; Pagnotta et al
2005 [C]; Wajon and Ada 2005 [A]; Haskett et al 2004 [B]; Weiss et al 2004 [C];
Zijlstra et al 2004 [C])
[Statement amended and new evidence 2020]
7. It is suggested that, given the inconsistent evidence of a superior orthosis 2A
fabrication/design or wearing regimen, the orthosis selected should
maximise occupational performance and individual choice.
(Cantero-Téllez et al 2018 [B]; Almeida et al 2017 [B]; Vegt et al 2017 [B];
Bertozzi et al 2015 [B]; Spaans et al 2015 [B]; Nasir et al 2014 [C]; Bani et al
2013b [A]; Becker et al 2013 [B]; Sillem et al 2011 [B]; Giesen et al 2009 [C];
Thiele et al 2009 [C]; Wajon and Ada 2005 [A]; Haskett et al 2004 [B]; Weiss et
al 2004 [C])
[New evidence 2020]
8. It is recommended that to optimise adherence to wearing a prescribed 1C
orthosis, the occupational therapist should discuss with the person the
potential benefits and limitations; practicalities of use and comfort;
provide the opportunity to try on orthoses prior to issue; and routinely
arrange follow-up review of the intervention.
(Tada et al 2018 [D]; Almeida et al 2017 [B]; Shankland et al 2017 [C]; Nasir et
al 2014 [C]; Boer et al 2008 [C]; Gooberman-Hill et al 2013 [D]; Veehof et al
2008b [C]; Pagnotta et al 2005 [C]; McKee and Rivard 2004 [D])
[New evidence 2020]

It is additionally recommended that occupational therapists use the audit tool that is
available to support this guideline (see Section 7) to undertake audit against the above
recommendations.

Update 2022: new research on the clinical and cost-effectiveness of compression gloves
published after a review of this guideline has necessitated an amendment to the 2020
edition (see addendum).

­4 Hand and wrist orthoses for adults with rheumatological conditions


1 Introduction

Pain and disability are a key focus for the management of rheumatological conditions.
Arthritis Research UK states in its parliamentary guide to musculoskeletal conditions
that ‘untreated arthritis, regardless of the cause, can lead to pain, disability and lost
quality of life’ (Arthritis Research UK 2012, p4). Pain experienced as a result of
musculoskeletal conditions can have a significant impact on an individual’s ability to
participate in daily life (Public Health England 2019).

The rheumatological conditions covered by this guideline are considered to be long-


term conditions with impact on the individual and on the health and social care systems.
Versus Arthritis reports that treating the most common forms of arthritis – osteoarthritis
and rheumatoid arthritis – cost the NHS and wider healthcare system £10.2 billion in
direct costs in 2017 (York Health Economics 2017, cited in Versus Arthritis 2019a, p17).
The organisation also estimates that lost working days due to osteoarthritis and
rheumatoid arthritis cost the UK economy £2.58 billion in 2017 (York Health Economics
2017, cited in Versus Arthritis 2019a, p17).

This review of the practice guideline focuses on the contribution that orthotic
interventions can make to the health and wellbeing of individuals with rheumatological
conditions.

1.1 Practice requirement for the guideline


Occupational therapy is a key intervention for individuals who have a rheumatological
condition, especially when there is wrist and hand involvement. Pain in these areas often
has an impact on an individual’s occupational performance. Interventions provided by
occupational therapists working in rheumatology, therefore, commonly include the
consideration of wrist and hand-based orthoses.

The College of Occupational Therapists Specialist Section – Rheumatology (COTSS –


Rheumatology)*, formerly called the National Association of Rheumatology Occupational
Therapists (NAROT), developed a series of clinical guidelines in 2003, including one on
splinting (NAROT 2003a). These guidelines aimed to support occupational therapy staff
to deliver evidence-based practice. The clinical guidelines were accessed, used and
valued by practitioners, indicative of a continuing need for information to support
evidence-informed best practice. The guidelines, of which Splinting was the most
frequently downloaded in the series, were withdrawn in 2013.

In 2007, COTSS – Rheumatology* carried out a membership survey to identify the main
research priorities among practitioners (McArthur 2007a). Results showed that research
evidence for the use of orthoses was the second most requested area for clinicians, and
hand therapy was third for people who accessed services, with pain relief at the top of
the priority list (McArthur 2007b).

* The development and publication of the 1st edition of the practice guideline was funded by the College of Occupational
Therapists and the COT Specialist Section – Rheumatology (now part of the RCOT Specialist Section – Trauma and
Musculoskeletal Health).

Royal College of Occupational Therapists 2020


­5
Introduction

Recognising that the original guidelines published by NAROT (2003b) were dated, the
Specialist Section’s National Executive Committee made a commitment to support the
development of more specific and targeted practice guidelines produced in line with the
Royal College of Occupational Therapists’ NICE-accredited process (RCOT 2020).

1.2 Topic identification process


COT SS – Rheumatology identified from the literature, and from discussions taking place
within their study days and conferences, a wide variation in the prescription of hand
orthoses within rheumatology occupational therapy practice (Doherty et al 2009). Hand
and wrist orthoses for rheumatological conditions were identified as the topic for this
occupational therapy practice guideline. Specialist Section members were alerted to the
proposal via the Section’s newsletter.

A guideline project proposal was developed by COTSS – Rheumatology* and this was
subsequently approved by the College of Occupational Therapists’ Publications Group in
November 2013.

1.3 National context


‘Musculoskeletal conditions’ is an umbrella term for a range of conditions, including
inflammatory conditions such as rheumatoid arthritis, conditions that cause
musculoskeletal pain, such as osteoarthritis, and osteoporosis and fragility fractures
(Versus Arthritis 2019a). This guideline focuses on rheumatoid arthritis and
osteoarthritis.

Rheumatology involves the investigation, diagnosis and management of conditions that


include inflammatory arthropathies (for example, rheumatoid arthritis); degenerative
arthropathies (for example, osteoarthritis); systemic conditions and connective tissue
disease; and soft tissue rheumatism (British Society for Rheumatology 2019).

Over 5 million people in the UK have arthritis of the hand. Osteoarthritis is the most
common form, with rheumatoid arthritis the next most common (Versus Arthritis 2013).

Osteoarthritis is normally associated with later life. Data collected by the Arthritis
Research UK Primary Care Centre at Keele University identified the prevalence of
consultation, with a general practitioner, for osteoarthritis in those aged 45 years or over
in the UK as 33%. Hand and wrist consultation prevalence is estimated at 6%,
representing 1.56 million people. Women aged 45–64 years are more than twice as likely
as men in that age group to have consulted their general practitioner regarding hand or
wrist osteoarthritis – an estimated 620,000 women in the UK (Arthritis Research UK
2013, p31).

Rheumatoid arthritis is the second most common form of arthritis, and can affect adults
of any age, although 40–60 years of age is the most common for rheumatoid arthritis to
develop (Scott and Bosworth 2014). The Global Burden of Disease Study estimated that
over 460,000 UK adults had rheumatoid arthritis in 2017 (Institute for Health Metrics and
Evaluation 2019). Rheumatoid arthritis is the most common inflammatory arthritis, with
prevalence being 2–3 times greater in women than in men (Versus Arthritis 2019a).

* The development and publication of the 1st edition of the practice guideline was funded by the College of Occupational
Therapists and the COT Specialist Section – Rheumatology (now part of the RCOT Specialist Section – Trauma and
Musculoskeletal Health).

­6 Hand and wrist orthoses for adults with rheumatological conditions


Introduction

1.4 Context of service delivery


The UK population is ageing. The number of people aged 65 or over is growing faster
than the number of people under 65 in the UK. The number of people aged 65–85 rose
by 23% to 10.6 million between 2008 and 2018. The number of people aged over 85
increased by 22.8% to 1.6 million in the same period (Office for National Statistics 2018).
Looking ahead, it is predicted that in the next 20 years in England alone there will be an
increase of around 49% in the 65 and older age group, to around 4.75 million people.
The fastest growing age group is those aged over 85, where the expected increase is
almost 114%, or 2.8 million people (Age UK 2017).

The impact of arthritis on individuals can be significant; it is estimated that one-third of


the population over 50 have some form of arthritis that is troublesome enough to
interfere with everyday activities.

Service delivery must, therefore, be seen in the context of the prevalence of


osteoarthritis and rheumatoid arthritis, a rising older population, an increase in those
with long-term or multiple conditions, and the associated increase in need for care and
support (Great Britain. Parliament Select Committee on Public Service and Demographic
Change 2013).

The National Institute for Health and Care Excellence (NICE) defines several clinical
pathways, one of which is for musculoskeletal conditions. The musculoskeletal pathway
identifies a number of sub-pathways, including pathways for both rheumatoid arthritis
(NICE 2018) and osteoarthritis (NICE 2014a).

The commissioning and delivery of services in England and Wales is expected to


consider the clinical guideline (NICE 2014b) for osteoarthritis and the clinical guideline
(NICE 2018) and quality standard (NICE 2013) for rheumatoid arthritis. In Scotland, there
is a clinical guideline for the management of early rheumatoid arthritis (SIGN 2011).

The NICE guideline for the care and management of osteoarthritis identifies both
pharmacological and non-pharmacological management and treatment options (NICE
2014b). A key recommendation refers to holistic assessment and management. This states:

Assess the effect of osteoarthritis on the person’s function, quality of life, occupation,
mood, relationships and leisure activities. [Recommendation 1.2.1] (NICE 2014b, p10)

NICE recommendations that refer to the need to agree an individualised plan that
considers factors such as comorbidities, and risks and benefits of treatment options, are
also pertinent to this guideline.

The rheumatoid arthritis clinical guideline (NICE 2018) highlights the importance of the
multidisciplinary team, with a recommendation that:

Adults with rheumatoid arthritis should have ongoing access to a multidisciplinary team.
This should provide the opportunity for periodic assessments of the effect of the disease
on their lives (such as pain, fatigue, everyday activities, mobility, ability to work or take
part in social or leisure activities, quality of life, mood, impact on sexual relationships)
and help to manage the condition. [Recommendation 1.7.1] (NICE 2018, p10–11)

Royal College of Occupational Therapists 2020


­7
Introduction

Adults with rheumatoid arthritis should have access to specialist occupational therapy
with periodic review if they have:

• difficulty with any of their everyday activities or


• problems with hand function. [Recommendation 1.8.2] (NICE 2018, p11)

The recognition of the contribution of different members of the multidisciplinary team in


the provision of rheumatology services is essential. Orthoses, for example, may be
prescribed by occupational therapists, physiotherapists, orthotists or hand therapists,
and the health professional(s) involved will reflect local service delivery pathways.

Many occupational therapy services across the country continue to receive large
numbers of referrals per year and a significant proportion is for splinting interventions
(Benharoch 2013, Tougher 2013). Splinting remains a core intervention offered to people
with arthritis and aligns well with joint protection education. The challenge for
occupational therapy researchers is to produce substantive evidence on the efficacy (or
how well the intervention works in ideal settings) and effectiveness of splint provision:
for example, future research questions should focus on which splint designs are the
most effective and at which stage of the disease process splints should be considered
(Adams 2010, Ekelman et al 2014). With this issue in mind, occupational therapists will
want to note findings from contemporary research on compression gloves that indicates
they are no more effective than loose-fitting gloves and not cost-effective (Hammond et
al 2018a). An abstract of this research was published; however, this is not at the
strongest evidence level to support practice decisions or influence the guideline
recommendations, but occupational therapists can review the full article when
published (due 2020).

Update 2022: The publication of the Hammond et al article has necessitated an


addendum to this guideline (see addendum).

1.5 Background to clinical conditions


The recommendations within this guideline focus on osteoarthritis and rheumatoid
arthritis. This reflects findings from the literature search for evidence that support the
use of hand and wrist orthoses for adults with rheumatological conditions. A brief
outline of these two particular conditions is therefore provided.

1.5.1 Osteoarthritis
A range of factors is understood to increase the risk of osteoarthritis, and it may develop
because of a combination of factors, such as damage to the joints (excessive loading, i.e.
stress over time); injury or disease; occupation; joint abnormalities and genetic factors
(Versus Arthritis 2019a).

Osteoarthritis develops as a consequence of joint breakdown, combined with the body’s


attempted repair process (Arthritis Research UK 2013, p6), and may affect multiple
joints. It is mainly degenerative in aetiology and is characterised by roughening and
thinning of cartilage, thickening of underlying bone with the formation of ‘bony spurs’,
and resultant narrowing of the gap between the bones (joint space). Additionally,
swelling may result from excess fluid in the joint (caused by thickening of the synovium
in the joint capsule), inflammation from the joint surfaces rubbing together, and the
capsule and ligament around the joint may thicken and contract, resulting in reduced
range of motion. The loss of cartilage, in severe cases, can lead to bone surfaces rubbing
together and wearing away.

­8 Hand and wrist orthoses for adults with rheumatological conditions


Introduction

Osteoarthritis results in a reduction in joint movement, and the main symptom of pain.
While it can affect any joint, it most commonly affects the knee and hip, where intervention
focuses on physical activity and pain management. Additionally the foot, ankle, hand and
wrist may be affected. Hand osteoarthritis commonly presents in the base of the thumb,
but may affect any joint, with characteristics of deformity, lasting pain, work disability, and
reduction in quality of life and overall function (Kloppenburg et al 2019, Gooberman-Hill et al
2013).

The management of osteoarthritis is set out in the NICE clinical guideline (NICE 2014b)
but there is, as yet, no disease-modifying anti-rheumatic drug (DMARD) therapy
available.

1.5.2 Rheumatoid arthritis


Rheumatoid arthritis is an inflammatory arthritis and may affect multiple joints. It affects
the body symmetrically and typically begins in the small joints of the hands and feet and
spreads proximally over time. The synovium of the joint becomes inflamed and
thickened, and forms a pannus that erodes both the cartilage and the underlying bone.
Genetics and smoking have been identified as risk factors (Versus Arthritis 2019b).

A systemic disease, rheumatoid arthritis can affect the whole body, including the lungs,
heart and eyes (NICE 2018), and can include neurological complications, such as carpal
tunnel syndrome (NICE 2019). Fatigue is a common feature and is reported to have an
impact on functional ability (McArthur et al 2015).

Key symptoms of rheumatoid arthritis in the upper limb include pain, joint swelling,
stiffness and muscle weakness. These can lead to impairment in hand function
(Hammond et al 2018b). People with long-standing rheumatoid arthritis, or those who
do not seek out services until their condition is worsened, may present with tendon and
joint problems. Joint deformities may affect the wrist and hand as a result of disease
damage to intrinsic and extrinsic structures. Typical presentations include ulnar drift of
the metacarpophalangeal joints and Boutonnière and swan neck deformities in the
fingers (Wu and Talwalker 2019).

The occupational therapy needs of those with early rheumatoid arthritis are different
from those of individuals with more long-standing disease. Both may have loss of
function due to joint pain but the aetiology of symptoms is different: that is,
inadequately controlled disease activity is typically the main factor for joint pain in early
disease; in disease of long duration there is also potential for pain due to altered body
mechanics secondary to joint damage, with or without disease activity. Clinical
interventions focus on ‘controlling pain and inflammation, reducing joint damage and
maintaining or improving physical function and quality of life’ (McArthur et al 2013,
p457).

Occupational therapists need to be aware of new treatments, such as biologic drugs and
Janus Kinase or JAK inhibitors. Both earlier diagnosis and biological therapies, such as
anti-tumour necrosis factor drugs (Anti-TNFα), have made a significant impact on the
management of rheumatoid arthritis (Siegel et al 2017). For some the use of these
disease-modifying treatments ‘has enabled people to move from a trajectory of long-
term decline to one of maintenance and potential improvement’ (McArthur et al 2015,
p854). Evidence supports the use of a range of occupational therapy interventions for
adults with rheumatoid arthritis; however, research has highlighted an increased need
for the availability of occupationally focused interventions (Siegel et al 2017).

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2 The occupational therapy role

The person-centred and holistic philosophy of occupational therapy underpins the


recommendations within this guideline.

Occupational therapists believe that the ability to engage in meaningful occupation is


fundamental to the facilitation and maintenance of health and wellbeing. By engaging
with occupations (activities we have to, need to, or want to do), we gain a sense of our
own being. It is not enough, however, to just ‘do and be’, we also need to engage in
meaningful occupations in order to become something in the future. (Royal College of
Occupational Therapists 2019, pp2–3)

Occupational therapy interventions should be informed by national clinical guidelines.

The NICE osteoarthritis clinical guideline (NICE 2014b) recommends a holistic


assessment and, within the context of non-pharmacological management, there are two
recommendations that are particularly pertinent to health professionals who prescribe
orthoses or assistive devices:

People with osteoarthritis who have biomechanical joint pain or instability should be
considered for assessment for bracing/joint supports/insoles as an adjunct to their core
treatments. (Recommendation 1.4.8)

Assistive devices (for example, walking sticks and tap turners) should be considered as
adjuncts to core treatment for people with osteoarthritis who have specific problems with
activities of daily living. If needed, seek expert advice in this context (for example from
occupational therapists or Disability Equipment Centres). (Recommendation 1.4.9)

Referral to occupational therapy services is recommended for people with hand


osteoarthritis:

This evidence suggests that those people with hand pain, difficulty and frustration with
performing daily activities and work tasks should be referred to occupational therapy for
splinting, joint protection training and assistive device provision. This may be combined
with hand exercise training. People should be referred early particularly if work abilities
are affected. (NICE 2014a, Section 8.6.5)

The NICE clinical guideline for rheumatoid arthritis (NICE 2018) makes direct reference
to occupational therapy:

People with RA should have access to specialist occupational therapy, with periodic review
if they have:

• Difficulties with any of their everyday activities, or


• Problems with hand function. (Recommendation 1.8.2)

The SIGN rheumatoid arthritis guideline (SIGN 2011) also includes a recommendation
for occupational therapy; however, the specific recommendation for ‘splinting’ is actually
included within a section on physiotherapy rather than indicating that this intervention

­10 Hand and wrist orthoses for adults with rheumatological conditions
The occupational therapy role

may be provided by a range of other health professionals (including occupational


therapists, hand therapists and orthotists):

Skilled occupational therapy advice should be available to those experiencing limitations


in function. (Recommendation 7.1.1)

Resting and working splints can be used to provide pain relief. (Recommendation 7.2.4)

The role of occupational therapy within rheumatology includes a variety of interventions


to support self-management, enhance function and facilitate independence. The
occupational therapy clinical guidelines for rheumatology (NAROT 2003b) identified key
areas for intervention: joint protection and energy conservation; psychological wellbeing
and self-management; sexuality, parenting and family relationships; employment; and
splinting.

Orthotics is a conservative intervention for wrists and hands that are affected by either
primary inflammation (e.g. rheumatoid arthritis) or degenerative processes (e.g.
osteoarthritis) with secondary inflammation (Bradley and Adams 2013). Daily activities
that require lifting or grabbing items may increase pain; therefore, support for joints
may decrease pain and improve function.

Assessment for, and provision of, wrist and hand orthoses is frequently used as part of
occupational therapy intervention when addressing the consequences of osteoarthritis
or rheumatoid arthritis on the hand and wrist. The use of orthoses for people with
arthritis has been identified for the following (Deshaies 2018):

• To reduce inflammation.
• To decrease pain.
• To support unstable joints.
• To properly position joints.
• To limit undesired motion.
• To increase range of movement.

The evidence for prescribing an orthosis is, however, variable and prescription should
therefore be underpinned by clinical reasoning based on ‘biomechanical and anatomical
knowledge’ (Bradley and Adams 2013, p191). Occupational therapists gain their
experience and expertise in the provision of an orthosis largely as a postgraduate and,
therefore, therapists must ensure they work within their scope of practice and
competence (COT 2015a).

The occupational therapist is advised to consider three areas within their clinical
decision-making: disease management, management of people who access services,
and management of mechanical function/dysfunction (Bradley and Adams 2013, p193).

An orthosis for the hand and wrist may include one or more of the following joints:

• The carpal joints, including the radiocarpal and distal radioulnar joints – wrist.
• Carpometacarpal joint (CMCJ) – base of the thumb (or trapeziometacarpal joint).
• Metacarpophalangeal joint (MCPJ) – between the distal ends of the metacarpal bones
and proximal phalanges of the fingers and thumb (the large knuckles of the hand).

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The occupational therapy role

• Proximal interphalangeal joint (PIPJ) – middle joint of the fingers.


• Distal interphalangeal joint (DIPJ) – end joint of the fingers.
• Interphalangeal joint (IPJ) – distal joint of the thumb.

Hand function is a global term but includes range of movement; sensation and
proprioception; dexterity/coordination; strength of grip; and a range of grip types.
Where any of these elements of function are affected, this can impact on the individual’s
occupational performance. An orthosis needs to support the joint being treated, but
fabrication and design should immobilise or restrict only joints that are the target of the
intervention and minimise restriction of other movements and of hand function.

Orthotic prescription must take account of individual preferences and needs, including
the complexities of treating people with multiple pathologies, or those with cognitive or
emotional disorders, dementia and learning disabilities. Where an individual requires
assistance to understand the potential benefits, risks and wearing regimen, or
assistance to don/doff their recommended orthosis, the occupational therapist, with the
person’s agreement, may need to liaise with family and/or paid carers. Any written
information provided should be fully accessible and/or clear and ‘easy to read’.

Occupational therapists should also take into account potential health inequalities and
any social determinants of health that may be applicable to the people who access
occupational therapy services (Marmot 2010, p15). Inequalities may be present for those
accessing services, for example through referral systems; provision of orthoses (e.g.
self-purchase requirements); accessible information (e.g. language used); and the
approach to the provision of an orthosis and impact on work capacity (health and safety
perspectives of orthosis wearing).

If an orthosis is required to be worn by an individual in the context of their paid


employment, additional factors may need to be considered, including health and safety,
hygiene and infection control issues. These will vary from one situation to another,
depending on the working environment and duties. The occupational therapist may
provide advice via an Allied Health Professional Health and Work Report (Allied Health
Professions Federation 2019), and/or the individual may need to be advised to seek
guidance from their employer and/or occupational health advisor before wearing the
orthosis at work. The occupational therapist may need to consider offering alternative
designs, materials and strapping to assist the individual in achieving adherence to the
relevant requirements of their employment.

This practice guideline focuses on orthoses, but this is just one intervention that
occupational therapists can offer individuals with rheumatological conditions involving
the hand and wrist. The prescription of an orthosis should not be seen in isolation but
within the context of a comprehensive assessment and individually tailored intervention
plan. Information provided as part of an individualised care plan may include
signposting to publicly available resources, such as those available from Versus Arthritis
and the National Rheumatoid Arthritis Society. These third-sector agencies provide
online information and user-friendly leaflets on the role of occupational therapy in
overcoming everyday difficulties – for example, Living better with rheumatoid arthritis
(National Rheumatoid Arthritis Society 2018) and What are wrist and hand splints? (Versus
Arthritis 2018).

Ongoing access to a multidisciplinary team and a holistic assessment is an important


part of the management of arthritis pathways (NICE 2014a). It is recognised that in a
multidisciplinary team, there may be some key areas of occupational therapy

­12 Hand and wrist orthoses for adults with rheumatological conditions
The occupational therapy role

assessment and intervention that overlap with the role of other health and social care
personnel. Where an occupational therapist is unable to provide the required
intervention, they should discuss the options for onward referral, to an appropriate
service, with the individual.

Occupational therapy staff must work alongside other professionals in accordance with
local service arrangements to ensure the needs of the individual are met. Good
communication across the primary/secondary care interface, and between health, social
care, the independent and voluntary sectors, is imperative.

The Elizabeth Casson Memorial Lecture 2014 (Hammond 2014) provides a valuable
overview and discussion of the changing role of occupational therapy practice and
research within the field of rheumatology over the past 30 years; self-management and
joint protection programmes; and how therapists might need to change to implement
evidence-based practice.

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3 Objective of the guideline

The guideline objective is:

To provide evidence-based recommendations that inform the practice of


occupational therapists working with adults over 16 years of age who have
rheumatological conditions, and who may benefit from a custom-made or
prefabricated hand or wrist orthosis.

The inflammatory and degenerative processes associated with rheumatological


conditions can impact on hand and wrist structures. Clinical reasoning enables a
practitioner to determine whether the prescription of a hand or wrist orthosis may have
the potential to improve symptoms such as pain and reduced function (Bradley and
Adams 2013).

The objective addresses occupational therapy intervention at any point during an


individual’s journey along the rheumatology care pathway.

It is intended that occupational therapists use this guideline to inform their work, with a
particular focus on empowering the person to fully engage and take responsibility for
achieving their individual goals.

The application of the guideline will also inform the delivery of evidence-based services.
This guideline should be used in conjunction with the current versions of the following
professional practice documents, of which knowledge and adherence is assumed:

• Standards of conduct, performance and ethics (Health and Care Professions Council
[HCPC] 2016).
• Standards of proficiency – occupational therapists (HCPC 2013).
• Code of ethics and professional conduct (COT 2015a).
• Professional standards for occupational therapy practice (COT 2017).

Occupational therapists should also be familiar with their relevant country-specific policy
documents and performance measures, and cognisant of the following guidelines:

• Osteoarthritis. Care and management in adults (NICE 2014b).


• Rheumatoid arthritis in adults: management (NICE 2018).
• Quality standard for rheumatoid arthritis (NICE 2013, updated 2020).
• Management of early rheumatoid arthritis (SIGN 2011).
• 2018 update of the EULAR recommendations for the management of hand osteoarthritis
(Kloppenburg et al 2019).

The occupational therapist prescribing an orthosis must also give due consideration to
any guidance from the Medicines and Healthcare Products Regulatory Agency on
prosthetic and orthotic devices.

­14 Hand and wrist orthoses for adults with rheumatological conditions
Objective of the guideline

Occupational therapists must only ‘provide services and use techniques for which [they]
are qualified by education, training and/or experience’, and within their professional
competence (COT 2015a, p32). This guideline should be used in conjunction with the
therapist’s clinical expertise and, as such, the clinician is ultimately responsible for the
interpretation of the evidence-based recommendations in the context of their specific
circumstances and the person’s individual needs.

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4 Guideline scope

4.1 Clinical questions


The key questions identified in the scope for this guideline were:

• Is there evidence to support the use of hand and wrist orthoses as an intervention
for adults living with rheumatological conditions?
• Is there any evidence of harm arising from the use of an orthosis that practitioners
should be aware of?

Egan et al (2001), in their Cochrane review of splints and orthoses for treating
rheumatoid arthritis, referred to both commonly used terms – splint and orthosis. The
guideline development group recognised that occupational therapists may potentially
use either term but agreed that, for consistency, ‘orthosis’ rather than ‘splint’ would be
the terminology used in the guideline. The evidence review in Section 5 and evidence
tables in Appendix 6, however, adopt the terminology of the published article reviewed.

An orthosis or orthotic device is an:


‘Externally applied device used to modify the structural and functional characteristics
of the neuromuscular and skeletal systems’. (International Organization for
Standardization 1989)

4.1.1 Key outcomes


The guideline development group members identified key outcomes for orthotic
intervention, from their knowledge of the evidence base and clinical expertise.

Orthotic intervention should optimise an individual’s occupational performance by


improving:

• Pain
• Swelling
• Deformity (including hand appearance)
• Self-efficacy
• Dexterity
• Sensory symptoms
• Grip strength
• Range of movement (ROM)
• Quality of life
• Self-management strategies.

­16 Hand and wrist orthoses for adults with rheumatological conditions
Guideline scope

The heterogeneity of the population means that it can be difficult to identify the
specific outcomes that will be the most important to an individual. A person-centred
perspective underpins occupational therapy practice, and intervention must be
compatible with the person’s preferred outcomes or, where appropriate, in their best
interest (considering lack of capacity and conditions such as dementia).

4.1.2 Key areas for inclusion in the guideline scope


The first key area for inclusion in the guideline scope is orthotic interventions as an
objective experience, including:

• The clinical reasoning of the therapist and rationale for orthotic interventions.
• The physical outcomes, such as biomechanical/structural support and symptom relief.
• Provision of information to the person accessing services regarding wear and care of
an orthosis.
• Contraindications and/or risks.
• Difficulties with the application of an orthosis, wear, care and functional ability.

The second key area is orthotic interventions as a subjective experience, including:

• Satisfaction of the person accessing services.


• Therapeutic contextual factors, such as self-management strategies.

4.1.3 Key areas for exclusion from the guideline scope


The scope also clarified areas which would not be covered:

• How to fabricate an orthosis, due to the wide range of available materials and designs
which are specific to the person, as well as being dependent on the skill mix of the
therapist.
• Post-operative orthoses for the hand and wrist, due to the specialised nature of this
area of practice, which is often provided within an orthopaedic service.
• Orthotic interventions for the hand and wrist outside the specialism of rheumatology;
for example, splinting for adults with neurological conditions (COT 2015b).
• Hand assessment, as the focus of the guideline is on the intervention and not on
biomechanical assessment.

The focus is on orthotic interventions to manage the signs and symptoms of the
underlying pathology, and address the functional impairments within the hand. This
guideline should, however, be considered alongside global treatment strategies for
facilitating improved hand function and occupational performance.

4.2 Target population


The population to whom this practice guideline applies is those adults with
rheumatological conditions who may benefit from an orthosis for the hand or wrist.

To further define the target population:

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Guideline scope

• Adults are defined as any person aged 16 years and over. There is no upper age limit.
• Underlying pathologies are inflammatory arthropathies, with either primary
inflammation (e.g. rheumatoid arthritis) or secondary inflammation (e.g.
osteoarthritis).
• There are no restrictions/limitations on gender, ethnicity or cultural background.
• There are no exclusions for severity of the rheumatological condition or for
comorbidities; however, each person should be assessed individually (taking into
account relevant comorbidities) when determining appropriate care or action specific
to the guideline recommendations.

Children under the age of 16 years are excluded, given the variation in clinical rationale
and service provision compared with provision for adults. Orthotic intervention for this
age group is different, due to the developmental implications, and may have different
presentations to adult arthritis (e.g. juvenile idiopathic arthritis), and there is a scant
evidence base to support the use of orthoses with children (Dunbar et al 2017, Helders
et al 2002).

Specific conditions where the provision of an orthosis is a rarity, such as crystal


arthropathy, are also excluded from the guideline scope.

4.3 Target audience


The principal audience for this practice guideline is occupational therapists who
prescribe orthoses as an intervention for adults with a rheumatological condition.

This guideline is applicable to occupational therapy staff delivering services to adults in a


range of settings, including community occupational therapy services, and rheumatology
outpatients, inpatients and day care units.

This practice guideline will also be relevant to a wider audience:

• Hand therapists, physiotherapists and orthotists who prescribe orthoses: as a


reference tool to guide their practice.
• Managers and commissioners: to provide evidence of the role of occupational therapy
with adults who may benefit from an orthosis in terms of their health and wellbeing
outcomes, and thus inform business planning and commissioning of services.
• Members of the multidisciplinary team (MDT): to provide a greater understanding of
the role of the occupational therapist in prescribing orthoses. This guideline, while
being particularly pertinent to occupational therapists, will have relevance to a range
of professionals who regularly come into contact with people who have arthritis. For
example, as members of the MDT, nurses are often the first point of contact for
people in a range of different settings, such as GP practices, community services or
outpatient clinics. For these professionals, having more awareness of the potential
benefits of hand and wrist orthoses for people with arthritis would enable them to
make informed, evidence-based decisions regarding referral to the occupational
therapists for assessment for hand orthotics. In some instances this may mean
referring to a specialist hand therapy service. Additionally, as part of their
consultation, members of the MDT can encourage people to engage in all aspects of
their care. For example, this may be by encouraging those who have been provided
with hand or wrist orthotics to comply with their wearing regimes or to contact the
occupational therapist if they require further advice. This will promote closer working

­18 Hand and wrist orthoses for adults with rheumatological conditions
Guideline scope

between disciplines (including nursing, medical and other multidisciplinary team staff),
with the potential for improved outcomes for people who access services.
• Education providers: as an educational tool, orientating individuals to an evidence-
based resource to support orthotic interventions, and the role of occupational therapy
in providing orthoses for rheumatological conditions (e.g. occupational therapy and
physiotherapy students, student orthotists, technical instructors).
• People who access services and their carers: providing information to enable them to
be more informed about the occupational therapy process and orthotic interventions.

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5 Recommendations and
supporting evidence

Update 2022: new research on the clinical and cost-effectiveness of compression gloves
published after a review of this guideline has necessitated an amendment to the 2020
edition (see addendum).

The recommendations developed by the guideline development group are underpinned


by the evidence available to date which supports the use of hand and wrist orthoses as
an intervention for adults with rheumatological conditions. They also take into account
evidence on risks or harm from the use of an orthosis (see Section 4.1, Clinical
questions). Details of the guideline methodology, including the literature search strategy
and the development process, are set out in Sections 9, 10 and 11.

Synthesis of the evidence resulted in the emergence of recommendations for orthotic


prescription in the context of three core areas:

• Rheumatoid arthritis: orthoses for activity and rest.


• Osteoarthritis: base of thumb orthoses.
• Optimising outcomes for people who access services.

The three themes cut across the desired outcomes identified (see Section 4.1), but while
the recommendation statements have been set out within three categories, it is
essential to recognise that there are overlaps. Individual recommendations should not
be considered in isolation but in the wider context.

Where available, qualitative feedback from people who accessed services obtained
during the guideline consultation has been used to provide a user perspective as an
adjunct to the published evidence.

The strength of the recommendations is identified via a scoring of 1 (strong) or 2


(conditional), and the quality of the supporting evidence via a grading on a scale of A
(high quality) to D (very low quality). A recommendation grading takes into account
consistency in the direction of outcomes from the individual items of evidence used to
support that recommendation.

Four of the eight recommendations were agreed by the guideline development group as
being strong: that is, most individuals would want to, or should, receive the course of
intervention or action stated. The other four recommendations were conditional: that is,
the majority of individuals would want the intervention, but not all would, with the risks
and benefits being more closely balanced.

Additional details on individual studies (for example, on study design, methodological


limitations, recruitment numbers and statistical significance) can be accessed in the
evidence tables (Appendix 6).

­20 Hand and wrist orthoses for adults with rheumatological conditions
Recommendations and supporting evidence

Outcomes desired, risks, generalisability and social determinants of health associated


with the recommendations are outlined in Section 5.4. Potential financial and
organisational barriers are discussed in Section 7.2.

This guideline focuses specifically on the prescription of orthoses, as defined in the


scope, and does not set out to compare orthoses with other interventions. This is in line
with the PICO framework (Huang et al 2006, Richardson et al 1995), which, for this
guideline, did not specify a comparative intervention (Section 10.1). Alternative
management options are therefore not explicitly reviewed or discussed. Occupational
therapists should, however, be aware of the range of other interventions that they may
provide, or that may be within the remit of other members of the multidisciplinary team.

Recommendations are based on a synthesis of the best available evidence (sourced


from English language publications). It should, therefore, be noted that the guideline is
not able to reflect the full range of orthotic interventions for rheumatological conditions
that can be provided by occupational therapists.

5.1 Rheumatoid arthritis: orthoses for activity and rest


Rheumatoid arthritis: orthoses for activity and rest
Functional wrist orthoses
1. It is recommended that a functional wrist orthosis should be prescribed 1A
for people experiencing wrist pain as a result of rheumatoid arthritis.
(Ramsey et al 2014 [A]; Thiele et al 2009 [C]; Veehof et al 2008a [B]; Pagnotta
et al 2005 [C]; Haskett et al 2004 [B])
Resting/night orthoses
2. It is suggested that where a night or resting orthosis is being considered 2B
as potentially beneficial to reduce symptoms for a person with
rheumatoid arthritis, both subjective and objective measures are used for
the monitoring and review of effectiveness.
(Adams et al 2008 [B]; Silva et al 2008 [A])
Orthoses for swan neck deformity
3. It is suggested, when considering an orthosis for swan neck deformity, 2C
that a potential positive effect on dexterity should be balanced by possible
adverse effects such as pressure and paraesthesia.
(Giesen et al 2010 [D]; Giesen et al 2009 [C]; Spicka et al 2009 [D]; Zijlstra et al
2004 [C])

5.1.1 Introduction
Orthoses for rheumatoid arthritis are prescribed for a number of reasons. They can be
used to ‘provide support, reduce pain, prevent undesirable motion during occupational
performance, increase range of movement or prevent deformity and position joints for
occupational performance’ (Yasuda 2008, pp1226–1227).

An orthosis provided for an individual for use at night, or during rest, is based on the
premise that this will maintain the hand in an anatomical position of rest, with the

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Recommendations and supporting evidence

potential to reduce both localised pain and inflammation. The orthosis should support
the joints in rested positions that ‘place the least internal pressure on them and are
opposite that of the potential deformity’ (Deshaies 2018, p962).

People with rheumatoid arthritis may also be prescribed and provided with functional
wrist orthoses. These orthoses are designed to be worn while active, as opposed to rest,
and aim to provide stability, decrease pain and improve function (Deshaies 2018).

Swan neck deformity with hyperextension at the proximal interphalangeal joint and
flexion at the distal interphalangeal joint is the result of muscle imbalance, which may
include intrinsic tightness with associated metacarpophalangeal flexion. The deformity
may be caused by the destructive effects of synovitis and initiated at any one of the
digital joints (Deshaies 2018). Proximal interphalangeal joint motion can become limited,
resulting in significant loss of digital function. The provision of an orthosis (for one or
more fingers) to position the proximal interphalangeal joint in approximately 5° of
flexion aims to make it easier for the person to activate the flexor digitorum superficialis
tendon and initiate flexion of the proximal interphalangeal joint. The orthosis may be a
mass-produced or custom-made thermoplastic (figure-of-eight) design, or sterling silver
(commonly called a silver ring splint), typically custom-made by a jeweller or available
from some suppliers.

The medical management of rheumatoid arthritis has changed, however, with modern
biologic treatment regimens resulting in more effective control of inflammation for
some individuals. Earlier diagnosis, with the advent of tight control disease-modifying
anti-rheumatic drug regimens (DMARD), has also improved outcomes (Chakravarty et al
2008, Siegel et al 2017). Occupational therapists will work with individuals who may have
a range of symptom presentation: those whose symptoms are more effectively
controlled and those, often older people, whose joint deformity and instability pre-date
more recent management options (Bradley and Adams 2013).

5.1.2 Functional wrist orthoses

Rheumatoid arthritis: orthoses for activity and rest


Functional wrist orthoses
1. It is recommended that a functional wrist orthosis should be prescribed 1A
for people experiencing wrist pain as a result of rheumatoid arthritis.
(Ramsey et al 2014 [A]; Thiele et al 2009 [C]; Veehof et al 2008a [B]; Pagnotta
et al 2005 [C]; Haskett et al 2004 [B])

A mixed methods systematic review (Ramsey et al 2014) addressed the effectiveness of


functional wrist orthoses used by people with rheumatoid arthritis. A total of 23 studies
were included in the review and the data analysis indicated that pain was reduced by the
use of functional wrist orthoses. The qualitative study synthesis provided additional
evidence for this benefit by identifying that pain reduction and decreasing swelling were
primary reasons for orthosis use from the individual’s perspective. The other key
outcomes considered were grip, function and dexterity. While there may be moderate
improvement in grip, evidence of the effect on function was inconclusive, and that on
dexterity indicated that it could be negatively affected. The need for dexterous
manipulation is likely to result in non-use for those tasks; indeed, impact on function
was suggested as being task-specific.

­22 Hand and wrist orthoses for adults with rheumatological conditions
Recommendations and supporting evidence

An important finding of the review was the heterogeneous nature of the variables
described in the studies – for example, disease duration, orthosis type, wearing regimen
and intervention period. As a result of this variation, definitive recommendations on
orthosis type and wearing regimen could not be developed.

Thiele et al’s (2009) Australian cross-over trial explored the effectiveness of a leather
wrist orthosis compared with a fabric wrist orthosis. This study recruited 25 participants,
with a two-week follow-up and a one-week washout period. Outcomes included were
pain, function and stiffness (using the Australian/Canadian Osteoarthritis Hand Index),
and grip strength. Additionally, self-reported occupational performance in activities of
daily living was measured via the Canadian Occupational Performance Measure (COPM).
Between baseline and follow-up, both orthosis design groups showed statistically
significant reduced pain, improved function and grip strength (all p<0.05) with no
increase in wrist stiffness.

Veehof et al’s (2008a) randomised controlled trial in the Netherlands investigated the
effectiveness of functional wrist orthoses. Thirty-three participants were recruited, 17 of
whom were allocated to an intervention group. Participants were randomised to receive
either usual care (n=16) or a choice of one of four different prefabricated orthoses. The
orthosis was worn as much as possible during the day for four weeks. The primary
outcome was a reduction in wrist pain, with secondary outcomes of improved grip
strength and functional ability.

Pain scores reduced by 32% in the orthosis group compared with 17% in the control
group: a significant difference. There was no significant change between the groups in
grip or functional ability. The study suggests that prefabricated wrist orthoses are highly
effective in reducing wrist pain, after four weeks of wearing, for people with rheumatoid
arthritis.

A Canadian cohort study carried out by Pagnotta et al (2005) aimed to determine the
influence of a wrist orthosis on pain, work performance, perceived task difficulty and
orthosis benefit. Impact was measured using a work simulator to assess work
performance and endurance with the orthosis both on and off.

Thirty participants wore a prefabricated wrist orthosis to undertake 14 tasks, the work
simulator generating computer readouts for performance and endurance. Pain was
rated before and after each task. Wearing the orthosis did not interfere with work
performance; improved or did not change pain levels; and increased or maintained
endurance. The perceived difficulty for completing most tasks did not increase as a
result of wearing the orthosis.

Haskett et al (2004) compared the effect of three different orthoses in a randomised


controlled trial in Canada. Forty-five participants were randomly assigned to wear either
a Rolyan® wrist extensor orthosis, a custom-made leather wrist orthosis or an
Anatomical Technologies elastic wrist support. Each orthosis, fitted by an occupational
therapist, was to be worn for activities during the day that caused pain or discomfort, for
four weeks. There was a washout period of one week between wearing each orthosis.

The primary outcome was to reduce pain, and all three orthoses reduced pain compared
with baseline (p=0.007), although the leather wrist orthosis demonstrated a greater
benefit in terms of pain reduction. The researchers considered this may be related to the
custom-fitting of the leather orthosis, although there is no comment on the possible
contribution that the material of the leather orthosis (which would be stiffer), or the wrist
positioning (noted at 5° ulnar deviation), may also have had on achieving greater pain

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Recommendations and supporting evidence

reduction. After the four-week intervention period, grip and pinch strength were
improved in all groups, although the clinical significance of the very small change
recorded is uncertain. The orthosis did not appear to compromise dexterity.

The cost of the leather wrist orthosis (including fitting and participant instruction) was
2–3 times greater than for the other two orthoses. The superiority of the leather wrist
orthosis for pain relief supports the Thiele et al (2009) trial. However, while pain
reduction and participant preference favoured the leather orthosis, the differences
between it and the Rolyan® wrist extensor orthosis were considered not significant
enough to warrant the cost of the custom-made version.

Evidence overview
The evidence for the use of functional wrist orthoses for people with rheumatoid
arthritis is strong with respect to the reduction of pain, as particularly evidenced by
the systematic review undertaken by Ramsey et al (2014). A decrease in pain was a
consistent outcome across the studies, as measured using visual analogue scales.
The reduction of symptoms, such as pain, is also a key motivator for adherence to
wearing an orthosis.

Risks associated with wearing a functional wrist orthosis were not specifically
reported in the studies, but a potential negative impact on dexterity was highlighted.

Resting/night orthoses

Rheumatoid arthritis: orthoses for activity and rest


Resting/night orthoses
2. It is suggested that where a night or resting orthosis is being considered 2B
as potentially beneficial to reduce symptoms for a person with
rheumatoid arthritis, both subjective and objective measures are used for
the monitoring and review of effectiveness.
(Adams et al 2008 [B]; Silva et al 2008 [A])

The effectiveness of a static resting orthosis was evaluated in a UK randomised


controlled trial undertaken by Adams et al (2008). The participants included in this
research had a confirmed diagnosis of rheumatoid arthritis, with a disease duration of
less than five years. A static resting thermoplastic orthosis and standardised occupational
therapy intervention were provided to the intervention group (n=60) while the control
group (n=60) received the standardised occupational therapy intervention only.

The orthosis in this study was worn during the day when resting (and when hands were
warm, red, tender or swollen), with incremental increase in wearing time per day.
Participants were also encouraged to wear the orthosis on alternate nights.

Measures were taken at baseline and at the 12-month period by a blinded assessor. At
12 months there was no statistically or clinically significant difference in the change in
grip strength, hand deformity or pain between the control group and the intervention
group. There was an indication that the static orthosis might provide some benefit in the
occurrence of early morning hand stiffness, but not in its duration. The control group
improved in almost all outcomes compared with the intervention group.

­24 Hand and wrist orthoses for adults with rheumatological conditions
Recommendations and supporting evidence

Participants’ self-reported views on effectiveness, however, contradicted those of the


outcome measures. In the intervention group, 84% (n=47) perceived the orthosis to be
effective, although 24% (n=12) of the group reported they had never worn the orthosis,
and a further 20.4% (n=10) wore the orthosis for less than five hours per week.

The research raises an interesting discrepancy between the outcomes of objective and
subjective measures, but the outcomes appeared to suggest that adding a static resting
hand orthosis to standardised occupational therapy intervention is not indicated for
people with early rheumatoid arthritis.

Silva et al (2008) conducted a randomised controlled trial, in Brazil, to evaluate the


effectiveness of using a night-time positioning orthosis for the hand. The focus was on
the impact of the orthosis on pain, grip, pinch strength, upper limb function and also on
the individual’s satisfaction. The intervention group (n=25) wore a night-positioning
orthosis, while the control group (n=25) wore the orthosis only during the evaluations at
baseline, at 45 and at 90 days. The thermoplastic orthosis was custom-made, by an
occupational therapist, and the material could be adjusted after fabrication if any
discomfort was caused by pressure points. The mean disease duration for participants
in this study was 9–10 years. No other upper limb therapy was provided during the
course of the three-month study period.

The intervention group demonstrated a significant improvement compared with the


control group (p<0.005) across all domains measured. The authors’ belief was that a
reduction in the inflammatory process resulted in a decrease in pain, enabling an
individual to use their strength to best effect. As a consequence, improved performance
in activities of daily living was reported.

The perspective of participants in the intervention group, established through a Likert


satisfaction scale, was that at three months 44% indicated they felt ‘better’ and 44% felt
‘much better’ with the use of the orthosis. The reasons for satisfaction levels expressed
were not reported.

The authors concluded that a night-time resting hand orthosis, compared with no
intervention, reduced pain in the hand, improved grip and pinch strength, and increased
upper limb function and functional status, as determined after wearing the orthosis for
three months.

Evidence overview
The effectiveness of a resting or night-positioning orthosis is not definitive. While the
outcomes from the two studies are potentially divergent in direction of benefit, it is
important to note the different inclusion criteria and any variations in orthosis design
and hand positioning.

A positive impact on hand pain, grip and pinch strength, upper limb function and
functional status was reported for participants with a mean of 9–10 years’ disease
duration, although the benefits beyond three months’ use were not researched.

The evidence reviewed does not enable a specific recommendation to be made with
respect to the prescription of a resting or night-positioning orthosis for people with
rheumatoid arthritis. The two studies do, however, identify the importance of using
subjective perspectives of individuals accessing services and objective outcome
measures to monitor progress and effectiveness of any orthosis prescribed.

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Recommendations and supporting evidence

5.1.3 Orthoses for swan neck deformity


Rheumatoid arthritis: orthoses for activity and rest
Orthoses for swan neck deformity
3. It is suggested, when considering an orthosis for swan neck deformity, 2C
that a potential positive effect on dexterity should be balanced by possible
adverse effects such as pressure and paraesthesia.
(Giesen et al 2010 [D]; Giesen et al 2009 [C]; Spicka et al 2009 [D]; Zijlstra et al
2004 [C])

A qualitative study performed by Giesen et al (2010) explored hand function difficulties


and influences on the selection of either the silver ring splint or the commercial
thermoplastic orthosis. Two questions were asked: one about the participant’s main
difficulties experienced because of the swan neck deformity(ies) and the second about
the reasons for their orthosis preference. Positive categories for orthosis choice focused
on its effect on hand function or pain, ease of use, appearance and comfort. Categories
that reflected negative reasons influencing choice were side effects; sharp edges;
sweating; pain in adjacent finger due to friction; paraesthesia of splinted fingertip;
slipping off and change of fit during wear. The range of factors potentially influencing
choice needs to be considered as part of the process of orthotic prescription.

A randomised cross-over trial also undertaken in the Netherlands by Giesen et al (2009)


with 50 participants with swan neck deformity compared the effectiveness of a silver
ring splint with a commercial thermoplastic orthosis (Oval-8®). The participants used
each orthosis for a period of four weeks, with a washout period of two weeks.
Participants subsequently used their preferred orthosis for another 12 weeks;
satisfaction and preferences were also investigated.

Dexterity was the primary outcome, measured using the Sequential Occupational
Dexterity Assessment (SODA), and results indicated that both orthoses increased
dexterity to a similar extent, and both reduced dexterity-related pain. The presence of
a nodule causing interference, or more frequently a minor skin problem, was reported
by a small number of participants. Both orthoses were found to be acceptable to
participants, although overall the satisfaction scores for the silver ring splint were
higher after four weeks, and were significantly higher for three satisfaction items after
the 12-week preferred orthosis period.

Spicka et al (2009) conducted an observational pilot study to investigate how silver ring
splints (three-point ring orthosis) might impact on grip strength and dexterity of the
hand in participants with deformity of the proximal interphalangeal joints. While this
small-scale UK study (n=8) provided only tentative findings because it was not powered
to detect significant differences, it suggested that hand dexterity and grip may show a
trend towards improvement when silver ring splints are worn.

The effect of silver ring splints on hand function for individuals with rheumatoid arthritis
was studied over the course of a year in the Netherlands by Zijlstra et al (2004). One or
more silver ring splints were fitted to proximal and distal interphalangeal joints of
affected fingers and interphalangeal joint of thumbs of 17 participants. Data analysis
identified a statistically significant improvement in dexterity, as measured by the SODA;
there were no statistically significant changes in pain, grip and pinch strength, and only
slight improvement in hand and finger function at one month.

­26 Hand and wrist orthoses for adults with rheumatological conditions
Recommendations and supporting evidence

Adverse effects were highlighted in the study: two participants dropped out, while 33%
of the silver ring splints were discarded after one year. Reasons included intolerance of
the orthosis, pressure of the splints on bony edges, rheumatoid nodules and
paraesthesia. Silver ring splints were identified as being potentially less acceptable for
long-standing finger deformities due to the degree of force needed to correct them,
but having the ability to improve dexterity in selected individuals. It should also be
noted that, given the publication date of 2004, the participants are unlikely to have had
the opportunity to receive many of the current biological therapies, so they may not be
fully representative of the current rheumatoid arthritis population.

Evidence overview
Some evidence exists to support prescription of an orthosis to improve dexterity
where correctable swan neck deformity exists for people with rheumatoid arthritis.
Impact on other dimensions, such as dexterity-related pain and function, is weaker.

Inherent with the use of silver ring splints or Oval-8® ring orthoses is the potential for
some adverse side effects, and the range of both positive and negative factors
influencing choice should be considered as part of the orthotic prescription process.
The recipients of an orthosis for swan neck deformity need to be carefully selected,
as factors such as long-standing deformity may mean an orthosis is not tolerated.

5.2 Osteoarthritis: base of thumb orthoses


Osteoarthritis: base of thumb orthoses
Orthoses to reduce pain and/or improve function
4. It is recommended that an orthosis should be prescribed for people 1A
experiencing pain and/or functional difficulties with activities of daily living
as a result of thumb base osteoarthritis.
(Cantero-Téllez et al 2018 [B]; Vegt et al 2017 [B]; Bani et al 2014 [C]; Hamann
et al 2014 [D]; Hermann et al 2014 [B]; Maddali-Bongi et al 2014 [C]; Bani et al
2013a [C]; Bani et al 2013b [A]; Becker et al 2013 [B]; Kjeken et al 2011a [A];
Kjeken et al 2011b [A]; Sillem et al 2011 [B]; Gomes Carreira et al 2010 [B];
Boustedt et al 2009 [C]; Moe et al 2009 [A]; Rannou et al 2009 [A]; Egan and
Brousseau 2007 [B]; Wajon and Ada 2005 [A]; Weiss et al 2004 [C])
[New evidence 2020]
Orthoses to improve grip and pinch strength
5. It is suggested that an orthosis can improve the grip/pinch strength for 2C
some people with thumb base osteoarthritis.
(Bani et al 2014 [C]; Hermann et al 2014 [B]; Maddali-Bongi et al 2014 [C];
Bani et al 2013a [C]; Bani et al 2013b [A]; Becker et al 2013 [B]; Sillem et al
2011 [B]; Wajon and Ada 2005 [A]; Weiss et al 2004 [C])

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Recommendations and supporting evidence

5.2.1 Introduction
The American College of Rheumatology (ACR) guideline for osteoarthritis (Kolasinski et al
2020) strongly recommends that individuals with osteoarthritis involving the thumb
carpometacarpal joint should be provided with a hand orthosis. For those with
osteoarthritis in other joints of the hand, orthoses are conditionally recommended, and
the guideline further states that they ‘would likely benefit from evaluation by an
occupational therapist’ (Kolasinski et al 2020, p7). Other relevant recommendations
include self-efficacy and self-management programmes (strongly recommended), and
thermal interventions (conditionally recommended).

The European League Against Rheumatism (EULAR) makes 10 recommendations for the
treatment of hand osteoarthritis based on a combination of research-based evidence
and clinical expertise (Kloppenburg et al 2019). One of these recommendations states
that ‘orthoses should be considered for symptom relief in patients with thumb base
osteoarthritis’ and that long-term use (greater than three months) is advocated
(Kloppenburg et al 2019, p17).

The term ‘thumb base osteoarthritis’, or ‘base of thumb osteoarthritis’, is used in this
guideline. Studies include those that referred to the first carpometacarpal joint or
trapeziometacarpal joint, although these did not always differentiate whether this
involvement was ‘with or without scapho-trapezoid joint osteoarthritis’ (Zhang et al 2009,
p9). Primary research studies of orthoses for thumb base osteoarthritis include those
investigating a single orthosis, comparisons between two orthoses of different design,
and those studies in which other interventions are provided alongside an orthosis. It is
also relevant to note emerging findings from a pilot randomised controlled trial in which
it was found that placebo orthoses were credible (Adams et al 2019, Adams et al 2014).

5.2.2 O
 rthoses to reduce pain and improve function, grip and
pinch strength

Osteoarthritis: base of thumb orthoses


Orthoses to reduce pain and/or improve function
4. It is recommended that an orthosis should be prescribed for people 1A
experiencing pain and/or functional difficulties with activities of daily living
as a result of thumb base osteoarthritis.
(Cantero-Téllez et al 2018 [B]; Vegt et al 2017 [B]; Bani et al 2014 [C]; Hamann
et al 2014 [D]; Hermann et al 2014 [B]; Maddali-Bongi et al 2014 [C]; Bani et al
2013a [C]; Bani et al 2013b [A]; Becker et al 2013 [B]; Kjeken et al 2011a [A];
Kjeken et al 2011b [A]; Sillem et al 2011 [B]; Gomes Carreira et al 2010 [B];
Boustedt et al 2009 [C]; Moe et al 2009 [A]; Rannou et al 2009 [A]; Egan and
Brousseau 2007 [B]; Wajon and Ada 2005 [A]; Weiss et al 2004 [C])
[New evidence 2020]
Orthoses to improve grip and pinch strength
5. It is suggested that an orthosis can improve the grip/pinch strength for 2C
some people with thumb base osteoarthritis.
(Bani et al 2014 [C]; Hermann et al 2014 [B]; Maddali-Bongi et al 2014 [C];
Bani et al 2013a [C]; Bani et al 2013b [A]; Becker et al 2013 [B]; Sillem et al
2011 [B]; Wajon and Ada 2005 [A]; Weiss et al 2004 [C])

­28 Hand and wrist orthoses for adults with rheumatological conditions
Recommendations and supporting evidence

Cantero-Téllez et al (2018) compared the short-term effect of an orthosis where the


thermoplastic material included the metacarpophalangeal joint with an orthosis that did
not include the metacarpophalangeal joint among 66 participants with thumb
carpometacarpal osteoarthritis. Participants were randomly assigned to an orthosis
group and instructed to wear it at night and 3–4 hours a day during activities of daily
living. Pain (measured via a visual analogue scale) and hand function (measured via the
Quick Disabilities of the Arm, Shoulder and Hand [QuickDASH]) recordings were taken at
baseline and one week after the start. Pain scores in both groups reduced significantly
(from 77 to 46 in the group whose orthoses included the metacarpophalangeal joint and
from 77 to 48 in the other group, p<0.001 for both). A significant improvement in
function was also seen, with QuickDASH scores decreasing from 40.2 to 36.1 in the
group whose orthoses included the metacarpophalangeal joint and from 41.7 to 35.7 in
the other group (p<0.001 for both).

A cross-over randomised controlled trial undertaken by Vegt et al (2017) investigated


differences in outcomes between the Push Ortho Thumb Brace CMC and a custom-
made orthosis for participants with osteoarthritis of the carpometacarpal joint of the
thumb. The Push Ortho Thumb Brace CMC is an off-the-shelf, semi-rigid orthosis that
immobilises the carpometacarpal joint. The custom-made orthosis was rigid and
immobilised the carpometacarpal and metacarpophalangeal joints. Sixty-three
participants used each orthosis for two weeks with a two-week washout period. Both
orthoses reduced pain and improved hand function, but the Push Ortho Thumb Brace
CMC reduced pain significantly more (p=0.008) while the custom-made orthosis
increased hand function (as measured via the Nine Hole Peg Test) significantly more
(p<0.001). Key grip strength was significantly reduced with both orthoses, but
significantly more with the custom-made orthosis (p=0.001).

A cohort study was conducted by Bani et al (2014) using a custom-made neoprene


carpometacarpal joint orthosis with thermoplastic stabilisation. Eleven participants were
recruited, and the prescribed orthosis left the wrist and metacarpophalangeal joints
free. Results demonstrated a reduction in pain and an improvement in function, grip
strength and pinch strength.

Hamann et al (2014) compared four different types of orthoses for thumb


carpometacarpal osteoarthritis in an attempt to identify the stabilisation and
functionality of each. They tested the Rhizo Forte V/2013, the Ortho CMC Push Brace, the
Rhizo-Hit® and the Rhizomed®. Eighteen female participants wore each orthosis during
a series of tests to measure stabilisation and hand function. The study found that all
types of orthoses restricted motion, though hand function (assessed via the Sollerman
test) was highest with the Ortho CMC Push Brace and lowest with the Rhizomed®. Both
differed significantly from the other orthoses (p<0.05). The authors concluded that the
Ortho CMC Push Brace provides the greatest hand functionality.

A soft prefabricated thumb orthosis, combined with exercise, was used by the
intervention group (n=30) in a randomised controlled trial in which the control group
(n=29) carried out an exercise programme only (Hermann et al 2014). This Norwegian
study identified an immediate positive impact on pain during grip (significant for three
pain measures) when wearing the orthosis, but no sustained general effect when not
worn. A trend towards an increase in pinch grip was identified but, unlike some of the
other studies, Hermann et al found that grip was decreased when the orthosis was
worn. Function was self-reported and participants described a range of activities during
which they had worn the orthosis, from resting or sleeping to driving and writing by
hand. Satisfaction with the orthosis design was mixed, with additional support for the
carpometacarpal joint being identified as needed by 11 participants in the intervention

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Recommendations and supporting evidence

group. A total of 82% (n=23) stated that they would, however, continue to use the
orthosis after the study.

Maddali-Bongi et al (2014) used a cohort study to evaluate the use of an orthosis for
individuals with symptomatic thumb carpometacarpal joint osteoarthritis. The focus was
on pain, grip and pinch strength and hand disability, and participants were manual
workers (n=27) and non-manual workers (n=23) in Italy. All participants had a ‘butterfly’
thermoplastic short opponens custom-made orthosis, and additionally received an
educational programme of two sessions (two hours each).

Pain was significantly reduced at 30 days post-intervention in both groups, and this was
maintained at the 12-month follow-up point. Manual and non-manual workers had
significant improvements in grip and pinch strength at 30 days; hand function and ability
improved in the whole group, and in manual workers, but was not significant in non-
manual workers. During the 30-day period the wearing regimen was 16 hours a day;
during the follow-up period the orthosis was intended to be worn only as required, on
pain exacerbation. The findings add to the evidence that pain relief can be gained from
use of an orthosis for thumb base osteoarthritis, but it should be noted that an
education programme (which included ergonomic principles about how to prevent
thumb carpometacarpal overuse) was also a part of this intervention.

Bani et al’s (2013a) cohort study, undertaken in Iran, involved 18 participants with
osteoarthritis and pain in the base of the thumb. A custom-made low-temperature
mouldable thermoplastic orthosis was worn for 90 days and measures were completed
at baseline, 30, 60 and 90 days. A significant improvement was detected in pain scores
after 30 days of wearing. Grip, pinch and function also improved significantly after 90
days of wearing the orthosis.

A comparison of a prefabricated neoprene splint and custom-made thumb splint for


first carpometacarpal joint osteoarthritis was carried out by Bani et al (2013b) in a small
randomised cross-over trial involving 35 participants. Splints were worn during routine
activities of daily living for four weeks with a two-week washout before changing over,
while a control group did not wear a splint. The evaluation demonstrated a significant
improvement in pain, function and pinch compared with baseline and the control group.
Grip strength changes were positive but not significant. The custom-made splint was
found to give better results in terms of pain reduction, but there was no significant
difference between the two orthoses for any of the other measures.

The comparison between a prefabricated neoprene orthosis and custom-made thumb


orthosis was the subject of a study by Becker et al (2013). One hundred and nineteen
individuals were randomised. Sixty-two participants completed the trial, having worn
one of the two orthoses over a period of 5–15 weeks for daily activities, and at night if
wanted. Pain, grip and pinch strength were found to improve with both orthoses, but
there was no change in arm-specific hand function, as measured by the Disabilities of
the Arm, Shoulder and Hand (DASH) questionnaire. The only significant difference
between the two orthoses was in relation to comfort, with the prefabricated neoprene
orthosis being preferred.

Kjeken et al (2011a) examined the use of an orthosis, but as part of a broader assistive
technology intervention which included other small devices to assist with personal care,
housework and leisure activities (e.g. ergonomic handles). The focus of this three-month
Norwegian randomised controlled trial (n=70) was the primary outcome of occupational
performance and satisfaction using the COPM. Secondary measures included the
Australian/Canadian (AUSCAN) Osteoarthritis Hand Index, and pain and fatigue. A total

­30 Hand and wrist orthoses for adults with rheumatological conditions
Recommendations and supporting evidence

of 26 of the 35 participants in the assistive technology group received an orthosis,


although no additional information was provided about design or wearing regimen.
COPM scores identified a significant positive change in performance and satisfaction
scores in the assistive technology group at three months, and there was also significant
improvement for the AUSCAN hand function score. There was minimal but non-
significant improvement reported for other secondary outcomes measured, including
pain. The contributory impact of thumb orthoses cannot be isolated or identified within
this study, but it does provide some indicative contributory evidence of improvement on
function.

A systematic review was undertaken by Kjeken et al (2011b) which considered the


effect of orthoses and exercise programmes, separately and combined, on hand
osteoarthritis. Nine studies were identified which involved orthoses, two with low risk of
bias. Meta-analysis demonstrated that an orthosis (for thumb support) significantly
reduced hand pain, but there was no consensus on when it would be most usefully
worn. Subluxation could also be reduced, but whereas improvement in function and
pain could be amplified with a prefabricated semi-rigid orthosis, a rigid orthosis gave
better effect for subluxation. The review also identified that combining an orthosis and
daily exercises may reduce pain and stiffness, and improve function.

A comparison of two orthoses, a prefabricated neoprene Comfort Cool® orthosis and a


custom-made thermoplastic hybrid orthosis (1.6 mm Rolyan® Aquaplast Watercolors),
was conducted using a cross-over trial in Canada (Sillem et al 2011). Participants (n=56)
were randomly allocated to one of the orthoses, which was worn at night for four weeks,
prior to a two-week washout period and a change to the alternative orthosis. The
improvements in pinch and grip were minimal and had an equivalent effect between the
two orthoses. Pain and function were improved by the use of either orthosis, although
the hybrid orthosis reached statistical significance in the change from baseline and
achieved a greater treatment effect on pain reduction.

The use of a functional orthosis for osteoarthritis of the thumb carpometacarpal joint
was investigated in a Brazilian randomised controlled trial (Gomes Carreira et al 2010)
in which an orthosis was provided for all participants (n=40). The intervention group was
given the orthosis for the full 180 days of the study for activities of daily living and work
activities, whereas the control group was given the orthosis only from days 90–180. Pain
was improved in both groups, but the intervention group experienced improvement as
early as 45 days, which was maintained throughout. The control group experienced
improvement only once they started using the orthosis. The study found, however, that
the orthosis had minimal impact on functional capacity and did not alter grip strength,
pinch strength or dexterity.

Boustedt et al’s (2009) randomised controlled trial (n=40) investigated the impact of an
orthosis and exercise when added to a standard joint protection programme for
individuals with thumb base osteoarthritis. They participated in a joint protection
programme consisting of group educational/behavioural sessions, trying out grip
assistive devices and an elastic thumb orthosis during the day at clinic and home and,
during the session, paraffin wax heat treatment and hand exercise with paraffin dough.
In the orthosis and exercise intervention group two different orthoses were worn by the
20 female participants: a custom-made thermoplastic forearm orthosis worn at night,
and a prefabricated elastic thumb orthosis and/or custom-made thermoplastic thumb
orthosis worn at all times during the day. Hand exercise was also performed at home.
The control consisted of the joint protection programme only.

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Recommendations and supporting evidence

Measures were taken at baseline, one week after the five-week joint protection
programme, and at one-year follow-up. The analysis identified that, compared with the
control group, the participants in the intervention group had a significant decrease in
pain and stiffness, and an improvement in daily activities, directly after the intervention
and at one-year follow-up. Grip force also improved in the intervention group, but this
was not significantly different from the control group.

Moe et al’s (2009) systematic review included other systematic reviews to summarise
the evidence on the effectiveness of non-pharmacological and non-surgical
interventions for hand osteoarthritis. Orthoses were included in three of the four
reviews that met the inclusion criteria. The overarching view was that there was
evidence, albeit limited, for the use of an orthosis to reduce pain, but no
recommendation on design or materials could be made due to the absence of sufficient
evidence.

A randomised controlled trial conducted in France aimed to examine the provision of a


night-time custom-made neoprene orthosis on thumb base osteoarthritis (Rannou et al
2009). All participants in the intervention group (57) were fitted with an orthosis by an
occupational therapist, while the control group (n=55) received the usual care (not
defined). A statistically and clinically significant change was determined for the reduction
of pain, reduction in disability (Cochin Hand Function Scale) and participant-perceived
disability at 12 months. While there was some improvement at one month, this was not
significant. Concordance and satisfaction were high, and no adverse effects were
reported.

A systematic review (Egan and Brousseau 2007) examined the evidence on the
effectiveness of orthoses for carpometacarpal osteoarthritis. The review identified some
evidence for the use of an orthosis, not only for its potential positive impact on pain
relief but in reducing subluxation on pinch in participants with early osteoarthritis. This
study focused on the clinical implications for occupational therapists emerging from the
evidence. While agreeing with other studies that there is a lack of superiority with
respect to orthosis design, the authors considered that wearing an orthosis at least for
painful or heavy activities, and for longer periods during the day and at night for an
initial period of 3–4 weeks, may be beneficial. Encouraging the use of an orthosis during
activities promoting carpometacarpal subluxation for individuals with Stages I and II
osteoarthritis was also suggested.

Wajon and Ada (2005) compared two different orthosis and exercise regimens in their
randomised controlled trial. A custom-made thermoplastic strap orthosis was worn by
the intervention group (n=19) for two weeks, followed by a further four-week period
with the addition of abduction exercises. The control group (n=21) wore a short
opponens thumb orthosis and after their two-week period continued to wear the
orthosis but began a pinch grip exercise regimen. In both groups the orthosis was to be
worn full time and removed only for personal hygiene. Outcomes measured were pain,
pinch strength and hand function (Sollerman Test of Hand Function). While
improvements were recorded for both groups, neither intervention was superior to the
other.

A comparative cross-over randomised trial was undertaken by Weiss et al (2004)


comparing the effect of a prefabricated neoprene orthosis and a custom-made
thermoplastic orthosis. The treatment was short, with participants asked to wear the
first orthosis for one week immediately followed by wearing the second orthosis. There
was no washout period included. Both orthoses were effective at relieving pain, allowing

­32 Hand and wrist orthoses for adults with rheumatological conditions
Recommendations and supporting evidence

function and reducing subluxation, but participants preferred the prefabricated


neoprene orthosis, and the effects on pain, function and pinch pain were superior.

Evidence overview
A number of studies have been undertaken to explore the impact of orthoses on the
symptoms of base of thumb osteoarthritis. The studies, while not all high quality,
frequently considered pain as the primary outcome measure, with function, grip and
pinch strength often as secondary outcome measures.

The evidence that orthoses have an impact on pain has been consistent in terms of
direction of the outcomes, with an improvement being reported in 17 of the 19
studies described (9 of those statistically significant). Only 1 study identified no
change in pain. The impact of an orthosis on function was considered in 13 studies,
6 of which (46%) were statistically significant in favour of an improvement in
function, with 1 identifying no change. Risks or adverse outcomes associated with
these orthoses were rarely reported in the studies.

Changes in grip and pinch strength outcomes have been less consistent, with two
studies identifying a decrease in grip, and statistical significance being rare for both
measures.

5.3 Optimising outcomes of people who access services


Optimising outcomes of people who access services
6. It is recommended that validated, standardised assessment and outcome 1A
measures are used pre- and post-provision of an orthosis to monitor
progress and evaluate effectiveness. Measures may include assessing
functional outcomes, understanding individual satisfaction and utilising
Patient Reported Experience Measures (PREMs).
(Duong et al 2018 [D]; Healy et al 2018 [B]; Aebischer et al 2016 [B]; Hammond
et al 2016 [C]; Bertozzi et al 2015 [B]; Bani et al 2014 [C]; Hermann et al 2014
[B]; Maddali-Bongi et al 2014 [C]; Nasir et al 2014 [C]; Bani et al 2013a [C];
Bani et al 2013b [A]; Kjeken et al 2011a [A]; Sillem et al 2011 [B]; Gomes
Carreira et al 2010 [B]; Boustedt et al 2009 [C]; Giesen et al 2009 [C]; Rannou
et al 2009 [A]; Boer et al 2008 [C]; Silva et al 2008 [A]; Veehof et al 2008a [B];
Pagnotta et al 2005 [C]; Wajon and Ada 2005 [A]; Haskett et al 2004 [B]; Weiss
et al 2004 [C]; Zijlstra et al 2004 [C])
[Statement amended and new evidence 2020]
7. It is suggested that, given the inconsistent evidence of a superior orthosis 2A
fabrication/design or wearing regimen, the orthosis selected should
maximise occupational performance and individual choice.
(Cantero-Téllez et al 2018 [B]; Almeida et al 2017 [B]; Vegt et al 2017 [B];
Bertozzi et al 2015 [B]; Spaans et al 2015 [B]; Nasir et al 2014 [C]; Bani et al
2013b [A]; Becker et al 2013 [B]; Sillem et al 2011 [B]; Giesen et al 2009 [C];
Thiele et al 2009 [C]; Wajon and Ada 2005 [A]; Haskett et al 2004 [B]; Weiss et
al 2004 [C])
[New evidence 2020]

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Recommendations and supporting evidence

8. It is recommended that to optimise adherence to wearing a prescribed 1C


orthosis, the occupational therapist should discuss with the person the
potential benefits and limitations; practicalities of use and comfort;
provide the opportunity to try on orthoses prior to issue; and routinely
arrange follow-up review of the intervention.
(Tada et al 2018 [D]; Almeida et al 2017 [B]; Shankland et al 2017 [C]; Nasir et
al 2014 [C]; Boer et al 2008 [C]; Gooberman-Hill et al 2013 [D]; Veehof et al
2008b [C]; Pagnotta et al 2005 [C]; McKee and Rivard 2004 [D])
[New evidence 2020]

Occupational therapists, working in partnership with people with rheumatological


conditions, should evaluate the effectiveness of their intervention. This means ensuring
that appropriate standardised assessment tools are used as a baseline from which
change can be measured; seeking the views of individuals regarding the effectiveness of
their intervention; and documenting the process and results of assessments and
interventions. Standardised outcome measures should be used to provide credible and
reliable justification for the intervention that is delivered and to ensure that what is
recorded is measured objectively with as little error as possible, and the highest level of
reliability and validity.

The principle of involving the public and people who access services in research, and the
full engagement of individuals in their assessment and treatment, is essential in
individually focused interventions. The involvement of people who access services is
integral to an intervention such as orthotics, where concordance is ultimately within the
person’s control.

This section describes evidence from studies that included participants with either
rheumatoid arthritis or osteoarthritis. The recommendations for optimising outcomes
for people who access services provide overarching principles that can be considered as
part of the prescription of any hand or wrist orthosis for adults with rheumatological
conditions.

5.3.1 Measuring outcomes

Optimising outcomes of people who access services


6. It is recommended that validated, standardised assessment and outcome 1A
measures are used pre- and post-provision of an orthosis to monitor
progress and evaluate effectiveness. Measures may include assessing
functional outcomes, understanding individual satisfaction and utilising
Patient Reported Experience Measures (PREMs).
(Duong et al 2018 [D]; Healy et al 2018 [B]; Aebischer et al 2016 [B]; Hammond
et al 2016 [C]; Bertozzi et al 2015 [B]; Bani et al 2014 [C]; Hermann et al 2014
[B]; Maddali-Bongi et al 2014 [C]; Nasir et al 2014 [C]; Bani et al 2013a [C];
Bani et al 2013b [A]; Kjeken et al 2011a [A]; Sillem et al 2011 [B]; Gomes
Carreira et al 2010 [B]; Boustedt et al 2009 [C]; Giesen et al 2009 [C]; Rannou
et al 2009 [A]; Boer et al 2008 [C]; Silva et al 2008 [A]; Veehof et al 2008a [B];
Pagnotta et al 2005 [C]; Wajon and Ada 2005 [A]; Haskett et al 2004 [B]; Weiss
et al 2004 [C]; Zijlstra et al 2004 [C])
[Statement amended and new evidence 2020]

­34 Hand and wrist orthoses for adults with rheumatological conditions
Recommendations and supporting evidence

A range of assessments and outcome measures has been used within the appraised
primary research and, where validated for use with the guideline population, these may
also be applicable to practice.

The key primary and secondary outcomes reported in the evidence supporting this
guideline were pain, function, grip and pinch strength. Self-report measures were
frequently used for pain and function, with some objective measures, mostly for grip
and pinch strength.

Pain intensity was self-reported most frequently using a visual analogue scale (VAS) or
the Numeric Rating Scale for Pain (NRS Pain). The VAS consists of a single line, usually
100 millimetres (mm) in length, against which the participant makes a line perpendicular
to the 100 mm line to reflect their intensity of pain. Pain is normally what is currently
being experienced or which has been experienced over a specified time period, such as
the past 24 hours. A score of 0 refers to no pain, with a score of 100 referring to the
worst pain imaginable (Bani et al 2014, Bani et al 2013a, Bani et al 2013b, Boustedt
et al 2009, Boer et al 2008, Gomes Carreira et al 2010, Haskett et al 2004, Kjeken et
al 2011a, Pagnotta et al 2005, Rannou et al 2009, Silva et al 2008, Veehof et al
2008a, Wajon and Ada 2005, Weiss et al 2004). The NRS Pain is a comparable measure
using a single 11-point numeric scale in which the participant self-reports a whole
number (0–10) that reflects the intensity of pain (Hermann et al 2014, Maddali-Bongi
et al 2014).

“I am 79 – all my working life I was a draughtsman and the ‘splints’ did help reduce pain.”
Person who accessed services – consultation feedback

The Disabilities of the Arm Shoulder and Hand (DASH) questionnaire (Hudak et al 1996)
was used in a number of the research studies to measure upper limb function (Bani et
al 2014, Bani et al 2013a, Bani et al 2013b, Boustedt et al 2009, Gomes Carreira et al
2010, Silva et al 2008, Veehof et al 2008a). The DASH is a self-report questionnaire of
physical function, symptoms, confidence and social participation relating to conditions
affecting any part of the upper extremity. It assesses overall upper limb function
(bilateral), irrespective of the hand affected, and consists of 30 items, 24 of which are
focused on function, including fine motor hand functions. There are optional additional
modules relating to paid or unpaid work and to performance of a sport or playing a
musical instrument. The scoring of items is on a Likert scale of 1 (no difficulty) to 5
(unable to do), with an algorithm transforming the score to a range from 1 to 100, with a
higher score indicating greater disability.

The method used in two studies (Kjeken et al 2011a, Sillem et al 2011) to measure
function was the Australian/Canadian Osteoarthritis Hand Index (AUSCAN) (Bellamy et al
2002). Again a self-reported measure of overall hand function, this measure has three
scales to assess hand pain, stiffness and hand function where there is the presence of
osteoarthritis.

An objective measure of bilateral dexterity used in three studies included in the


evidence (Giesen et al 2009, Veehof et al 2008a, Zijlstra et al 2004) was the Sequential
Occupational Dexterity Assessment (SODA) (Lankveld et al 1996). The SODA, designed to
measure hand function in rheumatoid arthritis, consists of standardised hand-related
daily activities that are assessed in terms of ability to perform the tasks; a higher score
indicates better hand function.

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Recommendations and supporting evidence

The measurement of grip and pinch strength generally involved a dynamometer and
pinch gauge, using recognised standardised measurement tools such as the Jamar®
Hydraulic Hand Dynamometer.

A number of systematic reviews further support the use of validated, standardised


assessments and outcome measures to monitor progress and effectiveness (Duong et
al 2018; Healy et al 2018; Aebischer et al 2016; Hammond et al 2016; Bertozzi et al
2015; Nasir et al 2014). The authors noted the difficulty in comparing research evidence
because of a lack of standardised assessments and outcome measures and the wide
variety of assessments and measures used.

Evidence overview
The evidence across the studies indicated that pain and function outcomes can be
determined using self-reported measures such as the VAS or NRS for pain, and the
DASH or AUSCAN for function. Measures can also be used to objectively determine
performance for dexterity, grip and pinch strength. The combination of subjective
(self-reported) and objective performance measures can provide reliable, valid and
responsive information about the outcomes of orthotic intervention, and can
contribute to evidence of effectiveness. This would greatly increase the comparability
within systematic reviews of the evidence around orthoses.

5.3.2 Orthosis design and wearing regimen

Optimising outcomes for people accessing services


7. It is suggested that, given the inconsistent evidence of a superior orthosis 2A
fabrication/design or wearing regimen, the orthosis selected should
maximise occupational performance and individual choice.
(Cantero-Téllez et al 2018 [B]; Almeida et al 2017 [B]; Vegt et al 2017 [B];
Spaans et al 2015 [B]; Bani et al 2013b [A]; Becker et al 2013 [B]; Sillem et al
2011 [B]; Giesen et al 2009 [C]; Thiele et al 2009 [C]; Wajon and Ada 2005 [A];
Haskett et al 2004 [B]; Weiss et al 2004 [C])
[New evidence 2020]

Research into the effectiveness of one orthosis design compared to another has been
the focus of a number of studies, as reported in the evidence on orthoses for
rheumatoid arthritis and for osteoarthritis.

Cantero-Téllez et al (2018) compared two orthoses for thumb carpometacarpal


osteoarthritis, one that immobilised the metacarpophalangeal joint and one that did
not. Overall, no difference was found between the design of the two orthoses in terms
of pain reduction and improved hand function. Bani et al (2013b) also investigated
orthoses for osteoarthritis. The custom-made orthosis was found to give better results
in terms of pain reduction, but there was no significant difference between that and the
neoprene orthosis on any other measures. Orthoses were worn for routine activities of
daily living for four weeks. Similarly, Vegt et al’s (2017) study found varying results, with
participants reporting less pain and better key grip strength with an off-the-shelf design
that immobilised the carpometacarpal joint compared with a custom-made design that
immobilised both the carpometacarpal and metacarpophalangeal joints. However, the

­36 Hand and wrist orthoses for adults with rheumatological conditions
Recommendations and supporting evidence

study found that hand function improved significantly with the custom-made design
(p<0.001).

Additionally, in Vegt et al (2017) participants reported which orthosis they preferred.


Two-thirds (68%) preferred the off-the-shelf orthosis, 13% the custom-made orthosis
and 19% said they were satisfied with either.

A literature review by Almeida et al (2017) investigated differences in orthoses design


and found inconclusive evidence to recommend any one particular design. Four studies
did not show significant differences in pain reduction; two studies found significant pain
reduction with a custom-made design only involving the carpometacarpal joint
compared with a prefabricated neoprene design; one study showed better pain
reduction with a prefabricated neoprene design compared with a rigid thermoplastic
design. Inconclusive results were also found in a systematic review of orthoses for
thumb base osteoarthritis by Spaans et al (2015). Of six randomised controlled trials
comparing different orthoses, two studies found that a custom-made orthosis reduced
pain significantly more than a prefabricated design, but all other randomised controlled
trials found no evidence of a superior design.

Becker et al (2013) compared a prefabricated neoprene orthosis and custom-made


thumb orthosis worn for daily activities and at night if wanted, over a period of 5–15
weeks. The only significant difference between the two orthoses was in relation to
comfort, with the prefabricated neoprene orthosis being preferred. A greater effect on
pain reduction was evidenced in a custom-made thermoplastic hybrid orthosis
compared with a prefabricated neoprene orthosis, worn at night for four weeks, in
Sillem et al’s (2011) study. Wajon and Ada’s (2005) randomised controlled trial,
however, found neither a custom-made thermoplastic strap orthosis (plus abduction
exercises) nor a short opponens thumb orthosis (plus pinch exercise) was superior to
the other. Orthoses were worn for a total of six weeks full time. Weiss et al (2004)
compared a prefabricated neoprene orthosis with a custom-made thermoplastic
orthosis worn for a one-week period in a cross-over trial; participants preferred the
prefabricated neoprene orthosis, and the effects on pain, function and pinch pain were
superior.

Studies comparing orthosis design for rheumatoid arthritis included two investigations
comparing leather wrist splints with one or more other prefabricated wrist orthoses. The
superiority of the leather wrist orthosis (not commonly available in the UK) for pain relief
was found by both Thiele et al (2009) and Haskett et al (2004), though Haskett et al
concluded that the difference compared with the other orthosis was not significant
enough to warrant the cost of the custom-made leather orthosis. The intervention
period for Thiele et al’s study was two weeks (wearing regimen not specified), and for
Haskett et al’s study an orthosis was worn for four weeks for activities during the day
that caused pain or discomfort.

Orthosis design for swan neck deformity was compared by Giesen et al (2009) for a
silver ring splint and a commercial thermoplastic orthosis. Participants found both
orthoses to be acceptable but preferred the silver ring splint, while the researchers said
given both were comparably effective orthoses, the prescription could be based on
individual choice or cost.

Wearing regimens, as identified within the evidence for rheumatoid arthritis and
osteoarthritis, have been highly variable (see evidence tables in Appendix 6). These have
covered a wide range of time periods for wearing, and guidance on when to wear the
orthosis (for example, during the day, at night, or for activities).

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Recommendations and supporting evidence

Evidence overview
A wide range of prefabricated orthoses is available commercially; others are custom-
made. These may be fabricated from a variety of materials, including thermoplastics,
neoprene, leather and hybrid combinations. Research studies have compared a
number of these orthoses, for both osteoarthritis and rheumatoid arthritis. While
some orthoses showed a greater effect on pain reduction, and others were preferred
by participants, there is no consistent evidence of a superior orthosis design.
Furthermore, the variance of wearing regimen is particularly evident within the
evidence.

5.3.3 Experiences of people who access services

Optimising outcomes of people who access services


8. It is recommended that to optimise adherence to wearing a prescribed 1C
orthosis, the occupational therapist should discuss with the person the
potential benefits and limitations; practicalities of use and comfort;
provide the opportunity to try on orthoses prior to issue; and routinely
arrange follow-up review of the intervention.
(Tada et al 2018 [D]; Almeida et al 2017 [B]; Shankland et al 2017 [C]; Nasir et
al 2014 [C]; Boer et al 2008 [C]; Gooberman-Hill et al 2013 [D]; Veehof et al
2008b [C]; Pagnotta et al 2005 [C]; McKee and Rivard 2004 [D])
[New evidence 2020]

A prospective study by Tada et al (2018) attempted to design an effective, attractive and


easy-to-wear splint. It found that the splint was not only effective at reducing pain;
participants reported satisfaction related to usability of 8.9 (±0.3) out of 10 and
satisfaction with appearance 7.6 (±0.4) out of 10.

Almeida et al’s (2017) literature review noted that because there is not enough
evidence to recommend a specific orthosis design, the choice of orthosis should be
based on the occupations and activities of daily living of the person. The authors
recommended that future studies should keep a client-centred perspective while
examining the impact of the orthosis on the person’s goals, their performance while
wearing the orthosis, and whether they follow the clinician’s recommendations.

Shankland et al (2017) investigated reasons for not wearing an orthosis, and found the
most common reasons were: food hygiene issues, the orthosis making the hand too hot,
or finding the orthosis too rigid. Some said a reduction in pain levels meant they did not
feel the need to wear the orthosis.

A systematic review of eight articles considering compression gloves by Nasir et al


(2014) highlighted the need for consultation with the person about comfort and fit in
order to help with the wearing regime. This review noted that comfort and fit are
important to encourage motivation to wear the gloves regularly, and may influence
outcomes such as hand function.

Gooberman-Hill et al (2013) involved people who had a diagnosis of arthritis in the


design of a proposed future clinical trial evaluating orthoses for thumb base

­38 Hand and wrist orthoses for adults with rheumatological conditions
Recommendations and supporting evidence

osteoarthritis. Eight participants from two sites in the UK were engaged in interactive
discussion fora to discuss their experiences of osteoarthritis and of their own thumb
orthosis; to try on and evaluate a number of alternative orthoses; to express their views
on the acceptability of a placebo arm in a future trial; and to consider the acceptable
and unacceptable design features for the proposed placebo orthosis with a focus on
wearability and support.

“Consideration should be given to including the evaluation of ease of use, comfort and
acceptable appearance. Collating information from patients for all areas will improve
[the] evidence base.”
Person who accessed services – consultation feedback

The evaluation of their existing orthoses highlighted some key factors from their own
experiences, such as neoprene is too hot in summer; the beige colour is too medical and
not practical; dislike of hard plastic moulded orthoses; hook and loop fastenings easy to
don/doff but catch on clothing; concerns about washing orthoses; and stigma about
wearing an orthosis, as it makes disability obvious. An important factor highlighted was
that an orthosis should offer support in painful areas and immobilisation, and
conversely that a placebo orthosis should not offer any ‘real’ support for the joint at the
base of the thumb. This study provided perspectives on the characteristics and
experiences of wearing an orthosis by the people who wore them. These may offer the
occupational therapist insight into the treatment burden associated with orthotic
intervention, and inform their consideration of how the process of service delivery can
positively impact on adoption of the orthosis.

“I have had splints now for 30 years. This week, while enquiring about boots to be made, I
found out that there are not only beige wrist splints but black as well. There is no cost
difference but because more people want beige there is no choice. I would have gladly
worn black in my younger years, and intend to ask if I can get it next time. Not all people
are able to accept orthosis, but if there is no extra cost incurred, could we have a little
choice?”
Person who accessed services – consultation feedback

Boer et al (2008) examined the possession and use of a functional wrist orthosis in a
Dutch population with rheumatoid arthritis (n=240). The multicentre cross-sectional
study identified, from interviews and questionnaires, that the main reasons for using an
orthosis were for relief of pain and joint protection. Use was significantly associated with
the presence of wrist and hand complaints, worse physical functioning and greater
satisfaction with comfort. A large proportion of participants had not, however, been
wearing their orthosis in the three months prior to the study; 42% (n=54) had not used
the orthosis at all. Reasons for non-use included a perception there was no need,
difficulties with comfort or fit, and perceived harmful effect. This study highlights the
importance of the active engagement of the person in the prescription of an orthosis.

The usage of functional wrist orthoses was also explored via semi-structured interviews
in a Dutch qualitative study involving 18 participants with rheumatoid arthritis (Veehof
et al 2008b). This research aimed to gain insight into participants’ motivations for, and
perceived barriers to, wearing an orthosis.

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Recommendations and supporting evidence

Orthosis use was found to be dependent on symptoms and their seriousness, notably
pain, swelling or tingling feelings. Reducing those symptoms, and the provision of
support or immobilisation of the wrist, were reported to be important reasons for
orthosis wear. A decrease in functional ability, activities that were wet or dirty, and other
reasons such as poor comfort and fit were identified as some of the potential barriers to
wearing an orthosis. The study highlighted the importance of the individual person’s
perceived benefits and barriers in influencing concordance to orthotic prescription. An
outcome of the study was a list of strategies to increase fidelity to wearing regimens.

“I suspect I am no different to many service users in wanting to know what are the
benefits and potential risks of any intervention to me personally. Therefore from a service
user’s perspective I would suggest that strengthening or highlighting the perceived benefit
of the recommendation to the user is fundamental in achieving compliance.”
Person who accessed services – consultation feedback

Pagnotta et al (2005) identified that most participants did not use the orthosis for their
daily activities, commenting that the orthosis got in the way and was ‘cumbersome’.
When they did use it, the primary purpose was for pain management. This finding
emphasises the importance of the occupational therapist considering treatment burden
and discussing with the person their individual occupational performance needs and
activities, to ensure that the prescription of an orthosis and daily wearing regimen
‘maximises benefit and minimises inconvenience’.

The application of a client-centred occupation-based framework for orthotic intervention


was the focus of a case studies report by McKee and Rivard (2004). Three case studies
were reported, two of which concerned individuals with hand osteoarthritis. The
Canadian Model of Occupational Performance underpinned the intervention approach,
with satisfaction and performance measured by the Canadian Occupational
Performance Measure (COPM). The importance of six factors was delineated – client-
centredness; orthosis comfort; cosmesis; convenience; ‘less is more’ orthosis design; and
follow-up – indicating that these must equally be considered as well as efficacy, for
example in improving pain. An ‘interactive consultation process and a collaborative
approach’ can maximise the success of the person’s outcomes.

“I would also say that the patient has to be ready to accept there is a problem and, while
not a magic wand, something might be improved. I would think, though, that provision
for follow-up appointment(s) would be advised to check for compliance.”
Person who accessed services – consultation feedback

­40 Hand and wrist orthoses for adults with rheumatological conditions
Recommendations and supporting evidence

Evidence overview
Research that involves the perspectives of people who access services can provide a
richness which, when taken into account, can have the potential to enhance wearing
of an orthosis in practice and, as such, can improve the outcomes sought by the
individual. Views expressed that were common to the studies included the
importance of the support provided by the orthosis, its comfort and appearance, and
ease of use, with ‘perceived need’ being a key driver for deciding to wear the
orthosis.

The range of potential issues influencing wearing of an orthosis implies that


follow-up review of an orthosis is necessary to enable these to be addressed.

Orthoses that are worn regularly are more likely to result in effective outcomes for
those who wear them and, by association, more efficient use of occupational therapy
service resources.

5.4 Potential impact of the recommendations


5.4.1 Desired outcomes

1. Perspectives of people who access services on the benefits of wearing an orthosis.


2. Measurable effectiveness determined by benefits and outcomes, which may include:
• Reduced pain.
• Improved grip.
• Improved pinch strength.
• Improved function.
• Improved dexterity.

5.4.2 Risk management


A comprehensive assessment
The evidence reviewed did not indicate when it might be inappropriate to prescribe an
orthosis; however, the prescription of any orthosis must be based on a comprehensive
assessment, taking into account the nature of the individual’s clinical condition – that is,
‘the underlying disease process and the possible associated hand impairment and
functional limitations’ (Bradley and Adams 2013, p203) and their occupational
performance needs. The individual’s general medical status may also impact on orthosis
prescription: for example, a person with diabetes may have less tolerance for an
orthosis due to impaired sensation or circulatory impairment. Cognitive ability should
also be considered, including the person’s capacity for understanding how to use the
orthosis correctly and how to recognise and respond to discomfort or other indications
of possible adverse effects in a timely and appropriate manner.

An orthosis as part of a comprehensive intervention programme


The potential impact of an orthosis in the re-direction of force to other joints
unconstrained within the orthosis, especially if they are also affected by the underlying
pathology, must also be taken into account. Orthoses should not, therefore, be
considered in isolation. A more comprehensive occupational therapy programme,

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Recommendations and supporting evidence

including joint protection techniques and education, may be required (Bradley and
Adams 2013, p192).

Appropriate orthosis assessment and fitting


The provision and fitting of an orthosis is a specific skill which requires clinical expertise
with respect to anatomy and biomechanics of the wrist and hand. To optimise user
concordance and functionality, there is a need for appropriate assessment and fitting.
An inappropriately selected and fitted orthosis may be ineffectual and increase the risks.
Individuals who may benefit from an orthosis should therefore be referred to an
appropriately trained health professional.

In the context of prescribing an orthosis, factors such as skin condition, correct fitting
and environment where the orthosis will be used (particularly in relation to
environmental or work hazards) all need to be part of the decision-making process.

Monitoring for side effects


Clinical reasoning is essential to determine the balance of expected outcomes with
potential risks or possible adverse effects. This is particularly important given that the
nature of the evidence does not support routine provision, and non-concordance with a
prescribed wearing regimen was reported in a number of the studies included in the
evidence.

Adverse outcomes from orthotic prescription/use were minimal in the studies reviewed,
but orthoses were not without side effects, as reported by people who wore them.
Potential side effects should, therefore, be discussed with the person and monitored
during the period of intervention.

The person’s perspectives established in one functional wrist orthosis study, for
example, made reference to side effects: unpleasant feelings such as tingling, or
pressure points due to tight fit (Veehof et al 2008b). The importance of reducing any
risks was identified in the study, which stated that orthosis use should be reviewed one
week after prescription to evaluate the perceived benefits and barriers to orthosis
wearing, including comfort, fit and concordance.

Silver ring splints and Oval-8® orthoses may have side effects for some individuals
(intolerance of the orthosis, pressure of the orthosis on bony edges, rheumatoid
nodules and paraesthesia), and the risk of these should be discussed with the person
and carefully assessed and monitored following orthotic prescription (Giesen et al 2010,
Zijlstra et al 2004).

Other considerations
Additional considerations which were not necessarily identified within the evidence, but
which should be taken into account, are the durability of an orthosis over time, and the
responsibility of maintenance and replacement of an orthosis in the long term,
particularly if the person is no longer being seen for review or has been discharged from
the service.

5.4.3 Generalisability
The studies conducted on orthoses were heterogeneous, with variations in sample
populations and in the nature of an individual orthosis, its wearing regimen and
concurrent treatments and interventions. This variation has been taken into account in
the development of the recommendations, to ensure that findings have not been over-
generalised.

­42 Hand and wrist orthoses for adults with rheumatological conditions
Recommendations and supporting evidence

The studies have reflected the core population affected by arthritis; that is, there is a
higher prevalence in people aged 45 years and over and in women generally, and the
studies can therefore, in the main, be applied to the guideline population.

5.4.4 Social determinants of health


Occupational therapists need to consider the accessibility of self-reported outcome
measures so that these are inclusive for those with differing literacy levels.

It is good practice to not only discuss but also provide accessible, easy-to-understand,
clearly written information and instructions (including therapist contact details) as part
of the provision of an orthosis. If possible, the inclusion of photographs or clear
illustrations may be helpful.

Difficulty experienced in the ability to put on and take off an orthosis is a factor which
may contribute to poor use and outcomes. People who live alone may have difficulty
managing this, and this must therefore be considered in terms of the orthosis design
and wearing regimen, and where there is bilateral presentation.

The financial circumstances of a person may have an impact on choice. Silver ring
splints, for example, are not routinely available via NHS providers. Preference, therefore,
for a silver ring splint rather than a thermoplastic commercial figure-of-eight ring
orthosis may only be available for those who can afford to self-purchase. This may
disadvantage those who cannot afford a silver ring orthosis, which is reported as being a
more cosmetically and psychologically acceptable orthosis.

Royal College of Occupational Therapists 2020


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6 Perspectives of people who
accessed services

The target audience of the full guideline document is primarily occupational therapists
who prescribe orthoses. While of potential interest to people who access services, the
guideline development group acknowledged that it was not written specifically for a lay
audience.

The perspectives of people who access services are integral to the guideline
development and review processes, and involvement took place through consultation
on the draft scope and draft guidelines (see Sections 9.3 and 11.4).

In the first edition, perspectives on the draft guideline were received from five individual
‘experts’ who had accessed services and from Arthritis Care Scotland. They were asked
to take into account and provide views on five consultation questions (designed by the
guideline development group to prompt opinions particularly on benefits, risks and
outcomes), and any other areas they considered pertinent. The responses provided
invaluable insights and comments and led to amendments, and the inclusion of specific
quotes, within this final guideline.

Q1 – Did you find the overview of the evidence useful to refer to when reading the
recommendations?

All six of the respondents felt that the overview sections of the evidence were useful,
although one respondent indicated that not all “service users will have the capacity to do the
intellectual gymnastics required to benefit from the statistical information”.

“Yes, the overview was useful in expanding the reasoning behind the recommendations.”

“Yes, because it legitimises the points and aids understanding of the outcomes in a bigger
setting.”

Q2 – Do you think the recommendations and information take into account both
the benefits and potential risks of an orthosis?

One valuable comment was made that information about risks was more evident for
orthoses for swan neck deformity. The evidence overview in two sections was revisited
and subsequently amended to reflect this observation.

“I really don’t understand ‘potential risks’. Benefits – yes! Risks – don’t wear it!”

“. . .Try to get the therapist to underline that the outcome might not be clear if only
restricted to a two- to four-week review, and maybe underline the longer-term benefits to
the patient. I know from personal experience that it has taken even four to six weeks to
get the full benefit of the splints.”

­44 Hand and wrist orthoses for adults with rheumatological conditions
Perspectives of people who accessed services

Q3 – Do you think these recommendations will help people understand how an


orthosis may assist them?

A specific comment was given on the format of one recommendation, which was
subsequently revisited and revised by the guideline group, but the key theme from the
responses to this question was that the recommendations will help in understanding.
Responses to this question highlighted the importance of face-to-face interaction with
the occupational therapist, and the significance of discussions about the possible
prescription of an orthosis to meet an individual’s needs. This included that explanations
from the occupational therapist should convey their confidence in an orthosis, together
with the pros and cons of wearing an orthosis.

“I think I learned more from the O. [occupational] therapist than from leaflets.”

“If the OT takes time to say that there are proven studies which show some benefits and if
the person has run out of options – pain gels, tablets, hot/cold compresses et al – and
that it might be of use, even if it looks clumsy. It could let patients also understand more
as there are facts to look at.”

Q4 – Do you think the recommendations and information will help people


understand some of the issues an occupational therapist needs to take into
account when deciding if an orthosis may assist a service user?

The guideline was considered as being beneficial, more so for members of the
multidisciplinary team than the target audience.

“I think it will be of greater benefit to other members of the multidisciplinary team and
wider healthcare team members, such as commissioners and purchasers, than actual
service users, as I think the language used is not specifically targeted at the service users.
An overview of the issues written specifically for service users may be beneficial.”

“Yes, but although every orthosis, depending on type, is person-oriented, may the orthosis
be shown/tried on while the problems are discussed? Also gives patient a chance to see if
they can open/close splints unaided or where an alternative way needs to be provided. I
got wrist splints but the design was tweaked a bit, causing me problems as my fingers
were not able to easily open the longer/stronger [replacement] Velcro® strips.”

Q5 – Are the desired outcomes listed important from a service user perspective?

All respondents clearly stated that all the outcomes were important, with some
comments reflecting the importance of the occupational therapist explaining the pros
and cons, and that what was available would assist daily activities.

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­45
Perspectives of people who accessed services

“Yes. I would further suggest that potentially reducing deformity and thereby improving
the appearance of one’s hands is important to service users. Having said that, I
acknowledge that the document is evidence-based and this may not have come out in the
evidence reviewed.”
[Outcomes were identified from the clinical expertise as part of the scope development:
therefore the appearance of hands was added, for clarity, to deformity.]

“Yes, recommendation no. 8 highlights the need to involve the service user in finding what
would suit their particular needs and improve their understanding of the potential
benefits or limitations.”

“The desired outcome list covers the most obvious things that a patient would expect
from using [an] orthosis. There comes a point where you know without the orthosis there
is no longer a functioning joint/limb and then you are ready to accept the need for [an
orthosis] and also try to accept the orthosis’s limitations.”

The consultation form provided two additional sections for any other comments to be
recorded. Some additional points were provided, a number of which have been included
as quotes in Section 5.3. The quote below is valuable in highlighting the importance of
guidelines to the delivery of services.

“Feedback from individuals who have RA [rheumatoid arthritis] confirm that any support
available to maximise function and reduce pain is to be welcomed. These guidelines
should ensure that consideration of the use of orthoses is available to all individuals with
rheumatological conditions.”

­46 Hand and wrist orthoses for adults with rheumatological conditions
7 Implementation of the guideline

This practice guideline aims to help occupational therapists to take the most appropriate
evidence-based action when prescribing an orthosis for a person with a rheumatological
condition.

Familiarity with the revised guideline document will be an important first step for both
individual practitioners and their managers. It is therefore imperative that occupational
therapists and managers working in this clinical area take responsibility for reviewing
the guideline recommendations within the context of their practice.

Bringing the guideline to the attention of colleagues within the multidisciplinary team
and service commissioners should also be a priority.

A further action to facilitate implementation must be for lead therapists to consider the
‘levers’ and ‘barriers’ within their local organisation and culture that may have an impact
on any changes to practice that may be necessary. Section 7.2 identifies potential
barriers that may be applicable, while Section 7.3 describes resources to facilitate
implementation.

7.1 Dissemination and promotion


Awareness and implementation of this revised practice guideline are important if it is to
influence and have an impact on occupational therapy practice.

Following publication, the full practice guideline has been made available to download
freely from the Royal College of Occupational Therapists’ website, and can additionally
be accessed via the Royal College of Occupational Therapists’ Specialist Section – Trauma
and Musculoskeletal Health webpages.

The guideline will be promoted to its key target audience of occupational therapists and
to relevant others using professional networks and publications, and internet and social
media channels.

7.2 Organisational and financial barriers


The recommendations stated within this guideline document are intended to help
occupational therapy staff to contribute effectively to those outcomes important to the
person accessing services, and to the provision of orthoses within occupational therapy
services.

The occupational therapist’s individualised approach, which takes into account the
person, the environment and their occupation (Law et al 1996, Duncan 2011), is an
important facilitator in the effective implementation of the recommendations.

It is recognised, however, that there will be potential barriers, both organisational and
financial, that may influence application of the recommendations. It is important that
occupational therapists take these into account when implementing this guideline. The

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Implementation of the guideline

most likely barriers, described below, were identified via consensus agreement of the
clinical experts in the guideline development group.

The underpinning critical resource required to implement these guideline


recommendations is the inclusion of appropriately trained practitioners within the
multidisciplinary team (NICE 2014a). Commissioners, providers and managers should
ensure that occupational therapists are core team members, giving full recognition to
their contribution to care planning and musculoskeletal health and, thus, the health and
wellbeing of people with rheumatological conditions (Arthritis Research UK 2014).

The use of some standardised assessment and outcome measures may have financial
costs and implications as some, for example the Australian/Canadian Osteoarthritis
Hand Index, are not free to download or use.

The evidence reviewed has not provided definitive guidance about the superiority of
particular designs of orthoses. Choice of design has, however, been identified as one of
the potential factors likely to influence concordance to wearing regimens, with studies
reporting on personal preferences. The therapist should therefore, ideally, be able to
choose the most appropriate orthosis and design, reflecting the clinical and occupational
needs of the individual and, where possible, their preference. There is a wide variety of
commercially available prefabricated orthoses of different designs and fabrics. Where an
orthosis is custom-made, rather than prefabricated, there may be a cost implication for
the necessary equipment, materials and fabrication process, including staff time.

The cost or source of a specific orthosis may be a potential barrier. An occupational


therapist may be limited in choice due to their organisation’s preferred supplier
contracts. As identified in the evaluation, orthoses used in research, such as a leather
functional wrist orthosis (Haskett et al 2004), may not be available to occupational
therapists within UK healthcare provision. Silver ring splint provision, which is likely to
require importation from the supplier in the USA, or links with local jewellers for custom
fabrication, may also prove to be prohibitively expensive or inaccessible and the
occupational therapist may, therefore, only be able to advise and support the individual
to self-purchase.

The feasibility of follow-up appointments within organisational systems and workloads


may create a barrier to the review of an orthosis prescribed. Access to a replacement or
subsequent orthosis may also be subject to financial restrictions.

7.2.1 Cost-effectiveness
The literature search strategy for this guideline included economic and cost-
effectiveness search terms, and the NHS Economic Evaluation Database was included as
a core database.

Despite this, no cost-effectiveness studies or economic evaluations specific to hand and


wrist orthoses were identified in the development or review of the guideline, and the
costs associated with orthoses have not been a feature of most of the studies reviewed
for the guideline.

Two studies used to support the recommendations in this guideline compared the
benefits of two orthoses and considered financial implications alongside the outcomes
of the intervention. In a comparison of three orthoses, Haskett et al (2004) identified
that the most expensive of the three (taking into account the orthosis itself, fitting time
and instructions) was the leather functional wrist orthosis, which demonstrated some

­48 Hand and wrist orthoses for adults with rheumatological conditions
Implementation of the guideline

superiority in terms of degree of pain reduction and participant preference. Clinical


differences alone were not considered significant enough to warrant the prescription of
the more expensive custom-made leather orthosis.

Cost is a potential issue for the prescription of orthoses for swan neck deformity.
Research participants have expressed a preference for silver ring splints compared with
a thermoplastic orthosis, but the effects of both orthoses on dexterity and dexterity-
related pain have been shown to be comparable (Giesen et al 2009).

The implication from those two studies is that the evidence base does not consistently
identify one orthosis as superior to another with respect to effectiveness on key primary
and secondary outcomes. Cost may therefore be a factor that influences decision-
making.

The prescription of an orthosis has not been specifically compared with alternative
treatments in this guideline. In practice, however, an orthosis may be recommended by
commissioners or trusts, prior to other treatments being provided, as a low-cost and
potentially effective option.

7.3 Implementation resources


Three core implementation resources are available to support this practice guideline.

7.3.1 Quick reference and implementation guide


The quick reference and implementation guide is intended to be used by practitioners
as an easily accessible reminder of the recommendations for intervention, and includes
suggestions for implementing them. It should ideally be used once the practitioner has
read the full guideline document. This is important to ensure an appreciation and
understanding of how the recommendations were developed, and their context.

The quick reference and implementation guide includes the following:

• Introduction.
• List of the recommendations, their strength, and the quality of the evidence leading to
their development.
• Policy and service delivery context.
• Background to the clinical condition.
• The occupational therapy role.
• Potential impact of the recommendations.
• Tips for implementing the recommendations.

7.3.2 Audit form


It is recommended that occupational therapists use the Royal College of Occupational
Therapists’ audit tool that supports this guideline.

The audit form for this guideline provides a standard template for individual
occupational therapists or services to audit and review their current interventions
against the individual recommendations. The aim is to encourage a reflection on current

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Implementation of the guideline

practice and to consider, where this does not follow the recommendations, the clinical
reasoning in place to support decisions.

A baseline assessment conducted using the audit tool can be repeated to enable review
of progress on actions identified from the audit. It can be useful to undertake a routine
audit every one or two years to monitor ongoing compliance.

The audit form, while initially providing a tool for use within an individual/service
context, offers the potential for future benchmarking.

7.3.3 Continuing professional development session


A set of PowerPoint slides, with notes and interactive activities, provides the resources
for an individual or service to conduct a continuing professional development session
focused on the practice guideline.

The learning outcomes for the session are:

• Explore aspects of the evidence-based guideline/recommendations in relation to


current practice.
• Develop an understanding of the importance of using an evidence-based guideline to
inform practice.
• Explore and develop an understanding of how to use the Royal College of
Occupational Therapists’ audit tool for the evidence-based recommendations.

The slide set can also be valuable in increasing awareness about the guideline, and can
be tailored to meet local needs.

In addition to the audit form, which is most likely to be used by services, a reflective
practice template is available for occupational therapists to review their own practice.

A feedback form is available to provide comment on the guideline and implementation


resources to the Royal College of Occupational Therapists.

Accessing the implementation resources


The quick reference and implementation guide, audit form and continuing professional
development session resources are available as separate documents.

These can be downloaded, together with the full guideline document, from the RCOT
practice resources section (Practice guidelines) of the Royal College of Occupational
Therapists’ website: https://www.rcot.co.uk/practice-resources/rcot-practice-guidelines.

The resources can also be accessed via the web pages of the Royal College of
Occupational Therapists Specialist Section – Trauma and Musculoskeletal Health by
members of the Specialist Section (https://www.rcot.co.uk/about-us/specialist-sections/
trauma-and-musculoskeletal-rcot-ss/member-resources).

­50 Hand and wrist orthoses for adults with rheumatological conditions
8 Recommendations for future
research

The Royal College of Occupational Therapists commenced a research Priority Setting


Partnership with the James Lind Alliance in 2019. This brings together people who access
occupational therapy services, carers, occupational therapists and others working in the
health and care environment in a Priority Setting Partnership to identify and prioritise
‘uncertainties’ or ‘unanswered questions’ about occupational therapy in the UK that they
agree are most important. Once the high-level top 10 research priorities for
occupational therapy research in the UK are available, an important piece of follow-on
work will be supporting the translation of the priorities into more targeted and focused
research priorities within the context of specific clinical areas aligned to RCOT specialist
sections.

In this review of the practice guideline, some of the recommendations lacked any new
supporting evidence which had not already been considered within the original
guideline. For example, there were no new studies on rheumatoid arthritis and wrist
braces or night resting splints. As discussed in previous sections, there may be many
factors influencing this lack of recent research focus, such as a change in interventions
that occupational therapists are using in practice with the impact of biological therapies
in rheumatoid arthritis. Therefore, an important area of future research for occupational
therapists working in rheumatology should be exploring the changing nature of their
role due to recent medical advances.

Another large gap in the evidence is around the economic evaluation of orthotics as an
intervention in rheumatology occupational therapy. Given that occupational therapists
are delivering healthcare in an environment of finite resources, it was agreed by the
guideline review group that the production of statistics and health economics data
would be invaluable in helping occupational therapists maintain current working
practice.

Other areas for future research that were agreed by the guideline review group from the
recent evidence are identified below.

Occupational therapy interventions in rheumatology:

• Identification of the current role of rheumatology occupational therapy in


inflammatory arthritis, including the setting in which they are working, with a shift
towards primary care.
• Emphasis on the importance of early preventative interventions in inflammatory
arthritis, specifically the importance of work-related interventions, and self/lifestyle
management techniques and their effectiveness.
• More multimodal studies that are reflective of clinical practice and that seek to
establish the effectiveness of a range of interventions and their outcomes.
• Exploration of occupational therapy interventions for people with hypermobility, and
the effectiveness of these interventions.

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­51
Recommendations for future research

• Establishing best orthosis design and wearing regimens, taking into account
satisfaction of the wearer (e.g. joint positioning and parameters, movement versus
stability, technical properties of materials, fabrication intensity, day/night/as required,
duration of intervention, concordance, risks, adverse outcomes).
• Long-term effects of orthoses versus alternative treatments (e.g. steroid injection,
surgical intervention, placebo orthoses).

Outcomes and economic evaluation:

• Identification of the volume and cost of prescribing an orthosis for people accessing
services, along with the related health benefits, psychological impact and desired
outcomes, particularly in osteoarthritis of the thumb.
• Investigation into the application of outcome measurement in clinical practice for the
measurement of effectiveness of orthoses, and other occupational therapy
interventions.

­52 Hand and wrist orthoses for adults with rheumatological conditions
9 Guideline development process –
1st edition

Sections 9 and 10 provide details of the development process and methodology for the
first edition of the guideline. Section 11 outlines the review process and update for this
second edition. Detailed information on the following steps in the guideline development
process was written in the Practice guidelines development manual (COT 2011).

9.1 Guideline development group


The membership of the core guideline development group comprised six occupational
therapists with expertise in the field of rheumatology and/or experience of developing
guidelines. A seventh member was co-opted for the second half of the project (see
Appendix 1).

The core group members were all practising therapists, educators or researchers who
undertook guideline development work in their own time, with some support from
employers (for example, to attend meetings). To facilitate timely progression of the
guideline development, much of the liaison and activity was carried out using email
correspondence.

Two members of the Research and Development Team at the Royal College of
Occupational Therapists were co-opted as additional critical appraisers, together with
four individuals who were involved in rheumatology practice or research.

The Research and Development Manager at the Royal College of Occupational


Therapists was co-opted as Editorial Lead.

Given the very specific occupational therapy nature of this practice guideline, it was
determined that the core group would be profession-specific, with wider expertise from
other stakeholders and people who access services obtained outside core group
meetings, via consultation with a virtual reference group.

All comments received from stakeholders, people who access services and occupational
therapists on the draft scope and draft guideline document were reviewed by the
guideline development group. Where appropriate, revisions were incorporated into the
scope form or guideline document prior to submission to the College’s Publications
Group for approval. Conflicts of interest declarations were noted and reviewed for any
necessary action.

In the interests of openness and transparency, details of the comments submitted as


part of the consultation activities are available on request from the Royal College of
Occupational Therapists.

9.2 Stakeholder involvement


Stakeholders expected to have an interest in the guideline topic were identified by the
core group membership at the preliminary guideline meeting. Specific attention was
paid to identifying professional colleagues who may be working as part of a

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Guideline development process – 1st edition

multidisciplinary team, and national charitable or voluntary organisations that may


represent people with rheumatological conditions.

9.2.1 Scope consultation with stakeholders


A core group of stakeholders was approached to comment on an initial draft of the
scope, which was provided in the form of a Stakeholder Information Document
(together with a comments proforma and conflicts of interest declaration form).

The following stakeholders were invited to comment on the scope document:

• British Health Professionals in Rheumatology/British Society for Rheumatology


(BHPR/BSR).
• National Rheumatoid Arthritis Society.
• Chartered Society of Physiotherapy.
• Royal College of Nursing.
• British Association of Hand Therapists.

Comments received were reviewed by the guideline development group and, where
these could be endorsed, the scope was amended accordingly.

9.2.2 Draft guideline consultation with stakeholders


The draft guideline was sent to each of the stakeholders who had been contacted as
part of the scope consultation, for their review and comment.

Feedback from additional stakeholders was also invited:

• Arthritis Research UK.


• European League Against Rheumatism.
• British Association of Prosthetists and Orthotists.

A number of individuals who were in contact with guideline development group


members via professional or local networks, and who expressed an interest in the
consultation, were also invited to participate.

The guideline document and consultation form were placed in the public domain, for a
one-month consultation period, on the COTSS – Rheumatology* website page (from
19/01/15 to 13/02/15).

All comments were discussed at a meeting of the guideline development group and
taken into account during the revision of the final guideline.

9.3 Involvement of people who access services


9.3.1 Scope consultation with people who access services
Three organisations/groups with links to people who access services and fora were
invited to comment on the scope:

* The development and publication of the 1st edition of the practice guideline was funded by the College of Occupational
Therapists and the COT Specialist Section – Rheumatology (now part of the RCOT Specialist Section – Trauma and
Musculoskeletal Health).

­54 Hand and wrist orthoses for adults with rheumatological conditions
Guideline development process – 1st edition

• Arthritis Care Northern Ireland.


• Arthritis Care Scotland.
• Patient Representatives Group (North Bristol NHS Trust).

These groups were selected for their ability to provide a perspective from organisations
representing people who access services, and/or views of individual experts who have
accessed services. A copy of the scope Stakeholder Information Document was sent to
the group contacts.

Comments received were reviewed by the guideline development group and, where
these could be endorsed, the scope was amended accordingly.

9.3.2 Draft guideline consultation with people who access services


Consultation activities with people who access services were undertaken to obtain views
on the guideline recommendations and document.

Arthritis Care Scotland and Arthritis Care Northern Ireland were again invited for their
views and comments.

Additional consultation took place with:

• Individual(s) engaged in patient involvement opportunities via email networks.


• Managed Clinical Network Patient Engagement Group (Greater Glasgow and Clyde
Health Board).

To facilitate different levels of involvement and engagement activities, extracts from the
draft guideline were made available in addition to the full draft. An abbreviated
document was produced to include the recommendation statements summary,
evidence summaries, and the section on optimising outcomes for people who access
services and the potential impact of the recommendations. The document was made
available to individuals identified within networks, fora or organisations for people who
access services/have rheumatological conditions, together with a consultation form
which, while providing the opportunity for open comments, asked five specific
consultation questions (see Section 6).

The guideline development group recognised that the groups engaging in the
consultation process would not necessarily be representative of all individuals living
with a rheumatological condition, in terms of experiences and cultural and ethnic
diversity.

All comments were duly considered for inclusion within the final guideline.

Qualitative feedback from these representatives is quoted alongside the


recommendations where applicable. This approach aims to highlight the individual’s
perspective as an adjunct to the published evidence.

9.4 Occupational therapists’ consultation


The primary audience of the guideline is occupational therapists and, specifically, those
working with people with rheumatological conditions. Ongoing awareness of the
progress of the guideline development project was communicated to the members of

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Guideline development process – 1st edition

COTSS – Rheumatology* via their e-newsletter and website. An article authored by the
guideline development group was also published in the Specialist Section’s journal
(Squire et al 2014).

9.4.1 Scope consultation with occupational therapists


Members of COTSS – Rheumatology* were invited to participate in the scope
consultation by the Specialist Section Chair via the membership email network. A copy of
the scope documentation was provided, with a request for feedback and comment.

Other Specialist Sections of the Royal College of Occupational Therapists were invited to
comment, namely Specialist Sections Trauma and Orthopaedics (as it was known at the
time); Older People; Work; and Independent Practice.

Comments received were reviewed by the guideline development group and, where
these could be endorsed, the scope was amended accordingly.

9.4.2 Draft guideline consultation with occupational therapists


A one-month consultation period enabled members of COTSS – Rheumatology* to
comment on a draft of the full guideline. The Specialist Section’s National Conference
took place during the consultation period and delegates were therefore alerted to the
opportunity to comment on the draft guideline as part of a presentation providing an
update on the progress of the guideline development project.

The consultation was additionally open to any member of the British Association of
Occupational Therapists and was promoted via the monthly professional magazine,
Occupational Therapy News. The draft guideline, along with a consultation feedback and
conflicts of interest form, were made available to members (and the public) via the
College’s website.

All comments were duly considered for inclusion within the final guideline.

9.5 External peer review


Four independent peer reviewers were invited by the guideline development group to
critically appraise a draft of the full guideline. Reviewers were selected for their known
clinical and research expertise in the field, and/or their guideline development
experience or knowledge. The external peer reviewer form asked for comment on both
the presentation and content of the draft guideline, taking into account factors such as
its purpose, robustness and unbiased nature. The detailed views and expert opinions
received were discussed by the guideline development group and used to inform the
content of the final guideline.

9.6 Conflicts of interest


All guideline development group members (core group and co-opted), stakeholders,
occupational therapists and external peer reviewers were required to declare any
pecuniary or non-pecuniary conflicts of interest, in line with the guideline development
procedures (RCOT 2020). People who access services were also asked to declare any
conflicts of interest.

* The development and publication of the 1st edition of the practice guideline was funded by the College of Occupational
Therapists and the COT Specialist Section – Rheumatology (now part of the RCOT Specialist Section – Trauma and
Musculoskeletal Health).

­56 Hand and wrist orthoses for adults with rheumatological conditions
Guideline development process – 1st edition

The nature of the potential or actual conflicts made in the declarations (see Appendix 3)
were not determined as being a risk to the transparency or impartiality of the guideline
development.

The editorial lead for the guideline was a member of staff at the Royal College of
Occupational Therapists, who attended guideline meetings as an ‘officer in attendance’.
The recommendation statements and guideline content were, however, developed and
finalised by the guideline development group with the involvement of stakeholders,
representatives of people who access services, and occupational therapists, and were
externally peer reviewed. The views of the Royal College of Occupational Therapists have
not, therefore, unduly influenced the final recommendations in this guideline.

9.7 Declaration of funding for the guideline development


The practice guideline was developed by a group led by a Specialist Section of the Royal
College of Occupational Therapists. Specialist Sections are official branches of the
College with specialist interests which, through their membership, are able to engage
expert practitioners, educators and researchers in the development of guidelines, and
access the required clinical and research expertise.

As a membership organisation, the major source of funding for the Royal College of
Occupational Therapists and its Specialist Sections is from membership. Other sources
of income are primarily from advertising and events.

The development and publication of the first edition of the practice guideline was
funded by the College of Occupational Therapists and COTSS – Rheumatology*. The
Royal College of Occupational Therapists provided specific resources to cover the
meeting venue, travel expenses, literature search, editorial and publication support. A
small ring-fenced allocation was made by the National Executive Committee of the
Specialist Section to fund any other costs associated with the development and
promotion of the practice guideline.

Manufacturers and distributors of orthoses and materials for fabrication were viewed by
the guideline development group as being stakeholders, but a decision was made not to
include them in the project to avoid any potential for commercial bias or influence.
There were no external sources of funding. The project lead, who chaired meetings, was
a member of COTSS – Rheumatology*, but was not a National Executive Committee
member so had no direct decision-making relationship with the allocated funding for the
project.

9.8 Royal College of Occupational Therapists’ appraisal and


ratification process
The guideline proposal, scope and final document were all reviewed and subsequently
ratified by the Practice Publications Group, in line with the requirements of the Practice
guidelines development manual (COT 2011).

The scope was approved by the Practice Publications Group in March 2014 and the final
version of the first edition of the guideline was approved by the Practice Publications
Group in May 2015.

* The development and publication of the 1st edition of the practice guideline was funded by the College of Occupational
Therapists and the COT Specialist Section – Rheumatology (now part of the RCOT Specialist Section – Trauma and
Musculoskeletal Health).

Royal College of Occupational Therapists 2020


­57
10 Guideline methodology

10.1 Guideline questions

• Is there evidence to support the use of hand and wrist orthoses as an intervention
for adults living with a rheumatological condition?
• Is there any evidence of harm arising from the use of an orthosis that practitioners
should be aware of?

The PICO framework (Huang et al 2006, Richardson et al 1995) was used to assist in
developing the specific practice question further (see Table 10.1). PICO describes the
specific care group or condition being studied, and the nature of the intervention to be
investigated.

A comparative treatment can be specified where applicable, together with the


anticipated outcomes (the desired/undesired or expected results of the intervention).
This level of specificity is important in developing the question so that it addresses the
requirements of the scope (RCOT 2020).

Table 10.1: PICO framework

Patient (person who accessed Adults, 16 years and over, who have a
services), Population or Problem/ rheumatological condition involving the hand or
circumstance wrist

Intervention under investigation Orthoses


or action
Comparison, which is an None
alternative intervention or action
Outcome desired Optimising occupational performance by
improving:
• Pain.
• Swelling.
• Deformity (including hand appearance).
• Self-efficacy.
• Dexterity.
• Sensory symptoms.
• Grip strength.
• Range of movement (ROM).
• Quality of life.
• Self-management strategies.

­58 Hand and wrist orthoses for adults with rheumatological conditions
Guideline methodology

10.2 Literature search strategy and outcomes


The literature search was carried out by Royal College of Occupational Therapists
librarians, experts in the field of occupational therapy literature, using a search strategy
defined following discussion and agreement with the guideline development group.

10.2.1 Key terms


The strategy involved combining concept groups of key words. Six key categories or
concepts and their related terms were identified: condition/problem; alternative
conditions; limb-related terms; intervention; occupational therapy terms; and cost-
related terms (see Appendix 4, Table A1).

Specific exclusions identified were: material published pre-2004, individuals under 16 years
of age, and language other than English (due to lack of resources for translation). All study
designs were considered potentially relevant.

10.2.2 Databases
The databases searched reflected the most likely sources of published peer-reviewed
occupational therapy rheumatology evidence. Seven core databases were searched
from 1 January 2004 to the dates the individual searches were carried out (in 2014), as
detailed in Table 10.2.

Table 10.2: Database searches

Core databases
Cumulative Index to Nursing and Health Literature
Federated search 20/05/14
(CINAHL) MEDLINE
Allied and Complementary Medicine (AMED)
PsycINFO
Federated search 16/05/14
Social Policy and Practice
Health Management Information Consortium (HMIC)
PubMed 15/05/14

Additional specialist databases were also searched: OTDBASE; OT SEARCH; OTseeker;


the Cochrane Library (including the NHS Economic Evaluation Database – NHS EED);
Ethos; ProQuest; and the Royal College of Occupational Therapists’ Library catalogue.
Hand-searching of the Journal of Rheumatology Occupational Therapy and relevant
websites was also undertaken.

Searches included title, abstract or descriptor fields. The date of each search, search
fields and search result numbers are detailed in Appendix 4 (Tables A2 and A3). A
10-year time frame was identified as appropriate for the search period.

Full search histories are available on request from the Royal College of Occupational
Therapists.

10.2.3 Search results


The search identified a total of 2,069 results. These were scrutinised for duplicates, both
within database searches and cross-database search returns, by the Royal College of

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Guideline methodology

Occupational Therapists’ Research and Development Manager. A total of 1,404


duplicates were removed. The unique results list was provided to the project lead and
guideline development group members undertaking the screening activity.

10.3 Criteria for inclusion and exclusion of evidence


The resultant 665 search findings (title and abstracts) were each independently screened
by two different members of the guideline development group against an eligibility
checklist:

Inclusion criteria:

• Adults aged over 16 years.


• Orthoses.
• Rheumatological condition.
• Hand/wrist.

Exclusion criteria:

• Crystal arthropathy.
• Fibromyalgia.
• Hypermobility.
• Neurological conditions.
• Elbow, knee, foot or neck orthoses.
• Post-operative orthoses.
• Hand assessment.
• Fabrication of orthoses.

The allocation process ensured that guideline development group members did not
screen any evidence that they had authored or co-authored. Where two screeners had a
yes/no variation in opinion as to whether an abstract should be included or excluded for
appraisal, the abstract was further reviewed against the eligibility criteria to make a
consensus decision. If consensus could not be reached, this was referred to a guideline
development group meeting for a consensus decision.

This process enabled the identification of abstracts that would be potentially relevant to
the practice guideline and that should therefore be included within the critical appraisal
process.

Following the screening, 490 items were further excluded, resulting in a total of 175
items identified for full paper review and critical appraisal.

A total of 175 articles were critically appraised and details transferred into evidence
tables (see Section 10.4); 31 items of evidence were subsequently used in developing the
recommendations (see Section 10.5).

An overview of the literature search outcomes is provided in Figure 10.1.

­60 Hand and wrist orthoses for adults with rheumatological conditions
Guideline methodology

Total search
results
n=2,069

Preliminary Exclude
cleansing n=1,404

Abstracts
included
n=665

Screened Exclude
against criteria n=490

Full articles
included
n=175

Critical appraisal Exclude


n=235 n=144

Evidence
included
n=31

Figure 10.1: Literature search outcomes

10.4 Strengths and limitations of body of evidence


Each of the 175 articles identified as potential evidence was critically appraised by two
independent reviewers. Appraisals were undertaken by all members of the guideline
development group, with additional support provided by co-opted members. The
allocation process ensured that reviewers did not appraise any evidence that they had
authored or co-authored. Any discrepancy in grading was discussed, and the final
grading agreed and confirmed by the two original reviewers or via group consensus.

The quality of the evidence was initially assessed and recorded using forms based on
the Critical Appraisal Skills Programme (CASP) checklists (CASP 2013). Assessment took
into account factors such as the appropriateness of the study design and recruitment
strategy; procedural rigour in data collection and analysis; confounding factors and
potential biases; transferability; precision of results; and the value of the findings.

A quality of evidence grade was then assigned to each individual article using the
Grading of Recommendations Assessment, Development and Evaluation (GRADE)

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Guideline methodology

approach, as defined within the Practice guidelines development manual (COT 2011). The
grading reflects the research design and the confidence in the research findings.

The initial grading was allocated as follows:

• Randomised controlled trial (RCT)/systematic review = High.


• Observational study = Low.
• Any other evidence = Very Low.

Limitations in the design of a study or its implementation may, however, bias the
estimates of the treatment effect. If there were serious limitations, then downgrading of
the quality of the evidence was considered, as in Table 10.3.

Table 10.3: Grading evidence up or down (after GRADE Working Group 2004)

Decrease grade if • Serious or very serious limitation to study quality.


• Important inconsistencies in results.
• Some or major uncertainty about directness of the evidence.
• Imprecise or sparse data (relatively few participants and/or
events).
• High probability of reporting bias.
Each quality criterion can reduce the quality by one or, if very
serious, by two levels.
Increase grade if • Magnitude of the treatment effect is very large and
consistent.
• Evidence of a large dose–response relation.
• All plausible confounders/biases would have decreased the
magnitude of an apparent treatment effect.
Only studies with no major threats to validity should be upgraded.

The decision to increase or decrease the initial grade of the evidence was recorded and
justified on the critical appraisal forms. A moderate category became relevant only if
there was a suggested change in the initial grading of an article due to up- or
downgrading. Evidence was ultimately graded in one of four categories, as detailed in
Table 10.4.

If there was no reason to up- or downgrade the evidence, then the original grading
remained.

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Guideline methodology

Table 10.4: GRADE quality of evidence grading (after GRADE Working Group 2004)

Quality of Grading Characteristics Confidence


evidence
High A Based on consistent results True effect lies close to that
from well-performed of the estimate of the effect.
randomised controlled trials, Further research is very
or overwhelming evidence of unlikely to change
an alternative source, e.g. confidence in the estimate
well-executed observational of the effect.
studies with strong effects.
Moderate B Based on randomised True effect likely to be close
controlled trials where there to the estimate of the effect
are serious flaws in conduct, but there is a possibility that
inconsistency, indirectness, there could be a substantial
imprecise estimates, difference. Further research
reporting bias or some other is likely to have an important
combination of these impact on confidence in the
limitations, or from other estimate of effect and may
study designs with special change the estimate.
strengths.
Low C Based on observational True effect may be
evidence, or from controlled substantially different from
trials with several very the estimate of the effect.
serious limitations. Further research is very
likely to have an important
impact on confidence in the
estimate of the effect and is
likely to change the
estimate.
Very Low D Based on case studies or Any estimate of effect is very
expert opinion. uncertain and may be far
from the true effect.

Once the methodological quality of each piece of evidence had been assessed, details
for each item of evidence were collated, from the two independent appraisals, into an
evidence table (Appendix 6).

10.5 Method used to arrive at recommendations


The evidence tables were used by the guideline development group to synthesise the
evidence available, and as the basis to evaluate and judge the potential contribution of
each item of evidence to the development of the guideline recommendations.

The identified outcomes (Table 10.1) were used as the starting point, in conjunction with
condition and orthosis types identified from the appraised evidence. Where evidence
was identified to support an outcome or theme, this was reviewed. Each individual
group member contributed their expert views to the discussion to develop
recommendation options.

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Guideline methodology

Where a number of items of evidence supported an identified outcome and subsequent


recommendation, an overall quality of evidence rating was determined. This overall
rating was established as follows:

• Where the evidence outcomes pointed in different directions towards benefit and
towards harm, the lowest quality of evidence determined the overall quality grade of
evidence.
• Where the outcomes pointed in the same direction towards either benefit or harm,
the highest quality of evidence was appropriate to recommend an intervention and
determined the overall quality of evidence.
• In circumstances where the balance of benefits and harm was uncertain, the lowest
grade of quality of evidence was assigned.

Strength of recommendation was the second element of the GRADE system applied
using the categories, strong or conditional, to reflect the strength (Table 10.5).

Table 10.5: Strength of grade (after Guyatt et al 2008)

Strength Grade Benefits and risks Implications


Strong 1 Benefits appear to Most people would
‘It is recommended. . .’ outweigh the risks want or should receive
(or vice versa) for this course of
the majority of the intervention or action.
target group.
Conditional 2 Risks and benefits The majority of people
‘It is suggested. . .’ are more closely would want this
balanced, or there intervention, but not
is more uncertainty all, and therefore they
in likely values and should be supported
preferences of the to arrive at a decision
person. for intervention
consistent with the
benefits and their
values and
preferences.

The development of the recommendations, including assignment of the overall quality


and strength grading, was a consensus decision obtained at the guideline development
group meeting, and by subsequent email correspondence as required for any revisions.
There were no recommendations which were not agreed by all members, so that no
formal voting system or use of the nominal group technique was required. Thirty-one
items of evidence were used to develop the recommendations.

A recommendation decision form was completed for each recommendation developed.


This recorded key information about the evidence used to form the basis of that
recommendation, the overall allocation of the quality of evidence and strength of the
recommendation. The form also facilitated discussion and recording of any specific or
associated risks and benefits, and this was reflected in the final strength of
recommendation. Any judgement by the guideline development group was documented
as part of this decision-making process (the forms are available on request from the
Royal College of Occupational Therapists).

­64 Hand and wrist orthoses for adults with rheumatological conditions
11 Guideline review process –
2nd edition

The guideline review commenced in 2018, three years after publication of the guideline,
and followed the review process as outlined in the Practice guideline development manual
(RCOT 2020, Section 3.14).

The guideline question, objective and scope were unchanged, as were the criteria for
inclusion or exclusion of evidence. This section outlines the process followed and, where
necessary, cross-references to the first edition development process and methodology.

11.1 Guideline review group established


The guideline review group consisted of one member of the original guideline
development group and seven new members. All were occupational therapists with
expertise and specialist interest in rheumatological conditions and orthoses. Conflicts of
interest were declared in line with the guideline development process requirements.

11.2 Identification of new evidence


Monitoring searches were carried out in 2016 and 2017 to ensure no significant studies
had been published which would require an immediate change to the recommendations
or withdrawal of the guideline. All searches were undertaken by the Royal College’s
Library and Information Service.

11.2.1 Key search terms


The monitoring search (2015–2016) and full review search strategies replicated the first
edition guideline search terms across the databases and platforms. These searches
involved combining groups of search terms from six categories or concepts and their
related terms: two sets of conditions, limb-related terms, interventions, occupational
therapy and related terms, and finance/value terms (Appendix 5, Tables A5, A7 and A8).

The monthly monitoring searches (from 2016) used a reduced set of terms and
combinations (Appendix 5, Table A6).

11.2.2 Databases
The monthly monitoring searches were carried out on the EBSCOHOST and OVID
platforms only. For the full review search, core and specialist databases were searched
from the last date of the first edition guideline search (May 2014 to October 2018). The
databases accessed were: EBSCOHOST platform (MEDLINE, CINAHL); OVID platform
(AMED, HMIC, PsycINFO, Social Policy and Practice); OTseeker; OTDBASE; OT SEARCH;
Cochrane Library; NHS EED, PubMed, PubMed Central, ETHOS (now part of the British
Library); and RCOT Library online catalogue. Relevant websites were also searched.

Details for the specific database searches are provided in Appendix 5, Tables A5–A8.

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Guideline review process – 2nd edition

11.2.3 Search results


The monitoring searches undertaken from 2015 returned 135 results (EBSCOHOST
platform n=126 and OVID platform n=9). The College Officer cleansed for duplicates and
anomalies within and across databases, resulting in 11 articles for screening. No articles
were identified as presenting evidence that any recommendations should be changed to
prevent harm.

For the full search undertaken in October 2018, the core and specialist searches
produced a total of 1,116 results (EBSCOHOST platform n=230, OVID platform n=48 and
specialist databases/websites n=838). Following cleansing by the College Officer, 291
abstracts were suitable for screening.

11.2.4 Screening and appraisal of evidence


A total of 291 abstracts were independently screened by two members of the guideline
review group against criteria identified in the guideline development process (Section
10.3). This resulted in 230 items being excluded, and 61 items of evidence being selected
for independent appraisal by two group members.

An overview of the full literature search is provided in Figure 11.1.

Search
results
n=1,116
Exclude
n=825
Preliminary
cleansing

Abstracts
for screening
n=291

Screened Exclude
against criteria n=230

Unique articles
for appraisal
n=61

Exclude
Critical appraisal
n=48

Evidence
included
n=13

Figure 11.1: Review full literature search

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Guideline review process – 2nd edition

11.3 Assessment of update requirements


A total of 13 articles were agreed unanimously by the group as providing new evidence
for inclusion in an update of the guideline, supporting four existing recommendation
statements. Additionally, one article identified in the first edition guideline was used to
add support to an existing recommendation. To note, systematic reviews that only
discussed articles used as evidence in the first edition of the guideline were discounted.

The 13 new items of evidence were mostly graded as Moderate (Grade B, n=7), with
three each graded Low (Grade C, n=3) or Very low (Grade D, n=3).

The guideline review group’s discussions focused on the update required for the second
edition in terms of:

• New evidence appraised.


• Development of recommendations where indicated by new evidence or knowledge.
• Consideration of any original material that was no longer appropriate and how this
might need to be replaced or withdrawn.
• Consideration of any relevant feedback and comments received since the publication
of the guideline.

11.4 External review


A consultation of the revised draft guideline was held with stakeholders, members of the
public and occupational therapists from October to November 2019. Where permission
was given, those who participated are listed in the acknowledgements (Appendix 2).

Occupational therapists: the draft updated guideline was made available to


occupational therapists, particularly members of the Royal College’s Specialist
Section – Trauma and Musculoskeletal Health. All members were alerted to the
consultation via the professional body’s magazine OTnews, the website and social
media.
Stakeholders: stakeholders who had been invited to participate in the original
consultation were contacted and invited to provide any comments on the full
updated version of the guideline along with new stakeholders identified by
guideline review group members.
Members of the public: Versus Arthritis advertised details about the consultation on
its social media channels.
Peer review: two peer reviewers, experienced in both the topic and research, were
identified to carry out an independent peer review of the updated draft.

11.5 College appraisal and ratification process


A draft of the second edition of the guideline was submitted to the College’s Publications
Group for review and was approved in April 2020.

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Guideline review process – 2nd edition

11.6 Overview of limitations and any potential bias of the


guideline
Evidence included in the development and review of the guideline recommendations was
sourced from published, peer-reviewed journal articles. Relevant policy documents have
been referenced within the contextual information where applicable, but it is
acknowledged that grey literature has not been included in the evidence.

The literature search identified a body of primary research, relating predominantly to


the provision of an orthosis for thumb base osteoarthritis, functional wrist orthoses for
rheumatoid arthritis, and some studies that researched the use of silver ring splints or
Oval-8® orthoses for swan neck deformity as a consequence of rheumatoid arthritis. The
review of the literature for the first and second editions of the guideline combined
identified 44 items of evidence from which recommendations were developed.

A total of 52.3% of the evidence was derived from high- or moderate-quality studies (see
Table 10.6 for more details):

Grade A = 18.2% (n=8)


Grade B = 34.1% (n=15)
Grade C = 31.8% (n=14)
Grade D = 15.9% (n=7)

A number of studies in the first edition guideline literature search were appraised which
considered orthoses as an intervention for carpal tunnel syndrome. These resulted in
discussion by the guideline development group, as many were considered to fall outside
the scope of the guideline, in that the populations involved excluded those with
inflammatory or rheumatoid conditions. A consensus was reached regarding their
exclusion. In the review for the second edition, the literature search also found articles
related to carpal tunnel syndrome, but as per the development of the guideline, all were
excluded due to the exclusion of the guideline’s target population.

As in the first guideline literature search, limited evidence was identified with respect to
orthoses for trigger finger, Boutonnière deformity, ulnar deviation, or for osteoarthritis
of the distal interphalangeal joints. This evidence was insufficient to develop a specific
recommendation, either to support or to refute the prescription of an orthosis.
Additional information is provided in Appendix 7.

There was limited literature on the use of compression gloves in rheumatological


conditions. Contemporary research indicates that compression gloves of mid-finger
length are no more effective than loose-fitting gloves in people with rheumatoid arthritis
or inflammatory arthritis (Hammond et al 2018a), which could have a considerable
impact on occupational therapy practice. However, the study’s findings were published
as abstracts in peer-reviewed journals, which does not meet the criteria for high-level
evidence to support guideline recommendations. Update 2022: see also the addendum
to this guideline.

The evidence did provide several higher-quality studies from a design and
methodological perspective. The guideline development and review groups downgraded
15 of the potential grade A studies due to limitations identified from the appraisal and a
resultant lack of confidence in the estimate of the research effect. Systematic reviews
were mainly graded as A or B, which was based on the robustness of the review

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Guideline review process – 2nd edition

methodology and reported outcomes. This did not necessarily reflect, however, the
quality of the individual studies included within the review.

The evidence identified did have some overarching limitations. While there have been a
number of research studies undertaken, the majority of these were small-scale,
underpowered and of limited follow-up duration. Study populations were mostly
heterogeneous and the nature of the orthosis design and the wearing regimens used in
international research can differ from UK practices. Only a small proportion of the primary
research was conducted in the UK, and therefore there may be medical management
differences and orthotic prescription factors that could influence generalisation.

Additionally:

• Not all studies provided adequate information on the orthosis being investigated,
which would make reproduction of the intervention a challenge. Many commercially
available prefabricated wrist and hand orthoses are described in papers by their trade
name, which can be country specific. A full description of the orthosis, with the
inclusion of a photograph, would be needed to enable the replication of the
intervention/study.
• A number of papers failed to explicitly state the wrist angle of the orthosis, and/or
there appeared to be no attempt to determine if the wrist was held in a
predetermined position during task performance, or to see if the orthosis maintained
the angle of wrist extension after a period of use.
• There appeared to be little or no attempt to quantify ‘fit’, which underpins optimal
orthotic treatment. This will have an impact not only on function but also, importantly,
on comfort, both of which influence compliance. Information on fitting complications
and rejection rates was rarely provided.

Details on specific limitations of individual studies are noted in the evidence tables in
Appendix 6.

Table 11.1: Summary of evidence used to develop the recommendations

Category Author Year Evidence quality


Rheumatoid Ramsey et al 2014 A
arthritis: Giesen et al 2010 D
orthoses for
Giesen et al 2009 C
activity and
rest Spicka et al 2009 D
Thiele et al 2009 C
Adams et al 2008 B
Silva et al 2008 A
Veehof et al 2008a B
Pagnotta et al 2005 C
Haskett et al 2004 B
Zijlstra et al 2004 C
Osteoarthritis: Cantero-Téllez et al 2018 B
base of thumb Vegt et al 2017 B
orthoses
Bani et al 2014 C

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Guideline review process – 2nd edition

Osteoarthritis: Hamann et al 2014 D


base of thumb Hermann et al 2014 B
orthoses
Maddali-Bongi et al 2014 C
Bani et al 2013a C
Bani et al 2013b A
Becker et al 2013 B
Kjeken et al 2011a A
Kjeken et al 2011b A
Sillem et al 2011 B
Gomes Carreira et al 2010 B
Boustedt et al 2009 C
Moe et al 2009 A
Rannou et al 2009 A
Egan and Brousseau 2007 B
Wajon and Ada 2005 A
Weiss et al 2004 C
Optimising Cantero-Téllez et al 2018 B
individual Duong et al 2018 D
outcomes
Healy et al 2018 B
Tada et al 2018 D
Almeida et al 2017 B
Shankland et al 2017 C
Vegt et al 2017 B
Aebischer et al 2016 B
Hammond et al 2016 C
Bertozzi et al 2015 B
Spaans et al 2015 B
Bani et al 2014 C
Nasir et al 2014 C
Bani et al 2013a C
Bani et al 2013b A
Becker et al 2013 B
Gooberman-Hill et al 2013 D
Kjeken et al 2011a A
Sillem et al 2011 B
Gomes Carreira et al 2010 B
Boustedt et al 2009 C
Giesen et al 2009 C
Rannou et al 2009 A
Thiele et al 2009 C
Boer et al 2008 C
Silva et al 2008 A

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Guideline review process – 2nd edition

Optimising Veehof et al 2008a B


individual Veehof et al 2008b C
outcomes
Pagnotta et al 2005 C
Wajon and Ada 2005 A
Haskett et al 2004 B
McKee and Rivard 2004 D
Weiss et al 2004 C
Zijlstra et al 2004 C

The involvement of the Royal College and the Specialist Section in the development,
authoring and funding of this practice guideline is fully acknowledged (Section 9.6).
Involvement is inherent because of the organisational structure of the professional body
and its relationship with its members.

The potential for any bias in development and authoring was, however, minimised
through the rigorous nature of the guideline development process. This was achieved
through the systematic methodology adopted, the contributions of stakeholders and
people who access services, the valued opinions of the independent peer reviewers and
occupational therapists, and the judicious management of any potential or actual
conflicts of interest.

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12 Updating the guideline

The National Executive Committee of the Royal College of Occupational Therapists


Specialist Section – Trauma and Musculoskeletal Health is responsible for monitoring
new evidence over the next five years and will provide a focal point for feedback
received following publication of the second edition of the guideline. If you would like to
provide feedback on the guideline or implementation tools, please go to https://www.
rcot.co.uk/about-us/specialist-sections/trauma-and-musculoskeletal-rcot-ss/contacts-and-
committee for up-to-date contacts for the specialist section.

In line with College procedures, this reviewed guideline will be available until 2025 and
then withdrawn; however, relevant literature will be monitored regularly to detect new
evidence that may have a significant impact on the recommendations. If this occurs, the
guideline may be withdrawn earlier, depending on the strength of the evidence.

­72 Hand and wrist orthoses for adults with rheumatological conditions
Appendix 1: Guideline development
and review groups

Guideline Development Group, 2013–2015


Ruth Squire (Project Lead)
• MSc, DipCOT
• Lecturer in Occupational Therapy, Cardiff University, Wales
• Member of: College of Occupational Therapists* Specialist Section – Rheumatology**;
British Health Professionals in Rheumatology – Education Officer

Katie McAlarey
• DipCOT
• Clinical Specialist Occupational Therapist in Rheumatology, New Victoria Hospital,
Glasgow, Scotland
• Member of: College of Occupational Therapists Specialist Section – Rheumatology;
British Health Professionals in Rheumatology; Scottish Society for Rheumatology

Professor Jo Adams
• PhD, MSc, DipCOT
• Professor of Musculoskeletal Health; Professional Lead for Occupational Therapy,
Southampton University
• Member of: College of Occupational Therapists Specialist Section – Rheumatology;
British Health Professionals in Rheumatology

Dr Lucy Blenkiron
• PhD, MSc, DipCOT
• Clinical Specialist in Rheumatology and Lead Occupational Therapist, North Bristol
NHS Trust
• Member of: College of Occupational Therapists Specialist Section – Rheumatology;
British Health Professionals in Rheumatology

Sarah Bradley
• MSc Hand Therapy, DipCOT
• Advanced Practitioner in Hand Therapy, Poole Hospital, Dorset
• Member of: College of Occupational Therapists Specialist Section – Rheumatology;
British Health Professionals in Rheumatology; British Association of Hand Therapists

* The Royal College of Occupational Therapists was granted permission to use the term ‘Royal’ in 2017. Prior to that, it
was known as the College of Occupational Therapists.
** The development and publication of the 1st edition of the practice guideline was funded by the College of Occupational
Therapists and the COT Specialist Section – Rheumatology (now part of the RCOT Specialist Section – Trauma and
Musculoskeletal Health).

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Appendix 1: Guideline development and review groups

Lucia Ramsey
• BSc(Hons) Occupational Therapy, PgCHEP, AHT
• Lecturer in Occupational Therapy, Ulster University, Jordanstown, Northern Ireland
• Member of: College of Occupational Therapists Specialist Section – Rheumatology;
British Health Professionals in Rheumatology; Irish Rheumatology Health
Professionals Society; British Association of Hand Therapists; Fellow of the Higher
Education Academy

Co-opted member to group (from September 2014)

Cathy Ball
• MSc Health Sciences (University of East Anglia), DipCOT
• Research Clinical Specialist in Hand Therapy, Kennedy Institute of Rheumatology,
University of Oxford
• Member of: College of Occupational Therapists Specialist Section – Rheumatology;
British Health Professionals in Rheumatology; British Association of Hand Therapists

Guideline Review Group, 2018–2020


Ruth Squire (Project Lead)
• Senior Lecturer in Occupational Therapy, Cardiff University, Wales
• Member of: Royal College of Occupational Therapists Specialist Section – Trauma and
Musculoskeletal Health; British Society for Rheumatology

Patricia Bisset
• Occupational therapist practitioner, Greater Glasgow and Clyde NHS
• Member of: Royal College of Occupational Therapists Specialist Section – Trauma and
Musculoskeletal Health; Royal College of Occupational Therapists Specialist Section
– Older People; Scottish Society for Rheumatology

Elizabeth Doherty
• Occupational therapist practitioner, East Lancashire Hospitals NHS Trust
• Member of: Royal College of Occupational Therapists Specialist Section – Trauma and
Musculoskeletal Health; North West Rheumatology Occupational Therapist Group

Kerry Edwards
• Senior Lecturer, York St John University
• Member of: Royal College of Occupational Therapists

Jo Harness
• Occupational therapy practitioner, North Devon NHS Healthcare Trust

­74 Hand and wrist orthoses for adults with rheumatological conditions
Appendix 1: Guideline development and review groups

• Member of: Royal College of Occupational Therapists Specialist Section – Trauma and
Musculoskeletal Health; British Society for Rheumatology; British Association of Hand
Therapists

Laura Ingham
• Occupational therapy practitioner, Swansea Bay University Health Board; Associate
Lecturer in Occupational Therapy, Cardiff University, Wales
• Member of: Royal College of Occupational Therapists Specialist Section – Independent
Practice; British Association of Hand Therapists

Katharine Noel
• Occupational Therapist, Norfolk and Norwich University Hospital
• Member of: Royal College of Occupational Therapists; British Association of Hand
Therapists; British Health Professionals in Rheumatology

Ebby Sigmund
• Occupational therapist practitioner, NHS Dumfries and Galloway
• Member of: Royal College of Occupational Therapists Specialist Section – Trauma and
Musculoskeletal Health; Royal College of Occupational Therapists Specialist Section
– Older People; Royal College of Occupational Therapists Specialist Section –
Independent Practice; British Association of Hand Therapists; British Society for
Rheumatology; Scottish Society for Rheumatology
• Associate with Somek and Associates and The OT Practice

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Appendix 2: Acknowledgements

The guideline review group would like to thank all those who have contributed to the
development of this edition of the practice guideline and the first edition.

A2.1 Guideline development – 1st edition


A2.1.1 People who access services reference groups and individuals

• Arthritis Care Scotland – Maureen McAllister, Joint Working Project Manager


• Arthritis Care Northern Ireland
• Patient Representative Group (North Bristol NHS Trust)
• Managed Clinical Network Patient Engagement Group (Greater Glasgow and Clyde
Health Board)
• Five individuals (experts who access services) responded to the draft guideline
consultation:
• Miss Wendy Spencer
• Mr William McGinn, Patient and Carer Forum Member
• Three people who preferred to remain anonymous

A2.1.2 Stakeholders

• Jill Firth, Consultant Nurse in Rheumatology, Pennine Musculoskeletal Partnership;


Honorary Secretary of British Health Professionals in Rheumatology
• Margaret Hayden, Occupational Therapist specialising in hand therapy, British
Association of Hand Therapists
• Dr Anne McEntegart, Consultant Rheumatologist, Stobhill Hospital, Glasgow; Chair of
the Managed Clinical Network in Greater Glasgow and Clyde Health Board
• Scott McNab, Orthotist, Peacocks Medical Group, British Association of Prosthetists
and Orthotists (BAPO) Professional Affairs Committee
• Dr Joseph McVeigh, Lecturer in Physiotherapy, Ulster University/Chartered Society of
Physiotherapy
• National Rheumatoid Arthritis Society
• Michaela Stoffer, Head of Degree Programme Occupational Therapy, University of
Applied Sciences for Health Professions Upper Austria; Member of the Health
Professional Scientific Subcommittee of the European League Against Rheumatism
(EULAR); Liaison Officer to EULAR for the Austrian Association for Health Professionals
in Rheumatology

­76 Hand and wrist orthoses for adults with rheumatological conditions
Appendix 2: Acknowledgements

A2.1.3 External peer reviewers

• Dr Jenny Lewis, Senior Clinical Research Occupational Therapist and NIHR Lecturer,
Royal National Hospital for Rheumatic Diseases, NHS Foundation Trust and University
for West of England
• Dr Margaret McArthur, Honorary Fellow, School of Health Sciences, University of East
Anglia, Norwich
• Dr Elaine Morrison, Consultant Physician and Rheumatologist, NHS Greater Glasgow
and Clyde
• Karyn Ross, Teaching Fellow, National Centre for Prosthetics and Orthotics,
Department of Biomedical Engineering, University of Strathclyde, Glasgow

A2.1.4 Co-opted critical appraisers

• Naomi Algeo BSc Occupational Therapy, Research Intern, Arthritis Research UK: Centre
for Sport, Exercise and Osteoarthritis
• Lisa Newington MSc Physiotherapy, BSc (Hons), Health Education Wessex; Allied
Health Professional Research Intern and Clinical Specialist Hand Therapist, London
Hand and Wrist Unit
• Mandy Sainty MSc, DipCOT, Research and Development Manager, Royal College of
Occupational Therapists
• Caroline Spicka MSc Health and Rehabilitation, OT degree, Occupational Therapist,
University Hospitals Trust Southampton
• Dr Elizabeth White PhD, Head of Research and Development, Royal College of
Occupational Therapists

A2.1.5 Occupational therapists and physiotherapists

Eighteen occupational therapists and physiotherapists responded to the draft guideline


consultation. Those who wished to be acknowledged are listed below:
• Kirsty Bancroft, Hand Occupational Therapist, Poole Hospital NHS Foundation Trust
• Bridget Ellis, Clinical Specialist Physiotherapist – Hand Therapy, Poole Hospital NHS
Foundation Trust
• Janet Harkess, Head Occupational Therapist, NHS Fife
• Jo Harness, Advanced OT Practitioner – Rheumatology, Northern Devon Healthcare Trust
• Charlie Laver, Specialist Occupational Therapist, Pennine MSK Partnership Ltd
• Alison Leiper, AHP Coordinator for Rheumatology for Greater Glasgow and Clyde
• Rhoda Mackay, Occupational Therapist, NHS Western Isles
• Christina Macleod, Occupational Therapist, Hampshire Hospital Foundation Trust
• Caroline Mountain, Occupational Therapist, Portsmouth Hospitals NHS Trust
• Lisa Newington, Health Education Wessex, Allied Health Professional Research Intern;
and Clinical Specialist Hand Therapist, London Hand and Wrist Unit
• Ebby Sigmund, Occupational Therapist, Rheumatology Outpatients, NHS Dumfries and
Galloway

Royal College of Occupational Therapists 2020


­77
Appendix 2: Acknowledgements

• Caroline Spicka, Occupational Therapist, University Hospitals Trust, Southampton


• Nicola Walker, Team Manager/Advanced Clinical Specialist Rheumatology, East
Cheshire Trust/Mid Cheshire Hospitals NHS Foundation Trust
• Julie Weeks, Freelance Occupational Therapist and Complementary Practitioner

Scope consultation respondents included COTSS – Rheumatology* members, and a


representative from COTSS – Trauma and Orthopaedics and COTSS – Older People.

The guideline development group would additionally like to thank the following:
• Shona MacNeilage, NHS Library Manager, Greater Glasgow and Clyde Health Board

A2.2 Guideline development – 2nd edition


A2.2.1 Stakeholders

• Scott McNab, Senior Orthotist, Peacocks Medical Group and British Association of
Prosthetists and Orthotists (BAPO) Profession Affairs Chair, on behalf of BAPO
• Dr Yeliz Prior, Advanced Clinical Specialist Occupational Therapist, Leighton Hospital,
Mid Cheshire Hospitals NHS Foundation Trust; Senior Research Fellow, School of
Health and Society, University of Salford; Vice-President Elect British Society for
Rheumatology (BSR) and Chair Elect of British Health Professionals in Rheumatology
(BSR), on behalf of BSR
• Jo Young, Clinical Specialist Occupational Therapy – Hand Therapy and Rheumatology,
Gloucestershire Hospitals NHS Foundation Trust, on behalf of the British Association
of Hand Therapists
• One who preferred to remain anonymous.

A2.2.2 External peer reviewers

• Dr Elaine Morrison, Consultant Physician and Rheumatologist, Queen Elizabeth


University Hospital, Glasgow
• Sandi Derham, Rheumatology Occupational Therapist Clinical Specialist, Royal
National Hospital for Rheumatic Diseases, part of Royal United Hospitals Bath NHS
Foundation Trust

A2.2.3 Occupational therapists

• Dervil Dockrill, Clinical Specialist Occupational Therapist, University of Edinburgh

A2.2.4 The guideline review group would additionally like to thank:

• The Royal College of Occupational Therapists Library Service


• The Royal College of Occupational Therapists’ Publications Group and supporting
officers Julia Roberts, Quality Programme Manager, and Tessa Fincham, Publications
Manager

* The development and publication of the 1st edition of the practice guideline was funded by the College of Occupational
Therapists and the COT Specialist Section – Rheumatology (now part of the RCOT Specialist Section – Trauma and
Musculoskeletal Health).

­78 Hand and wrist orthoses for adults with rheumatological conditions
Appendix 3: Conflicts of
interest declarations

Declarations were made in line with the conflicts of interest procedures (Section 9.6), as
follows:
• All members of the core guideline development group and five members of the
guideline review group were members of the Royal College of Occupational Therapists
Specialist Section – Musculoskeletal Health.
• Three members of the guideline development group and one co-opted critical
appraiser were authors or co-authors of evidence, or contextual grey literature,
included within the guideline. Careful allocation of abstracts and articles for screening
and critical appraisal, and the consensus approach taken in the guideline
development meetings, meant there was no undue bias from any authorship.
• Two members of the guideline review group identified their roles in research activities.
• The co-opted Editorial Lead in the first and second editions was an Officer of the Royal
College of Occupational Therapists.
• Two of the co-opted critical appraisers in the first edition were officers of the Royal
College of Occupational Therapists. All evidence was appraised by two individuals, and
allocations ensured that these officers were ‘paired’ with an appraiser not employed
by the College.
• Guideline group members, co-opted critical appraisers and occupational therapists
involved in the consultation activity identified their membership of one or more
professional organisations or specialist rheumatology-related fora, which included the
Royal College of Occupational Therapists; Royal College of Occupational Therapists
Specialist Section – Trauma and Musculoskeletal Health; British Association of Hand
Therapists; Association of Occupational Therapists of Ireland; Scottish Society for
Rheumatology; British Health Professionals in Rheumatology; and the Chartered
Society of Physiotherapy.
• Stakeholder and peer reviewer declarations included involvement in rheumatology-
related fora or specialist interest groups, research activities, and authorship of
publications pertinent to the guideline topic.

The nature of declarations made by all those involved in the guideline development was
related to professional interests and expertise in clinical practice, education or research.

There were nil conflicts of interest declared by people who access services, other than
personal experience of a rheumatological condition(s).

No commercial or financial interests were declared.

The adherence to the Royal College of Occupational Therapists’ conflicts of interest


policy, and the nature and management of the above declarations, together with the
robust guideline development methodology, mean that the potential for any bias has
been taken into account and mitigated.

Royal College of Occupational Therapists 2020


­79
­80

Appendix 4: Literature search strategy (1st edition)

Table A1: Search terms and strings

Term string set 1: Term string set 2: Term string set 3: Term string set 4: Term string set 5: Term string set 6: Additional
Condition/problem Alternative conditions to Limb-related terms Intervention Occupational terms to narrow specifically
be searched only with therapy terms for cost
Term string set 1

rheumato* OR synov* OR hand* OR splint* OR occupational therap* econom* OR


rheumatism OR trigger finger* OR wrist* OR brace* OR OR cost* OR
arthrit* OR trigger thumb* OR thumb* OR bracing OR physiotherap* OR financ* OR
osteoarthrit* OR carpal tunnel syndrome OR finger* OR thermoplastic* OR orthotist* OR money OR
psoriatic arthrit* OR dactylitis OR digit* OR lycra OR physical therapist* OR monies OR
inflammatory sausage finger* OR carpal* OR neoprene OR ergotherapist* hand saving* OR
Hand and wrist orthoses for adults with rheumatological conditions

arthropath* OR swan neck OR metacarpal* OR oedema glove* OR therap* resource* OR


degenerative Boutonniere OR radiocarpal OR edema glove* OR staff*
arthropath* OR mallet finger* OR distal radioulnar OR orthos* OR
inflammatory arthrit* ulnar deviation OR phalangeal OR orthotic* OR
OR Z thumb OR interphalangeal OR compression glove* OR
degenerative arthrit* Z-thumb OR inter-phalangeal OR isotoner glove* OR
OR tendon rupture* OR TFCC OR prefabricated OR
rheumatoid arthrit* de Quervain* OR triangular fibrocartilage pre-fabricated OR
OR tendinopath* OR complex elastic* OR
lupus sublux* OR comfortprene OR
erythematosus OR deform* off the shelf OR
joint inflammation off-the-shelf OR
wrist wrap* OR
thumb wrap* OR
wrist cuff* OR
Oval 8 OR
Oval-8 OR
Futuro OR
spica
Appendix 4: Literature search strategy (1st edition)

Table A2: Database search strategy


A title/abstract/descriptor search was undertaken for the various search string
combinations.

Key:

ab = abstract de = descriptors hw = heading words id = key words


kw = keyword sh = subject heading su = subject ti = title

Database or platform and search date


Cochrane EBSCO Ovid PubMed
22/05/14 20/05/14 16/05/14 15/05/14
Search term strings (below) ti, ab, kw TI, AB, SU ti, ab, de, ti, ab
and fields searched (right) hw, id, sh
Strings: 1 AND 2 AND 3 AND 4 57 27 4 65
AND 5
Strings: 1 AND 3 AND 4 AND 5 20 92 35 198
Strings: 1 AND 2 AND 3 AND 4 4 8 2 10
AND 6
Strings: 1 AND 3 AND 4 AND 6 6 21 5 27
Strings: 1 AND 2 AND 4 31 295 83 635
Strings: 1 AND 2 AND 3 AND 4 15 98 22 204
Strings: 1 AND 3 AND 4 45 330 88 599
Strings: (1 AND 4) OR (2 AND 4) 6
OR (4 AND 5) *
Total results 184 871 239 1738
Removed via platform de-duping 412 96 1317
and/or filter options (date/
language)
Total for cleansing/screening 184 459 143 421

* These broad searches were not used as a default during searching as too many non-
relevant results would have been returned, but were used for the Cochrane Database results.

MEDLINE, CINAHL – accessed via EBSCOHOST platform

AMED, HMIC, PsycINFO, Social Policy and Practice – accessed via Ovid platform

Royal College of Occupational Therapists 2020


­81
Appendix 4: Literature search strategy (1st edition)

Table A3: Specialist searches


Database or Fields Terms Number Date of
platform retrieved search
OT SEARCH ti OR su String 4 – intervention terms 39 21/05/14
OTseeker ti AND kw Individual terms from: 158 16/05/14
String 4 [ti] AND (string 1 [kw] OR
string 2 [kw] OR string 3 [kw] OR
(string 5 [kw] OR string 6 [kw]))
String 5 [ti]

OTDBASE Topic search Orthotics (AND terms finger; 408 13/05/14


and subtopic hand; wrist; arm; theory/research) 14/05/14
terms Physical condition (AND terms
arthritis; finger)
Hands (AND function; theory/
research; –therapy)
String 4 – individual terms [ti]

ProQuest ti OR su String 4 – intervention individual 44 10/06/14


term searches
Ethos ti OR String 4 – intervention individual 66 02/06/14
secondary term searches
title fields
Handsearch N/A Terms from strings 2, 3, 4 27 15/07/14
COT Library All fields String 4 – intervention individual 47 13/05/14
term searches
Websites N/A String 4 – intervention terms and 73 30/04/14
browsing of identified sites
String 3 – limb-related terms and
browsing of identified sites

­82 Hand and wrist orthoses for adults with rheumatological conditions
Appendix 5: Literature search strategy (2nd edition)
Royal College of Occupational Therapists 2020

Table A4: Monitoring search and full review search terms and strings
For the monitoring searches, Ovid was searched in the descriptor/subject heading, while EBSCO was searched in the title, abstract and
subject.

For the full review search, Ovid and EBSCO platform terms were searched in title, descriptor/subject heading fields and abstract.

Term string set 1: Term string set 2: Alt Term string set 3: Term string set 4: Term string set 5: Term string set 6:
Condition/problem conditions to be Limb-related terms Intervention Occupational therapy Additional terms to
searched only with terms narrow specifically for
Term string set 1 cost
rheumato* OR synov* OR hand* OR splint* OR occupational therap* OR econom* OR
rheumatism OR trigger finger* OR wrist* OR brace* OR physiotherap* OR cost* OR
arthrit* OR trigger thumb* OR thumb* OR bracing OR orthotist* OR financ* OR
osteoarthrit* OR carpal tunnel syndrome finger* OR thermoplastic* OR physical therapist* OR money OR
psoriatic arthrit* OR OR digit* OR lycra OR ergotherapist* OR monies OR
inflammatory arthropath* dactylitis OR carpal* OR neoprene OR hand therap* saving* OR
OR sausage finger* OR metacarpal* OR oedema glove* OR resource* OR
degenerative arthropath* swan neck OR radiocarpal OR edema glove* OR staff*
OR inflammatory arthrit* Boutonniere OR distal radioulnar OR orthos* OR
OR mallet finger* OR phalangeal OR orthotic* OR
degenerative arthrit* OR ulnar deviation OR interphalangeal OR compression glove* OR
rheumatoid arthrit* OR Z thumb OR inter-phalangeal OR isotoner glove* OR
lupus erythematosus OR Z-thumb OR TFCC OR prefabricated OR
joint inflammation tendon rupture* OR triangular pre-fabricated OR
de Quervain* OR fibrocartilage elastic* OR
tendinopath* OR complex comfortprene OR
sublux* OR off the shelf OR
deform* off-the-shelf OR
wrist wrap* OR
thumb wrap* OR
wrist cuff* OR
Oval 8 OR
Oval-8 OR
Futuro OR
spica
­83
Appendix 5: Literature search strategy (2nd edition)

Tables A5 and A6: Monitoring search strategy


The following table shows EBSCO (MEDLINE, CINAHL) and Ovid (AMED, HMIC, PsycINFO,
Social Policy and Practice) platform searches from monitoring searches, which covered
the periods from 2014–2017. The first monitoring search (2015–2016) replicated the first
edition full guideline search, while the second set of monitoring searches (from 2016)
used a condensed approach to ensure no studies were published that required an
immediate change to the recommendations. A full review search, which covered the
period from 2014–2018, replicated the first edition guideline literature search.

Table A5: Monitoring search (2015–2016)

Platform and search date


Search strings EBSCO Ovid –
–24.05.16 24.05.16
1 AND 2 AND 3 AND 4 3 0
AND 5
1 AND 3 AND 4 AND 5 16 1
1 AND 2 AND 3 AND 4 2 0
AND 6
1 AND 3 AND 4 AND 6 9 0
1 AND 2 AND 4 64 2
1 AND 2 AND 3 AND 4 16 1
1 AND 3 AND 4 72 7
Removed via platform 62 3
deduping
Total 120 8

­84 Hand and wrist orthoses for adults with rheumatological conditions
Appendix 5: Literature search strategy (2nd edition)

Table A6: Monthly monitoring searches (from 2016)

Platform and search date


Search strings EBSCO – Ovid –
monthly monthly
from 2016 from 2016

1 AND 2 AND 3 AND 4 0 0


AND 5
1 AND 3 AND 4 AND 5 0 1
1 AND 2 AND 3 AND 4 6 0
AND 6
1 AND 3 AND 4 AND 6 0 0
1 AND 2 AND 4 0 0
1 AND 2 AND 3 AND 4 0 0
1 AND 3 AND 4 0 1
Total 6 2

Tables A7 and A8: Full review search strategy


Tables A7 and A8 show the search strings and platforms/databases used in the full
review search, which covered 2014–2018 and replicated the original first edition
guideline literature search.

MEDLINE and CINAHL were accessed via the EBSCO platform while AMED, HMIC,
PsycINFO, Social Policy and Practice were accessed via Ovid.

Royal College of Occupational Therapists 2020


­85
Appendix 5: Literature search strategy (2nd edition)

Table A7: Full review search – database searches

Platform and search date


Cochrane – EBSCO – Ovid – PubMed
01.10.18 and 03.10.18 01.10.18 – 03.10.18
03.10.18
Search strings title, title, subject, title, subject title,
(below) and fields abstract, key abstract heading, abstract
searched (right) word descriptor,
abstract,
heading
words
1 AND 2 AND 3 AND 4 15 8 1 10
AND 5
1 AND 3 AND 4 AND 5 62 37 10 27
1 AND 2 AND 3 AND 4 9 6 2 4
AND 6
1 AND 3 AND 4 AND 6 27 16 4 11
1 AND 2 AND 4 42 121 19 0
1 AND 2 AND 3 AND 4 24 34 9 37
1 AND 3 AND 4 104 167 38 0
(1 AND 4) OR (2 AND 103
4) OR (4 AND 5)*
Removed via platform 0 159 35 0
deduping
Total 386 230 48 89

* These broad searches were not used as a default, as too many irrelevant results would have
been returned across all databases, but were used for searching the Cochrane Database.

­86 Hand and wrist orthoses for adults with rheumatological conditions
Appendix 5: Literature search strategy (2nd edition)

Table A8: Specialist database searches

Database or Fields Terms Number Date of


platform retrieved search

OT SEARCH Title or String 4 – intervention terms 9 04.10.18


subject
OTseeker Title, Individual terms from: 218 04.10.18
abstract, Strings 2, 3, 4, and 5
keywords
OTDBASE Topic Orthotics (AND terms finger; 94 04.10.18
search hand; wrist; arm; theory/research)
and title Physical condition (AND terms
arthritis; finger)
Hands (AND function; theory/
research; –therapy)
String 4 – individual terms in title

RCOT All fields String 4 – intervention individual 6 04.10.18


newsletters search terms
UK National Title String 4 – intervention individual 5 05.10.18
PhD Theses term searches
String 1 – condition individual
term searches (Rheumatoid
arthritis, rheumatism OR
rheumatological, arthritis)
Hand-search All fields Terms from strings 1, 3, 4 7 03.10.18
of the RCOT
library
catalogue
NHS EED Title String 4 49 03.10.18
Medicines Keywords String 4 2 08.10.18
and
Healthcare
Products
Regulatory
Agency
Websites N/A String 4, and Strings 3 and 4 for 65 05.10.18
National Institute for Health
Research (NIHR) website

Royal College of Occupational Therapists 2020


­87
Appendix 6: Evidence tables
­88

Source Design and participants Intervention Outcomes Results Quality and comment

Adams et Randomised controlled trial Intervention group: Measures taken at Analysis included 56 in intervention Grade B – Moderate
al (2008) static resting splint plus standard baseline prior to group and 60 in control group
Aim: to evaluate the occupational therapy intervention randomisation and at 12 Downgraded from A due to
effectiveness of static resting months Adherence to splint wear was self- limitations:
splints in early RA Static resting splint of low- reported and moderate. Ranged • Cannot say that further
temperature thermoplastic: Primary outcome: from 12 participants (24%) who research is unlikely to change
Prospective multicentre single forearm prone position wrist • Grip strength – MIE never wore splint to 12 (24.5%) who confidence in the treatment
blinded design neutral digital grip analyser wore splint >48 hours/week effect size and direction
MCPJ flexion maximum 60° IPJ
Eight participating centres, flexion 30° Secondary outcomes: 47 (84%) participants perceived Comments:
occupational therapy Thumb mid position, palmar • Structural impairment splint to be effective; 12 (25.5%) • Targeted participants with
department referrals abducted – summary scores of the viewed it as not effective at all early RA – may have been too
dominant hand MCPJ early for participants to have
Inclusion: over 18 years, Control group: ulnar deviation Grip: no significant difference in grip adjusted to diagnosis and be
confirmed diagnosis of RA, standard occupational therapy deformity (goniometry strength data between groups or in ready to commit to self-
duration <5 years intervention readings) percentage of change over 12 management behaviours, e.g.
• Hand function – applied months wearing splints
Exclusion: hemiparesis, from a Written and verbal instruction dexterity test (button • Follow-up at 12 months may
Hand and wrist orthoses for adults with rheumatological conditions

vulnerable group, severe given regarding wearing times board) from the Arthritis Ulnar deformity: no significant be too short to show some
cognitive difficulties and care of splint Hand Function Test differences between groups detected longer-term beneficial effects,
Advised to wear during day when • Michigan Hand and lack of follow-up before
120 participants randomized resting and when hands are Outcomes Pain: over 12-month follow-up, 12 months may have failed to
into 2 groups warm, red, tender or swollen, Questionnaire (MHQ) ordinal pain levels showed no capture immediate or short-
increasing wear by 15 minutes – self-report pain and significant differences. Both groups term effects
Splinted group data for 56 per day. Alternative night wear stiffness using 5-point had identical final pain levels • Unexplained discrepancy
Male:female ratio = 14:42 encouraged to start. Follow-up rating scale for pain, between high level of
Mean age (standard deviation telephone calls made at 1 week and a 6-point scale for Hand stiffness: splint appeared to participant-perceived
– SD) = 59.61 years (12.35) and 1 month by occupational early morning wrist and contribute towards reducing early effectiveness in those who
Mean disease duration (SD) = therapist hand joint stiffness morning stiffness; however, where wore splints and objective
8.64 months (8.96) participants reported early morning outcome measures
Standardised occupational Compliance – 7-point stiffness still present after 12 • Design of splint used in trial
Control group data for 60 therapy intervention: ordinal questionnaire for months, the control group showed ‘followed a moderate intrinsic
Male:female ratio = 18:42 1:1 education and practice of estimated hours splint duration was significantly lowered plus position’
Mean age (SD) = 55.22 years joint protection plus hand and worn per week • Results of effectiveness may
(14.62) wrist exercises with provision of Control group improved in almost all be confounded by
Mean disease duration written booklets, activities of Perceived effectiveness outcomes compared with compliance.
(SD) = 12.37 months (13.12) daily living (ADL) assessment, – 5-point ordinal scale intervention group
provision of assistive devices as (where 1 = not at all and 5
United Kingdom. required, plus provision of other = very). Use of a resting splint in early RA did
wrist or hand splints as indicated. not show improvement in grip, pain,
function or deformity of the hand.
Royal College of Occupational Therapists 2020

Source Design and participants Intervention Outcomes Results Quality and comment
Aebischer Systematic review • Splints • Pain Narrative analysis showed the Grade B – Moderate
et al (2016) • Exercise • Function following:
Aim: to review the evidence on • Multimodal interventions • Pain reduction seen in 26 studies, Downgraded due to:
the effectiveness of • Joint protection No studies examined with all splints effective regardless • Most studies were of poor
physiotherapy and • Laser quality of life. of make or design quality and heterogeneity was
occupational therapy on pain, • Acupuncture • Function improved in 24 studies. high across studies.
function and quality of life • Nettle sting One study using a custom-made
• Neurodynamic mobilisation thermoplastic splint and one using Comments:
Inclusion: randomised and • Manual therapy. a long custom-made thermoplastic • Data were missing or
quasi-randomised controlled splint did not show function contradictory to conclusions
trials (RCTs), systematic improvement in some studies and there
reviews, observational, • Interventions that included were indications of reporting
pragmatic and case control exercises with or without splints, bias in some
studies in English, German, multimodal intervention and nettle • Elevated risk of bias in the
French or Dutch, participants sting improved both outcomes. studies means results should
had diagnosis of primary Joint protection, neurodynamic be interpreted conservatively
trapeziometacarpal mobilisation, manual therapy and • Meta-analysis was conducted
osteoarthritis (TMC OA) acupuncture improved pain. Laser where studies had enough
did not improve pain homogeneity in key factors
Exclusion: studies with • Limitations included not
participants under 18 years Meta-analysis of 5 studies (332 systematically searching for
old, not having physiotherapy participants) comparing effect on unpublished trials and
or occupational therapy pain of prefabricated neoprene language restrictions.
interventions splints versus custom-made
thermoplastic splints found no
No date limitations difference (standardised mean
difference [SMD]=−0.01, CI=−0.43,
27 studies included 0.4, p=0.95)
10 RCTs
7 parallel group studies Meta-analysis of 4 studies (175
5 cross-sectional design participants) comparing multimodal
studies interventions to reduce pain versus a
3 observational studies control showed a very high size
2 retrospective studies. effect favouring the intervention
(SMD=−3.16, CI=−5.56, −0.75, p=0.01)

Meta-analyses comparing
multimodal interventions on function
versus control showed high effect
without statistical significance.
­89
­90

Source Design and participants Intervention Outcomes Results Quality and comment
Almeida et Literature review 8 randomised controlled trials All evaluated hand 12 studies showed significant Grade B – Moderate
al (2017) (RCTs) and 6 controlled clinical function (via the improvement in hand function
Aim: to understand impact of trials Disabilities of the Arm, Downgraded due to:
different thumb orthosis Shoulder and Hand [DASH, 1 study showed better hand function • Small number of papers and
designs on pain, hand 7 examined only custom-made 6 studies], other results with a prefabricated, hand- was a literature review, not a
strength and hand function on orthoses, 5 compared custom- standardised based neoprene orthosis compared systematic review
people with carpometacarpal made with prefabricated models, questionnaire [6 studies], to a custom-made, thermoplastic
osteoarthritis (CMC OA) and 2 looked at off-the-shelf and questionnaire written one, 2 studies showed better results Comments:
orthotics by authors [2 studies]) and with short, hand-based orthosis • Authors suggest short, hand-
Inclusion: use of orthotics on pain (via visual analogue compared to a long, forearm-based based orthoses providing
people aged 18 and older with 5 RCTs had control groups with scale [11 studies], numeric one, and 1 study showed better adequate stabilisation to the
diagnosed thumb CMC OA, alternative treatments or no rate scale [2 studies], results with a soft orthosis compared CMC without immobilising
reported at least one treatment, while 3 RCTs and 4 Australian/Canadian Hand to a rigid one adjacent joints may best
functional outcome via a clinical controlled trials had 2 or Osteoarthritis Index [1 reduce pain
standardised assessment, had more orthoses in independent study], Pain Anxiety 12 studies found orthoses • Limitations include only
a description of the chosen groups, and 2 studies had Symptoms Scale [1 study] significantly decreased pain at the including studies published in
orthotic design, published in different orthoses in the same and Pain Catastrophizing CMC joint, 1 did not and 1 study did English and not evaluating the
English group at different times Scale [1 study]) not report a comparison quality of each study.

Exclusion: studies reporting on Orthotic use ranged from 7.7 to 9 evaluated hand grasp Orthotic design comparisons were
people who underwent 13 hours a day, with total and 14 evaluated pinch inconclusive:
surgery duration ranging from 2 weeks to strength (both via the • 4 studies did not show significant
Hand and wrist orthoses for adults with rheumatological conditions

12 months Jamar® and/or pinch differences in pain modification


14 studies. gauge dynamometers [9 • 2 found better results with hand-
Wearing instructions varied studies], Grippit™ based, custom-made designs only
across studies. Electronic Instrument [2 involving the CMC joint compared
studies], Greenleaf Solo to a prefabricated neoprene
System Pinchmeter [2 orthosis
studies], non-described • 1 study showed less pain with a
electronic dynamometer [1 prefabricated neoprene orthosis
study]). compared with a rigid
thermoplastic design

7 studies reported improvements in


hand grip and pinch strength while 6
showed no difference and 1 showed
a decrease in strength

Wearing instructions did not


influence functional outcome.
Royal College of Occupational Therapists 2020

Source Design and participants Intervention Outcomes Results Quality and comment

Bani et al Cohort study Custom-made short neoprene Measures completed at Mean orthosis use: 7.9 hours per Grade C – Low
(2014) thumb CMCJ orthosis fabricated baseline, 30, 60 and 90 day
Aim: to analyse the effect of a with neoprene material days Comment:
custom-made neoprene reinforced with a thermoplastic Pain: decrease observed after 30 • Unclear sampling methods
thumb carpometacarpal component formed in a ‘U’ shape Pain: VAS (100 mm) days (p=0.003), and continued to – no information provided on
orthosis with thermoplastic around the CMCJ for stabilisation Function: Disabilities of improve during treatment with the recruitment, therefore unable
stabilisation on pain, function, of the joint the Arm, Shoulder and splint (at 90 days p<0.001) to make a judgement as to
grip strength and key pinch Hand (DASH) representation and inclusion
Wrist and MCP joints left free questionnaire Function: DASH scores significantly • Small sample size
Mild to moderate OA of improved between baseline and • No control group
carpometacarpal (CMC) joints Participants were instructed to Grip and pinch strength: each of the 30-, 60- and 90-day • No hand function assessment
of the thumb (Grade 1 or use orthosis when they Jamar® Hydraulic periods (at 90 days <0.001) • Limited statistical analysis of
Grade 2) with joint pain experienced symptoms and for Dynamometer and pinch results
ADLs gauge – average of three Grip and pinch strength: after 90 • No reference to grade of OA
Inclusion: no deformity of scores. days of using the splint, grip strength for each participant – could
affected hand, no previous Orthosis used for maximum of 3 and pinch strength were improved this affect levels of pain, grip
surgery or injection during months. compared with baseline (p<0.001) strength, function?
preceding 6 months, no • Specific wearing regimens not
allergy to splint materials Pain, function and pinch strength outlined (e.g. for how long,
maintained significant differences how often)
Exclusion: other disease that between 30 and 60 days, and • No discussion of how they
might cause similar pain (such between 60 and 90 days. Although it measured splint use over the
as carpal tunnel syndrome was initially improved, no significant study period, e.g. splint diary
(CTS), De Quervain’s difference was demonstrated for • Neither subjects nor assessor
syndrome, Dupuytren’s grip strength for the duration of the blinded – unable to, as only
contracture, arthritis, or fifth/ use of the orthosis. one cohort and subjects knew
sixth cervical disc herniation), they were using the splint
no pain or stiffness in the • Did not look at any harmful
shoulders or glenohumeral effects/contraindications
joint • No mention of any other
interventions during this
11 participants period which may have
Male:female ratio = 2:9 affected outcomes
Mean age = 55.35 years • No reference to compliance,
comfort, feedback on splint
Iran. from participants.
­91
­92

Source Design and participants Intervention Outcomes Results Quality and comment

Bani et al Cohort repeated measures study Splint to stabilise the first CMC Measures completed at Pain: reduced at 30 days Grade C – Low
(2013a) joint, maintain pulp of distal baseline, 30, 60 and 90 (p<0.001), and continued to
Aim: evaluation of the effect of phalange of index finger free for days reduce at 60 days (p<0.001) Comments:
custom-made splint for the thumb gripping with other fingers, leave and 90 days (p<0.001) • No control
(OA first metacarpal joint) on pain, thumb in functional position Pain: VAS (10 cm) compared with baseline • Small sample size with no
grip, strength and key pinch power calculation related to
Custom-made, low-temperature Function: Disabilities of Function: improved at 30 selection of assessments
Referrals to Orthotics and Prosthetics mouldable thermoplastic material the Arm, Shoulder and days (p<0.001), and DASH • Irregular presentation of
department (1.6 mm thickness, inside lined Hand (DASH) score continued to reduce at results in tables (p=0.000)
with Plastazote® 1.6 mm) 60 days (p<0.001) and 90 compared to text (p<0.001)
Inclusion: clinical and radiological Grip strength: Jamar® days (p<0.001) compared • No loss to follow-up or data
diagnosis of thumb carpometacarpal Use during routine ADL; remove dynamometer with baseline in a study is unusual, but
joint, OA Grade 1 and 2, with pain in to sleep, bath, exposure to heat, possible with small sample
the base of the thumb etc. Lateral pinch: Jamar® Grip strength: significant size
pinch gauge. difference compared with • Volunteers and no description
Exclusion: other deformities of the baseline after 60 days but of how this may affect
affected hand; deformities of the not at 30 days characteristics
distal interphalangeal joint of the • Highly customised splint
thumb; use of a splint on the affected Pinch strength: design, which would be
thumb during the previous 6 months; demonstrated significant difficult to replicate.
surgery on the studied hand during improvement at all timelines
the previous 6 months; potential compared with baseline
Hand and wrist orthoses for adults with rheumatological conditions

allergy to the splint material; an


inability to respond to a Improvement in pain scores
questionnaire, or to perform the tests 30 days post wearing of
due to communication difficulties; splint and continuous
evidence of injection therapy in the improvement throughout
studied hand in the previous 6 measurement period
months; presence of additional
disease affecting the ipsilateral upper Grip, pinch and function all
limb (e.g. carpal tunnel syndrome, De improved after 90 days of
Quervain’s tendonitis, Dupuytren’s wearing of orthosis.
contracture, arthritis, and fifth and
sixth cervical vertebral disc herniation)

18 participants
Male:female ratio = 3:15
Mean age = 56.06 years

Iran.
Source Design and participants Intervention Outcomes Results Quality and comment
Royal College of Occupational Therapists 2020

Bani et al Randomised controlled trial Intervention group: splint Measured at Pain: significantly reduced (p=0.000) at end Grade A – High
(2013b) to stabilise the first baseline and 4, 6 of week 4, whether wearing prefabricated
Aim: to compare the effect of CMC joint, maintain pulp and 10 weeks splint or custom-made splint. Prefabricated Comments:
prefabricated and custom-made of distal phalange of index splint and the custom-made splint both • Cross-over design – issues
thumb splints on pain, function, grip finger free for gripping Pain: VAS significantly reduced pain compared with around carryover effects
strength and key pinch in basilar joint with other fingers, leave the control group at the end of the tenth • No sample size calculation
OA thumb in functional Function: Disability week (both p=0.000) • Small study
position of the Arm, Comparing the two splints, significant • Limited follow-up period
Recruitment from Tehran Orthotics Shoulder and Hand differences were noted in pain levels • Limited details of the splints
and Prosthetics department, referred Intervention splint 1: (DASH) (p=0.024) at 10 weeks; a better • No reports of any harmful
by orthopaedic surgeon. Assigned prefabricated thumb CMC performance in pain reduction was effects
randomly to 3 groups – cross-over splint (covered first CMC Grip strength: reported for the custom-made splint at the • No costing given re splint,
study with a control group and metacarpophalangeal Jamar® end of the study period therapist time
joints allowing full range of dynamometer • No blinding – participants,
Inclusion: clinical and radiological motion in other fingers, Function: at the end of week 4, therapists or evaluator.
diagnosis of OA Grade 1 and 2 first material thickness 3.5 mm) Lateral pinch: prefabricated splint demonstrated increase
CMC joint, evidence of pain in the Jamar® pinch in DASH score (p=0.018) but custom-made
base of the thumb Intervention splint 2: gauge. splint had no significant improvement
custom-made CMC thumb compared to control group. Both splints
Exclusion: other hand deformities of splint (low-temperature significantly increased function at end of
the affected hand; deformity of thumb moulding material, 1.6 mm tenth week (p=0.000) compared with
interphalangeal (IP) joint; use of a thickness, inside lined with control group. No significant difference
splint on the thumb during the Plastazote® 1.6 mm) between two splints identified
previous 6 months; evidence of
surgery on the studied hand in the Use during routine ADL; Grip strength: positive effect from both
previous 6 months; allergy to the remove to sleep, bath, splints but neither demonstrated
splint material; inability to respond to exposure to heat, etc. significant improvement at end of 4 weeks
a questionnaire or to perform the or end of 10 weeks, and no significant
functional tests; evidence of injection One splint was worn for 4 difference between the two splints
therapy in the studied hand during the weeks, followed by a
previous 6 months; existence of other 2-week washout period, Pinch: increased at end of 4 weeks for both
disease affecting the thumb or wrist then the second type of prefabricated (p=0.000) and custom-made
splint was worn for 4 splint (p=0.001), and also at end of 10
35 volunteer participants (11 in weeks weeks (both p=0.000). No significant
control group and 12 in each of the difference determined between the two
other intervention groups) Control group: splints
Follow-up period of 10
Male:female ratio per group: weeks. In the control group, pain increased and
• Prefabricated splint = 4:8 pinch strength decreased, but no
• Custom = 3:9 statistically significant differences were
• Control = 3:8 found in function and grip strength

Age range average per group: The prefabricated and custom-made


• Prefabricated splint – 53.42 years splints both reduced pain, with the custom-
• Custom – 54.91 years made splinting being more effective.
• Control – 58.64 years Function and pinch strength also increased,
but grip strength was not improved.
­93

Iran.
Source Design and participants Intervention Outcomes Results Quality and comment
­94

Becker et Randomised controlled trial Splint provided by an Measures at baseline, and the 62 completed the study: 32 Grade B – Moderate
al (2013) occupational therapist majority also at 5–15 weeks neoprene splint and 30 thermoplast
Aim: to compare two splints splint Downgraded from A due to
for trapeziometacarpal Splint 1: Primary outcome limitations:
arthrosis: a neoprene and a prefabricated neoprene • Arm-specific disability – DASH 51 participants did not return for the • Superiority trial – cannot
thermoplast hand-based Comfort Cool® Thumb CMC second visit and 6 did not complete conclude that splints are
thumb spica splint Restriction Splint (North Other outcome measures: the protocol for other reasons equivalent, only that there is
Coast Medical) • Pain Anxiety Symptoms Scale no evidence that one is better
Null hypothesis: no difference (PASS) Similar improvements seen between than the other
in arm-specific disability 5–15 Splint 2: • Pain Catastrophising Scale the two groups for pain, grip and • Reliance on clinical rather
weeks after prescription of a customised 3.2 mm thick (PCS) pinch strength than radiological diagnosis
prefabricated neoprene splint thermoplastic hand-based • Centre for Epidemiological • Research assistant not
or a similar custom-made thumb spica splint with Studies Depression Scale Average arm-specific function did not blinded to randomisation
thumb spica made from metacarpophalangeal (CES-D) change • Large dropout numbers
thermoplastic included and the IP joint and • Whiteley Index (n=57)
wrist free • Pinch – B&L Engineering There were no detectable differences • Some participants received
Outpatient office of two hand Pinch Gauge® in DASH score, change in DASH, pain, other splints or changed from
surgeons at a tertiary care Regimen: wear the splint as • Grip strength – Jamar® satisfaction, pinch or grip strength one type to the other
hospital needed for pain relief with dynamometer between the two splint types in the • DASH scores included even if
daily activities and at night if • Ordinal scale for pain – 0 (no sample greater than 3 items missing
Equally randomised (1:1) to it helped them sleep pain) to 10 (worst pain you • Three participants completed
wear either splint ever had) Neoprene group rated comfort protocol later than the
Hand and wrist orthoses for adults with rheumatological conditions

Splint adjustments were higher (p=0.048) – this was the only accepted timeframe
Inclusion: 18 years or older, allowed. Satisfaction scale for splint – six significant difference between the • No specific information given
clinically diagnosed with 11-point ordinal satisfaction two splints on how or when the
trapeziometacarpal arthrosis scales asked at follow-up for: participants actually used the
by the hand surgeon, English- 1. Satisfaction with the splint Satisfaction appeared high splints, or if any harmful
speaking 2. How the splint helped in effects were reported.
terms of pain Suggestion that prefabricated
Exclusion: history of surgically 3. How the splint helped in neoprene thumb spica splints were
treated trapeziometacarpal keeping active, doing daily on average cheaper (but no costs
arthrosis living activities provided), more comfortable and as
4. If the splint improved quality effective as a custom-made
119 participants with 62 of life thermoplastic splint.
completing: 5. How comfortable wearing
Male:female ratio = 14:48 the splint was
Mean age (SD) = 63 years (8.1) 6. How easy it was to follow the
hand therapist’s instructions
United States of America. regarding splint use
A higher score indicated greater
satisfaction or help.
Royal College of Occupational Therapists 2020

Source Design and participants Intervention Outcomes Results Quality and comment
Bertozzi et Systematic review Interventions focused on: Outcome measures Results for interventions focused on Grade B – Moderate
al (2015) • Therapeutic exercise (n=4) included: splints included:
Aim: to review evidence from • Manual therapy (n=4) • Pain (n=16) • Moderate quality evidence (n=3) Downgraded due to:
randomised controlled trials • Therapeutic exercise and • Hand strength (n=11) indicates that splints can improve • Low-quality evidence in
(RCTs) on the effect of manual therapy (n=1) • Function (n=7) function at long-term follow-up regard to splints
conservative interventions on • Laser therapy (n=1) • Stiffness (n=6) • Low-quality evidence (n=2) that
pain and function in those • Magneto therapy (n=1) • Range of motion (n=4). splints did not significantly Comments:
with thumb carpometacarpal • Splints (n=3) improve function at short-term • Much of the evidence was low
(CMC) osteoarthritis (OA) • Multidisciplinary treatment follow-up quality.
programme (n=1) • Low-quality evidence (n=2) that
Inclusion: published RCTs with splints provide no significant
participants diagnosed with Control groups consisted of no improvement in pain at short- and
CMC OA, symptomatic and 18 treatment, sham protocol, normal long-term follow-ups
years or older using common activities, placebo and joint • Moderate quality evidence (n=2)
rehabilitative interventions protection and education-only that splints provide significant
and assessed at least one programme. improvement in hand strength at
primary outcome short-term follow-up, but low-
quality evidence (n=2) for
Exclusion: quasi-RCTs, non- significant improvement at long-
randomised trials, evaluations term follow-up
of surgical or pharmacological • Low-quality evidence (n=1) that
interventions splints did not significantly
improve hand stiffness in long-
Databases were searched term follow-up
from inception to May 2014 • Low-quality evidence (n=1) that
splints did not significantly
16 studies included. improve range of motion in long-
term follow-up.
­95
­96

Source Design and participants Intervention Outcomes Results Quality and comment

Boer Multicentre cross-sectional Functional wrist orthoses Semi-structured interview: 128 participants possessed a functional Grade C – Low
et al (2008) study (custom-made • Hand and wrist complaints, wrist splint
thermoplastic or ADL, pain, swelling and Comments:
Aim: to examine possession commercial fabric with tingling in the wrist and hand 58% (n=74) were using the splint • Results are convincing due
and usage of functional wrist steel reinforcement). • Possession and prescription to large effect reported;
orthoses in a Dutch population process 54 participants (42%) had not used the however, questionnaire
• Usage – category on 8-point orthoses at all design not a recognised
Random selection of scale of never to always and validated source;
participants from outpatient • Activities undertaken when Activity use: housekeeping activities cultural differences with
clinics at three rheumatology wearing the splint (39%), cycling/driving (30%), resting activities chosen to ask
centres (6 categories) (28%), always (20%), work and leisure about, e.g. cycling, may not
• Individual reasons for usage activities (varying between 2% and 8%) apply to guideline
Inclusion: clinical diagnosis of and for non-usage population
RA according to the 1987 Rates of prescription varied among • 90% of participants had
American College of Questionnaire and clinical three centres but did not reach costs reimbursed by
Rheumatology (ACR) criteria assessment: statistical significance insurance company, with
from medical records; fluent in • Disease characteristics – significant differences
Dutch Dutch Arthritis Impact Reasons for use: relief of pain/swelling between the three locations
Hand and wrist orthoses for adults with rheumatological conditions

Measurement Scale II (AIMS (n=65/74) and joint protection (n=49/74) • Recruitment bias possible.
Exclusion: not stated II), Disease Activity Score
(DAS28), VAS (100 mm) for Reasons for non-use: no need;
240 participants out of 362 pain and fatigue problems with ease of use; plus
eligible • Physical and mental comments on lack of fit or comfort;
functioning – RAND-36 potential ‘harmful effect’ of a wrist
Male:female ratio = 55:185 Health Survey orthosis (not defined)
Median age (interquartile • Coping – Coping with
range): 63 years (18) Rheumatic Stressors (CORS) Factors significantly associated with
• Participant satisfaction: usage included the presence of wrist
Netherlands. Dutch version of Quebec and hand complaints, worse physical
User Evaluation of functioning (RAND-36) and greater
Satisfaction with Assistive satisfaction with comfort of the wrist
Technology (D-QUEST). orthoses.
Royal College of Occupational Therapists 2020

Source Design and participants Intervention Outcomes Results Quality and comment

Boustedt et Parallel trial Intervention group (SE): Assessments at: Five dropouts at follow-up so Grade C – Low
al (2009) JP programme with addition of • Baseline (1 week analysis data for 35
Aim: to examine the effect of an splints, hot pack and home before start of the participants Comments:
extended joint protection (JP) exercise intervention) • Not randomised study and
programme with splint and exercise (SE • 1 week after the Intervention group wearing no control group/non-
group) compared with the standard JP Regimen: splints 24 hours per day 5-week JP programme splint had significant splinted group
programme (control group) combined with daily home • Follow-up (1 year after decrease in pain, stiffness • Study does not provide
exercise, as well as the JP the intervention) and an improvement in daily evidence for use of
Referred by a physician programme activities directly after the particular splints in thumb
Primary outcome intervention (p=0.034; OA, but does provide
Inclusion: women with either clinically Night: custom-made • Grip force – GrippitTM p=0.014; p=0.007) and at context for their use
and/or X-ray diagnosed hand OA, who thermoplastic forearm splint 1-year follow-up (p=0.012; • DASH does not identify fine
had experienced any kind of pain in the Secondary outcome: p=0.012; p=0.003) compared motor activity problems –
CMC-1 joints, not specified to a certain Day: prefabricated elastic thumb • ADL difficulties – DASH with the control group common in base of thumb
level of pain, and not been in a JP splint and/or custom-made (work and leisure OA
programme group earlier thermoplastic thumb splint at all items not used) Control group decreased in • Not all constructs of the
times, using a hot pack for 15 • Pain and stiffness – pain on motion and DASH used, even though 21
Exclusion: women with evidence of RA minutes before hand exercise at VAS (100 mm) for improved in daily activities women worked and assume
or any rheumatic disease other than home, carrying out the same most recent week. just after the intervention, all participated in leisure
OA, and women with carpal tunnel hand exercise with paraffin dough but not at 1-year follow-up activities
syndrome as in the JP programme once a • SE group had slightly
day In the splint intervention shorter duration of
42 participants group pain at night, pain on diagnosis
Two dropped out, so 20 in each Control group: motion, and stiffness • Splinting in evaluation
intervention group JP programme only decreased. Grip force group appears to have been
increased and daily activities day and night except for
All female All participants received standard improved exercise regimen, but no
JP programme provided by information apparent
Extended programme and splint group: occupational therapists: 10 group Suggests that adding regarding compliance or
Median age (range) = 61 years (40–76) educational/behavioural sessions splinting and exercise to a JP any issues with this regimen
Median disease duration (range) = 2 over a period of 5 weeks (groups programme gives greater • Both groups tried elastic
years (1–23) of 4–8 participants). Included improvement of pain, thumb spicas during the
trying out grip assistive devices stiffness, grip force and daily day as part of the JP
Control standard programme group: and elastic thumb splints during activities. programme.
Median age (range) = 61 years (50–76) the day at clinic and home. Also
Median disease duration (range) = 5 included paraffin wax heat
years (1–18) treatment and hand exercise with
paraffin dough.
Sweden.
­97
­98

Source Design and participants Intervention Outcomes Results Quality and comment
Cantero-Téllez et Methodology: prospective, assessor- Randomly allocated into 2 Pain (primary outcome) Mean pain scores reduced Grade B – Moderate
al (2018) blinded study with a randomised design groups measured by VAS from 77 to 46 in the group
whose splint included the Downgraded due to:
Aim: to compare the short-term effect of 2 33 participants fitted with Hand function (secondary MCP joint, and from 77 to • The sample is small,
thumb orthotic designs on pain and hand an orthosis where the outcome) measured by 48 in the group whose splint with little information
function thermoplastic material QuickDASH excluded the MCP joint. about the participants,
included the MCP joint Both are significant effects who was excluded,
Recruitment: referral by orthopaedic hand Both completed 1 day prior (p<0.001), but there are not randomisation, and
surgeon to hand therapy clinic 33 participants fitted with a to beginning the significant differences does not discuss
CMC joint immobilisation intervention and 1 week between the two blinding of the
Inclusion: diagnosis of thumb orthosis that did not after start of intervention. assessors. Outcomes
carpometacarpal osteoarthritis (CMC OA) in include the MCP joint Mean QuickDASH scores measured after only 1
the dominant hand and classified as Grade reduced from 40.2 to 36.1 week of splint wearing.
2 or 3 according to Eaton–Littler All orthoses were custom in the group whose splint
radiological staging protocol, had pain fabricated and participants included the MCP joint, and
intensity during activities of daily living received identical wearing from 41.7 to 35.7 in the
(ADL) >40/100 on the visual analogue scale instructions: use at night group excluding the MCP
(VAS) and during daytime ADL for joint. These were significant
3–4 hours per day effects (p<0.001), but not
Exclusion: neurological disorder affecting significantly different
Hand and wrist orthoses for adults with rheumatological conditions

the upper limb, received treatment/surgery Participants asked to record between groups.
for hand in past 6 months, received an treatment adherence and
intra-articular joint injection to the wrist, any discomfort
fingers or thumb, exhibited thumb
metacarpophalangeal (MCP) No other treatment
hyperextension, scored >4 on the Beck intervention.
Depression Inventory, >30 in the State Trait
Anxiety Inventor, did not complete the
Quick Disabilities of the Arm, Shoulder and
Hand (QuickDASH) or previously received
any type of hand orthosis for this problem

66 participants
Male:female ratio = 1:4
Mean age = 63.7 years

Spain.
Royal College of Occupational Therapists 2020

Source Design and participants Intervention Outcomes Results Quality and comment
Duong et al (2018) Survey of hand therapists Survey adapted from one Survey collected Three-quarters of respondents Grade D – Very Low
used to assess the demographics, had 6+ years of experience in
Aim: to understand attitudes, beliefs management of knee OA experience, expertise and hand therapy Downgraded due to:
and common practices of Australian by physiotherapists in the attitude and beliefs about • Poor response rate with no
hand therapists regarding the United Kingdom. exercise and orthosis A majority completed reporting of qualitative
assessment and management of prescription for base of postgraduate training in hand responses
base thumb osteoarthritis (OA) thumb OA. It then therapy and specific training in
presented a case study manufacturing orthoses Comments:
Recruitment via membership of the and asked about clinical • Limitations include only
Australian Hand Therapy Association assessment and 74% said they would refer the having one case study to
(AHTA) between November 2015 and treatment of hypothetical person in the case study for assess clinical practice
February 2016 person. radiographs of the first • The authors believe the lack
carpometacarpal joint. The most of consensus on orthoses
Inclusion: members of AHTA who commonly used physical type and wear reflects a
had agreed to receive emails from measures were palpitation, range lack of specific evidence-
AHTA and who treated people 45 of motion, grind test and pain based recommendations.
years and older with chronic pain at provoked by opposition of the
the base of the thumb in the last 6 thumb across the palm
months
65% would use questionnaires in
124 respondents – 77 complete and their assessment, with the most
47 partially complete common being the Disabilities of
92 occupational therapists the Arm, Shoulder and Hand
42 physiotherapists (DASH) and the Patient-Related
Wrist and Hand Evaluation
Australia. (PRWHE)

Most common treatments were


orthoses (92%), pain education
(78%), heat (75%) and exercise
therapy (74%)

97% thought pain was reduced by


an orthosis, 11% said they gave
everyone the same splint, and
53% said they asked their
patients to sleep with their splints
on for the first 2 weeks.
­99
­100

Source Design and participants Intervention Outcomes Results Quality and comment

Egan and Systematic review Splinting for CMCJ Depending on the study Clinical interpretations of the evidence Grade B – Moderate
Brousseau OA. concerned, the outcomes include that splint use appears to:
(2007) Aim: to review the evidence examined included: • Decrease pain for many Downgraded from A due to limitations:
regarding the effectiveness of • Subsequent need for participants • Risk of bias due to lack of
splinting for CMC OA surgery • Reduce subluxation on pinch in independent assessment of
• Level of pain participants with early OA, so they literature and its inclusion in the
Inclusion: experimental or • Compliance with splint should be encouraged to wear review (one reviewer only); a second
observational studies that examined wear splints during ADLs that cause assessor would have improved
the effects of splinting for OA of the • Restriction on activity subluxation validity
CMC joint in adults during splint use • Have no impact on decreasing the • Only brief description of each study
• Comparison of different eventual need for surgery • Variety of study designs, four with
Exclusion: splinting post-operatively, types of splint reasonable methodological quality
splinting used as an adjunct to • Reduction of CMC There were no specific indications for • No information about the limitations
medical treatments, e.g. subluxation splint type selection (e.g. short or long of these studies, although it was
corticosteroid injections • Pinch strength opponens design) so participants’ noted that the researchers’
• Participant preference. preference and functional needs are calculations for pain relief varied
Wide range of timescales applied key when discussing splint from those of the authors for one
from databases used (1962–2006) characteristics study

Seven studies were found to meet An initial period of continual 3–4 Comments:
Hand and wrist orthoses for adults with rheumatological conditions

the inclusion criteria weeks of splinting may be beneficial. • All relevant studies were included
Splinting can then be according to due to the small number likely to be
Used evidence tables to record level aggravating ADLs available in this topic area
of evidence, sample, treatment, • Comment was made on the design
dosage, outcome, effect size and The use of splints during activities of the studies concerned and none
threat to internal validity promoting CMC subluxation should was found to lead to strong
be encouraged for individuals with evidence. A recommendation was
Number of participants varied from Stage I and II OA made for a high-quality RCT.
10 to 114, but only one study with
above 37 Effectiveness of intervention for pain
relief, alongside its conservative
Male:female ratio not always stated, nature and low cost, would indicate
but majority or all women splint provision is warranted.

Mean age: varied from 53.8 to 67.2


years.
Source Design and participants Intervention Outcomes Results Quality and comment
Royal College of Occupational Therapists 2020

Giesen et al Qualitative Two types of splint: Open-ended questions Hand function difficulties were identified Grade D – Very Low
(2010) about perception of hand in 7 sub-concepts:
[Cross- Aim: identification of problems silver ring splint (SRS) and function problems (at • Difficulty initiating finger flexion Comments:
reference people had with hand function due Oval-8® commercially baseline) and reason for • Painful PIP joint hyperextension • Participant responses to
with Giesen to the deformity and the reasons prefabricated thermoplastic choosing splints (at 10 • Dislike of appearance questions were only
et al 2009] for selecting particular types of splint (PTS) weeks, when the • Functional difficulties associated with handwritten verbatim
splints participants had trialled poor pinch or tripod grip and not recorded on
Each splint was worn for 4 both splints) • Large grip audio tape for accuracy
Qualitative study carried out adjunct weeks, with a 2-week • Applying pressure with fingertips • No mention of
to a randomised cross-over trial washout. The International • Hand function requiring multiple grips saturation of data
comparing silver ring and Oval-8® Classification of (dexterity) • Only the main functional
finger splints Functioning, Disability difficulty for each
and Health (ICF) was Splint wear/adherence was similar for participant was
Multicentre study carried out in used to help analyse the both splints. Mean (SD) adherence rates: recorded, therefore
three rheumatology outpatient data into ‘meaning units’ SRS – 15.3 hours per week (7.4) some data were lost
clinics relating to hand function PTS – 15.4 hours per week (7.4) • Authors state
difficulties. recruitment process not
Consecutively selected and included Splint preference: no overall clear based on inclusion of
in a randomised cross-over trial preference. After wearing each splint for maximum variation of
4 weeks, 24 participants chose SRS and participants, so findings
Inclusion: RA; mobile swan neck 21 chose PTS, and 2 were unable to cannot be generalised
deformity manually correctable to choose between them to all people with RA
≥45° of PIPJ flexion of index and/or with swan neck
middle finger; stable disease Positive aspect categories: deformities
activity; no corticosteroid injection • Effect (on hand function or pain) • Assessors not
for previous 3 months; no planned • Ease of use independent, so
surgery; no treatment with swan • Appearance potential source of bias
neck splints in past • Comfort • Questions asked about
positive and negative
Exclusion: condition other than RA Negative aspect categories: experiences with either
or other severe finger deformities • Side effects splint. If these had been
interfering with hand function or • Sharp edges rephrased in relation to
use of finger splints • Sweating both splints, may have
• Pain in adjacent finger due to friction elicited more/different
50 participants • Paraesthesia of splinted fingertip responses.
Male:female ratio = 9:41 • Splint slipping off
Median age (SD) = 53.8 years (21.6) • Change of fit during wear
Mean disease duration (SD) = 13.7
years (11.5) The positive and negative aspects of the
SRS and PTS demonstrated no
Netherlands. distinguishable pattern.
­101
Source Design and participants Intervention Outcomes Results Quality and comment

Giesen Randomised cross-over trial Two types of splint: Measures collected at Dexterity: both splints improved Grade C – Low
et al (2009) baseline, after the first dexterity as reported by the SODA
­102

[Cross- Aim: to assess the effectiveness, silver ring splint (SRS) and splint period, after the scores, and dexterity-related pain was Comments:
reference participant satisfaction and Oval-8® commercially washout period, after the also decreased • Not controlled
with Giesen preferences of silver ring splint and prefabricated second splint wearing and • Cross-over design
et al 2010] prefabricated thermoplastic splints thermoplastic splint (PTS) at the 12-week follow-up PIPJ hyperextension: reduced only by • Not fully blinded,
period the silver ring splint therefore potential for
Multicentre study carried out in three Each splint was worn for 4 bias
rheumatology outpatient clinics weeks, with a 2-week Primary outcome: Hand function, grip and pinch • No power calculations
washout • Dexterity – the SODA strength: not significantly improved due to small numbers
Consecutively selected and included or compromised by either splint • Dropout rate not
in a randomised cross-over trial Regimen to wear as much Secondary outcomes: calculated into proposed
as possible and remove • Hand function – hand and At 12-week follow-up there were sample size
Inclusion: RA, mobile swan neck only for cleaning finger domain of Dutch similar clinical outcomes, with the • Satisfaction questionnaire
deformity manually correctable to Arthritis Improvement exception of a significantly higher not validated
≥45° of PIPJ flexion of index and/or Following the two splint- Measurement Scale 2 score in three items of satisfaction in • Sample included
middle finger; stable disease activity; wearing periods, the (AIMS2) and Michigan the SRS group participant with early
no corticosteroid injection for participants wore their Hand Outcomes swan neck deformity and
previous 3 months; no planned preferred splint and were Questionnaire (MHQ) 24 participants preferred the SRS, 21 excluded people with
surgery; no treatment with swan neck followed up after 12 • Passive PIPJ preferred the PTS, and 2 participants other hand deformities,
splints in past weeks. hyperextension – chose neither. Over 60% of which may not be a
goniometer participants indicated they would typical presentation in
Exclusion: condition other than RA or • Cylindrical grip and pinch continue to use the splints after the contemporary practice.
other severe finger deformities strength – Jamar® study
interfering with hand function, or use dynamometer
Hand and wrist orthoses for adults with rheumatological conditions

of finger splints • Satisfaction (measured at Cost of the splint provision is


all points except baseline) discussed and authors recommend
Fifty participants from 83 screened; • Splint preference (after therapists to consider the cheaper
47 (94%) of those completed the second splint worn and at PTS style (15 euros) over the more
study 12-week follow-up) expensive SRS (80 euros)

Male:female ratio = 9:41 Adherence recorded in diary There were a small number of
Median age (SD) = 53.8 years (21.6) for the two 4-week splint participants who reported adverse
Mean disease duration (SD) = 13.7 periods. effects of the splints, such as skin
years (11.5) problems

Netherlands. Effectiveness evident for both


improving dexterity and reducing
dexterity-related pain after 4 weeks
of splint use

Both types of splint were found to be


effective and acceptable for
treatment of mobile swan neck
deformity in people with RA.
Source Design and participants Intervention Outcomes Results Quality and comment

Gomes Randomised controlled trial Custom-made functional Measures at baseline, All participants completed trial Grade B – Moderate
Royal College of Occupational Therapists 2020

Carreira et thermoplastic splint for 45, 90 and 180 days with no loss to follow-up
al (2010) Aim: to assess the effectiveness of splinting for the trapeziometacarpal (measured while Downgraded from A due
trapeziometacarpal joint in Grades II and III OA stabilisation, made by an wearing splint and Pain: splinting effectively to limitations:
occupational therapist, for without) reduced pain in both groups, • Sample size appears
Inclusion: clinical and radiological diagnosis of all participants in both but IG showed improvement as small – 40 participants
idiopathic Grade II and III OA of the groups Primary outcome: early as 45 days, maintained at in total, 20 in each
trapeziometacarpal joint; dominant hand; over 40 • Pain – VAS (10 cm) 90 and 180 days. CG improved arm, although author
years of age; dominant hand thumb base pain Intervention group (IG): only after 90 days when these reports needed only a
between 3 and 7 on 0–10 cm visual analogue scale Splint used during ADL, Secondary outcomes: participants also started to use minimum of 17 per
(VAS) including work activities, • Functional capacity the splint for ADL group to demonstrate
for 180 days. Instructed to – DASH 2 cm improvement in
Exclusion: severe deformities of the dominant hand remove it for sleeping, • Grip strength – At 180 days the improvement in VAS for pain, and that
that prevented gripping between 1st, 2nd and 3rd bathing and ADL with Jamar® pain was significantly different numbers recruited
fingers; deformities of the distal interphalangeal joint contact with heat dynamometer between the IG and CG allow for possible loss
(DIPJ); use of thumb splint in previous 6 months; • Pinch strength – (p=0.003), demonstrating an to follow-up of 20%
allergy to the splint material; surgery on the hand Control group (CG): Splint pinch gauge additional gain from longer use (which didn’t
studied in the previous 6 months or scheduled in the used only during • Upper limb of the splint materialise)
upcoming 6 months; injections in the hand under evaluations for first 90 dexterity – • Only states that the
study in the previous 6 months; changes in use of days, then during ADL for O’Connor test (with Grip strength: no significant evaluations were
anti-inflammatory medication and analgesics in the second 90 days. and without splint). changes in power or pinch grip carried out by blinded
previous 3 months; incapacity to respond to the strength with use of splint. Key assessor; not clear if
questionnaire and perform the tests; geographical grip strength was reduced with the occupational
inaccessibility; other associated diseases, e.g. carpal splint wear in both IG and CG therapist was blind to
tunnel syndrome, fractures in the carpus, tendonitis, the treatment
chronic inflammatory arthropathy Function: improvement but not
statistically significant in DASH Comments:
40 participants from Rheumatology department scores • DASH may not have
randomised into intervention or control group been responsive
Manual dexterity: no statistically enough as a measure
Intervention group: significant differences found • Study population
Male:female ratio = 0:20 between groups. IG participants almost entirely female
Mean age (SD) = 62.8 years (8.5) completed the O’Connor test in – may limit
Mean disease duration (SD) = 6.3 years (3.4) a shorter time with the splint generalisability of
findings
Control group: Concluded that splint use • Information not
Male:female ratio = 2:18 during ADL for this group collected on splint
Mean age (SD) = 65.1 years (10.1) reduces pain, has minimal adherence, adverse
Mean disease duration (SD) = 7.7 (6.1) impact on functional capacity effects, participant
and does not alter grip experience and
Brazil. strength, pinch strength or opinions of splint
dexterity. wear.
­103
­104

Source Design and participants Intervention Outcomes Results Quality and comment

Gooberman- Participatory design Two interactive discussion fora, • Acceptability of splints • Use of placebo arm is acceptable Grade D – Very Low
Hill et al one in Bristol and one at Keele, • Wearability – defined • Findings will inform design of
(2013) Aim: to involve people who each of 3 hours’ duration by materials, warmth, subsequent Delphi exercise and Comments:
access services in the design colour, type of RCT • Will inform a Delphi exercise
and selection of a placebo Groups facilitated by research fastenings, appearance • Future trial will include and randomised controlled
splint to enhance a future staff, including two project • Support gained from investigation of acceptability of trial
clinical trial of splints for OA research fellows and two clinical thumb splints with/ placebo splint • Small number of participants
thumb research fellows (one an without immobilisation • Evaluation of existing splints • Limited recruitment sources
occupational therapist), and • Whether or not included views that: neoprene too • The two groups were very
Recruitment source: those designed to encourage placebo arm is an hot in summer, beige colour too different sizes and this affects
known to clinical occupational discussion and collaboration acceptable feature of medical and not practical, dislike dynamics – one forum
therapists; authors describe between participants and project future trial of hard plastic moulded splints, contained only two
them as research partners, staff • Input to potential hook and loop fastenings easy to participants
rather than participants design of placebo don/doff but catch on clothing, • Acknowledged that study did
Interactive discussion between splint. concerns re washing splints, not discuss results of
Bristol: 6 participants participants and research staff, stigma re wearing (makes previous RCT with the fora
Male:female ratio = 0:6 and the opportunity to try on a disability obvious). Support from members as they had already
range of splints splint was viewed as essential concluded that placebo
Keele: 2 participants • Recommended placebo splint would have a beneficial effect
Hand and wrist orthoses for adults with rheumatological conditions

Male:female ratio = 1:1 Topics covered in session: design: • Facilitators were not
• Experience of OA and of their • • Colour: beige independent, and this may
Age range: 56–72 years own thumb splints • • To incorporate elastic fabric and have influenced the
Disease duration: 9 months to • Exposure to a number of hard plastic element participants.
28 years alternative splints during the • • Hook and loop fastenings
session, which they tried on • • Must not offer ‘real’ support for
Inclusion criteria: thumb base and evaluated carpometacarpal (CMC) joint
OA, thumb splints already • Views of the acceptability of • Blinding: those wearing placebo
prescribed placebo arm in future trial splint/s should not mix with those
• Acceptable and unacceptable wearing active splint, e.g. at clinic.
Exclusion criteria: none stated design features for proposed
placebo splint, with focus on
United Kingdom. wearability and support.
Royal College of Occupational Therapists 2020

Source Design and participants Intervention Outcomes Results Quality and comment
Hamann et al Cohort study 4 orthoses were used: Range of motion of the All orthoses restricted motion in Grade D – Very Low
(2014) BSN medical, Push thumb CMC and all directions. CMC joint
Aim: to characterise the stabilisation, braces, Sporlastic and metacarpophalangeal (MCP) stabilisation was largest with MEDI Downgraded due to:
effectiveness and functionality of MEDI. while using the 4 orthoses and BSN medical, and lowest with • Need to replicate the
different thumb carpometacarpal (CMC) and without orthosis via Push braces. For the MCP joint, study to understand
osteoarthritis (OA) orthoses three repetitions of the largest restriction of motion if the splint can still
maximum opposition- was with MEDI followed by BSN provide functionality
Exclusion: prior thumb surgery or reposition medical, while Sporlastic and Push and stability, and
concomitant neurological diagnoses braces restrained very little could have
Hand function via the motion addressed areas
18 participants Sollerman test. around pain and
Male:female ratio = 0:18 Hand function was greatest with compliance
Mean age = 63 years old the Push braces (average
All had stage II/III CMC OA Sollerman test sum score of Comments:
Where both hands affected, most 78/80) and lowest with MEDI • Limitations included
symptomatic hand in terms of pain was (46/80) (significantly different to the possibility that
studied the other orthoses, p<0.05). The increased pain
BSN score was 72/80 and during range of
Germany. Sporlastic was 75/80. motion
measurements
influenced outcomes,
and all participants
were women
• Pain levels were not
tested, so unable to
conclude which
orthosis provided the
best pain relief with
minimum loss of
function.
­105
­106

Source Design and participants Intervention Outcomes Results Quality and comment
Hammond et Systematic review All studies were • Proximal interphalangeal Three studies were moderate Grade C – Low
al (2016) randomised controlled joint circumference quality and 1 study low quality
Aim: to review the evidence on the cross-over trials • Pain Downgraded due to:
effects of compression gloves on adults • Stiffness Significant reductions in • Dated studies and outcome
with rheumatoid arthritis (RA) and Nylon/elastane and • Swelling proximal interphalangeal joint measures with inconclusive
osteoarthritis (OA) thermal compression • Numbness circumference, though not findings
gloves were tested • Night throbbing accompanied by reduced
Inclusion: randomised controlled trials (though 3 of those used • Health status finger stiffness, improved Comments:
(RCTs), quasi-RCTs and randomised are no longer • Grip strength flexion or dexterity • Limitations include the poor
cross-over controlled trials published in manufactured) • Pinch strength reporting of baseline and
English using compression gloves to • Range of motion Inconclusive results for pain, follow-up data and the age
manage RA or hand OA that had been All wore gloves at night. • Dexterity stiffness, numbness, night of the studies
diagnosed by a physician. Gloves were • Hand volume throbbing and health status • Because of the age of the
provided by health professionals • Number of tender joints. studies, some outcome
No significant differences measures used are now
Hand and wrist orthoses for adults with rheumatological conditions

Exclusion: studies that evaluated 2 types between compression gloves infrequently employed.
of glove without a control group or and placebo gloves for grip
phase as a comparison, case studies, strength, pinch strength, range
observational studies or reported only in of motion, dexterity, hand
abstracts, poster presentations or volume or number of tender
conference proceedings joints

4 studies Women were more likely to


Published between 1970 and 1990 report positive attitudes to
Methodological quality assessed by glove wearing, with men
PEDro scale. reporting that the gloves were
too short or small.
Source Design and participants Intervention Outcomes Results Quality and comment

Haskett et Randomised controlled trial Total trial period 14 weeks Assessment at baseline, Splint wear – average 29 hours per week Grade B – Moderate
Royal College of Occupational Therapists 2020

al (2004) plus follow-up visit at 6 after each splint phase


Aim: to compare the effect of months and washout period, and Pain: all splints reduced pain (p=0.007) Downgraded from A due to
three types of wrist splint on at 6-month follow-up compared with baseline limitations:
perceived wrist pain, hand Three splint types: • True blinding not stated
function and perceived upper • Rolyan® wrist extensor Primary outcome: Custom LWS was more effective in reducing and biases may have
extremity function orthosis (RWS • Pain – VAS (10 cm) pain than the AWS, although differences affected outcomes
prefabricated) between LWS and RWS, and RWS and AWS,
Recruitment via referral to • Custom-made leather Secondary outcome: were not statistically significant. Compared Comments:
occupational therapy wrist splint (LWS) • Hand function – Arthritis with baseline, all three improved perceived • Small sample size
department in a specialised Wrist extension 15–20° Hand Function Test wrist pain; however, only the change with the • No confidence levels
arthritis treatment centre Ulnar deviation 5° (AHFT) – hand strength LWS was statistically significant (LWS p=0.001; presented
• Anatomical and dexterity RWS p=0.06; AWS p=0.38) • Large variation at baseline
45 participants randomly Technologies elastic • Perceptions of function on number of variables
assigned to treatment in wrist support (AWS – McMaster Toronto Hand function: regardless of splint type, grip • Not possible to blind
three-phase cross-over trial prefabricated) Arthritis Patient Function strength, 2-point pinch strength, 3-point pinch participants or practitioners
Preference strength, aggregate applied dexterity, and • Outcome assessors were
Inclusion: inflammatory Each of the splints worn questionnaire pouring water were significantly improved independent but unclear if
arthritis affecting wrist with for 4 weeks with over baseline (p<0.02). Pegboard dexterity and blind
any two other symptoms separation by 1-week Splint use – daily diary lifting were not improved with splint use • Practical significance of the
(palpable swelling, pain on washouts record grip improvements not
direct pressure, pain on A significantly stronger grip resulted with the measured
motion, wrist ROM restricted Splint to be worn during Costs considered: splint, RWS compared to the AWS (p=0.04); the LWS • Repeated measures used at
by ≥20%) and aged ≥20 years activities during the day fitting time and compromised pegboard dexterity marginally assessment at regular
that cause pain or participant’s instructions. more than the AWS (p=0.03). There were no intervals (smallest gap 1
Exclusion: previous splints; not discomfort; minimum of differences between the LWS and RWS on any week), therefore there may
willing to participate in a 10 hours per week of the AHFT items have been a practice effect
2-week washout period pre- • By the time the third splint
trial; required combination All splints were fitted by Preference: ranked LWS (most preferred), was applied there may
wrist splint (i.e. with thumb); an occupational therapist. RWS, AWS have been a degree of
post-operative; excessive functional adaptation that
subluxation; unstable Wrist splints reduced pain, improved strength could have influenced the
medication regimen and did not compromise dexterity after 4 results.
weeks’ use
Male:female ratio = 6:39
Mean age (SD) = 49.1 years Improvements maintained at 6 months and
(13.0) no harm was identified
Mean disease duration (SD) =
8.6 years (9.2) Costs (splint, fitting time and instructions):
RWS $58 Canadian dollars [CAD]
78% participants – RA LWS $100 CAD
AWS $30 CAD.
Canada.
­107
­108

Source Design and participants Intervention Outcomes Results Quality and comment
Healy et al (2018) Systematic review 43 RCTs examined use of Osteoarthritis: Osteoarthritis: Grade B – Moderate
orthoses for arthritis • Grip strength
Aim: to assess the effectiveness and treatment – 4 studied • Pinch strength Significant small effect size found Downgraded due to:
cost-effectiveness of prosthetic and orthoses for the hand for • Pain between orthoses and control • Limited studies and not
orthotic interventions osteoarthritis, 2 studied • Thumb opposition score group for thumb opposition specific to one disease or
orthoses for the hand (Kapandji index) score in 1 study condition
Inclusion: randomised controlled trials and wrist for rheumatoid • Thumb counter-opposition
(RCTs) published between 1995 and and juvenile idiopathic score (Kapandji index) Those who used thumb splint for Comments:
2015 that provided devices for a clinical arthritis and 2 for the • Cochin Hand Function 90 days had better pain • Limitation included
problem for use during activities of hand only Scale reduction than those who used it limiting analysis to
daily living (ADLs), involved all ages and • Closure of the first web for evaluation only in 1 study baseline versus final
any medical conditions, and used Osteoarthritis: 2 of these • Kallman score (effect size: −1.1 (95% CI −1.90 to assessment, potentially
validated outcome measures compared thumb • Disabilities of the Arm, −0.30)) missing significant
orthoses to a control Shoulder and Hand differences in between
Exclusion: involving healthy condition while 2 instruments (DASH) All other outcome measures • Not able to make a
participants, examining devices for compared thumb splint showed no significant differences strong conclusion on the
prevention of injuries and within interventions Rheumatoid and juvenile effectiveness or cost-
therapy/training sessions, examining idiopathic arthritis: Rheumatoid and juvenile effectiveness of orthoses
Hand and wrist orthoses for adults with rheumatological conditions

new/research devices, not published in Rheumatoid and juvenile • DASH idiopathic arthritis: • Most outcome measures
English idiopathic arthritis: 2 • Grip strength were self-reported and at
compared wrist splints to • Dexterity 1 study found significant pain risk of bias
323 RCTs control condition, 1 • Ulnar deviation reduction in the control group • It was not always
319 examined orthotic interventions compared hand splints to • Stiffness compared to a wrist splint (effect possible to blind
4 examined prosthetic interventions. a control group and 1 • Michigan Hand Outcomes size: 1.35 (95% CI 0.96 to 1.74)) participants due to the
compared 2 hand splint Questionnaire nature of the
interventions. • Pain 1 study found thumb orthosis intervention
• Pinch strength produced significant effect sizes • An extensive range of
• Stanford Health for pain, pinch strength and outcome measures was
Assessment Stanford Health Assessment used across studies.
Questionnaire. Questionnaire

No other outcome measures


showed significant differences.
Royal College of Occupational Therapists 2020

Source Design and participants Intervention Outcomes Results Quality and comment

Hermann Randomised controlled trial Intervention ‘orthosis’ group: Participants were assessed 55 participants completed the trial. Grade B – Moderate
et al prefabricated Thumb at baseline (before group
(2014) Aim: to explore the feasibility and Support 202 orthosis and allocation) and after 2 Pain: orthosis group reported Downgraded from A due to
assess the effect of a prefabricated hand exercises as per the months significantly less pain when wearing limitations:
soft thumb-based orthosis on pain, control group the orthosis for three measures: • Small numbers in each
hand strength and activity Primary outcome: Pain during R grip p=0.01 group and very small
performance in persons with OA of Regimen: wear splint as • Pain – Numeric Rating Pain during L grip p=0.02 proportion of men
the CMC joint much as wanted, especially Scale 0–10 (level of pain Pain during L pinch p=0.04 • Could not be double-
when symptomatic and following measures of grip A soft orthosis appears to have an blinded
Department of Rheumatology when performing heavy and pinch strength) immediate pain-relieving effect when • Retrospective questions
referrals manual tasks worn. There were no significant used for frequency/use of
Secondary outcomes: differences between the two groups in splint – likely recall bias
Inclusion: hand OA diagnosed by a Control group: • Grip and pinch strength the pain measures • A weakness in the
physician according to the American hand exercise programme – GrippitTM orthosis material was
College of Rheumatology, thumb of 4 hand exercises, 2 • Self-reported hand Pinch strength: trend towards increase discovered partway
pain on palpation, and ability to sessions per day with 10 symptoms and activity in strength through the trial: this was
communicate well in Norwegian repetitions of each exercise performance – Australian/ corrected in the
in the study period Canadian Osteoarthritis Grip strength: trend towards remaining two-thirds of
Exclusion: previous thumb surgery; Hand Index (AUSCAN) decreased grip in orthosis group when the orthosis group but
cortisone injection during the past 2 Medical treatment provided wearing orthosis (significantly for right may have influenced the
weeks before inclusion; other for all participants as usual Self-reported frequency of hand grip strength) support given and the
diseases that could have an impact during the study period, hand exercises: a 5-point frequency of use of the
on hand function; cognitive deficits including use of scale used by all participants There were no significant differences splint
symptomatic medication for at 2 months between the groups in the secondary • No consistency in
59 participants (from eligible sample hand OA. outcomes at follow-up wearing across the
of 116) randomised to intervention Self-reported splint wear: intervention group
‘orthosis’ group (30 participants) or 5-point scale Orthosis was reported most frequently • Synergetic effects may
control group (29 participants) as useful for rest/sleep, dressing, have been present with
Experience of wearing splint gardening, washing floors, vacuum the combination of hand
Male:female ratio = 1:58 – semi-structured interviews cleaning, driving and writing by hand exercises and orthoses in
Mean age (SD) = 70.5 years (6.7) conducted by an the orthosis group.
Disease duration (median, range) = occupational therapist. Satisfaction: 17 participants satisfied
15.2 years (5, 41) with the orthosis design; 11 reported
that they would like more support to
Norway. the CMC joint

23 would continue to use the orthosis


after the study, 3 would not, and 2
were uncertain because of difficulties
putting the orthosis on.
­109
­110

Source Design and participants Intervention Outcomes Results Quality and comment

Kjeken Randomised controlled trial Intervention – assistive Assessed at baseline (before AT group: 34/35 received assistive Grade A – High
et al technology, which allocation) and after 3 months technology devices, 26 received
(2011a) Aim: to evaluate the effect of assistive includes assistive splints Comments:
technology on OA of the hand devices and orthoses or Primary outcome: • Only two males in the
splints • Activity performance and Self-reported assistive technology population studied
Inclusion: adults with hand OA diagnosed satisfaction with performance usage: 92% in the AT group Comfort • Short-term follow-up
by a rheumatologist or orthopaedic surgeon Intervention group (AT): – COPM (Canadian with usage rated as high (only 3 months)
according to criteria of American College of received information Occupational Performance • Occupational therapist
Rheumatology; minimum of two self- and assistive devices Measure) Activity performance and carried out the
reported activity limitations secondary to and/or splints satisfaction: COPM scores identified evaluations and
hand OA; aged <80 years; and able to Secondary outcomes: significant positive change in participants were not
communicate in Norwegian Control group (CG): • Disease activity (modified performance (p=0.003) and ‘blind’ to treatment
received information health questionnaire) satisfaction scores (p>0.001) in the but observer was
Exclusion: hand surgery within the past 6 only • Pain, fatigue – VAS AT group at 3 months. High ‘blinded’
months or medication changes in the past • Function – AUSCAN hand confidence levels (95% CI) indicated • Some participants had
month; functional impairment due to Information consisted of index function score moderate to large treatment effect already had AT devices
trauma or other diseases; cognitive or details about hand OA • Clinical observations of the (effect size: 0.9) and splints at baseline
mental impairment. Participants who had and a leaflet containing hands by joint counts was • Possible harmful
hand surgery during the trial or changed three hand exercises carried out by the The control group had a significant effects of assistive
medication in the past month were and five suggestions for occupational therapist to negative effect on COPM technology not
excluded from the three-month follow-up alternative working determine severity performance scores (p=0.005) investigated.
Hand and wrist orthoses for adults with rheumatological conditions

evaluations methods to improve • Radiological OA of CMC joints


hand function and ADL Function: AUSCAN hand index
Consecutively recruited via outpatient clinic. performance. Compliance measured via function score showed significant
70 participants randomised to either questionnaire as well as improvement in AT group at 3
intervention group or control group including questions re comfort. months (p<0.001). Adjusted mean
difference between AT and control
Intervention (AT) group: group of −0.3 (p=0.06, effect size
Male:female ratio = 1:34 −0.5)
Mean age (SD) = 61.1 years (6.0)
Mean disease duration (SD) = 11.5 (8.3) The other secondary outcomes,
such as pain and fatigue,
Control group: demonstrated small and non-
Male:female ratio = 1:34 significant change.
Mean age (SD) = 59.9 years (7.5)
Mean disease duration (SD) = 10.0 years
(8.0)

Norway.
Royal College of Occupational Therapists 2020

Source Design and participants Intervention Outcomes Results Quality and comment

Kjeken et Systematic review Splint classified according to Main outcome 12 studies, 7 of which assessed the effectiveness of Grade A – High
al (2011b) location, primary anatomic parts measures: splints and 2 a combination of splints and exercises in
Aim: to describe and included, direction and purpose, • Pain people with hand OA. Three considered exercise Comments:
evaluate the design and number of joints included and • Need for surgery alone • Despite searching for
effects of splints and material used (rigid, semi-rigid, • Pinch strength good-quality literature,
exercise programmes in soft) • Function Broad variety of designs for both splints and exercise mostly papers with a
hand OA programmes high risk of bias were
Design and effects of both Dexterity and splint sourced
Search included splinting and hand exercises, satisfaction also Meta-analysis of effect of splints demonstrated that • Variation in materials
randomised controlled separately and together: looked at in a small splints significantly reduce hand pain. All splints used in splint design
trials, controlled clinical • Design of splints number of papers. designed to support thumb joint • Did not state a
trials, controlled before • Effects of splints number of
and after studies, • Design of exercise Splint use effects: demographic
interrupted time series. programmes 2 RCTs had low risk of bias – showed that splints have characteristics, e.g.
Mixed population papers • Effects of exercise a significant effect on decreasing pain at short-term male:female ratio,
were excluded (1994–2010) programmes (<3 months) and long-term (≥3 months) follow-up; setting and countries
some uncertainty about heterogeneous effects for of studies, therefore
Inclusion: hand OA 12 trials: short-term follow-up and confidence interval was may be difficult to
• Randomised control trials = 5 large for long-term follow-up generalise results.
Exclusion: pharmacological • Controlled clinical trials = 5
and surgical intervention • Controlled before and after A long and rigid splint well tolerated at night gave
studies = 2. pain relief; shorter splint significantly reduced pain
311 participants overall during ADL
Men and women in studies
not detailed consistently, 7 high-risk papers: no significant effects of the splint
but appears there were in one paper; another showed soft splints to be more
more women, which is comfortable and conducive to function
consistent with other
literature and the disease CMCJ subluxation can be corrected by splinting in
incidence early stage OA, especially rigid splints

English, German, French Splints are prescribed for function and pain relief with
and Scandinavian language no consensus on when it is most useful to wear them
papers only.
Single trials:
• Hand exercises may reduce pain and increase
range of movement and strength, but evidence is
limited
• Splints and daily exercises combined may reduce
pain and stiffness and improve function.
­111
­112

Source Design and participants Intervention Outcomes Results Quality and comment

Maddali- Cohort study TMC joint OA butterfly Measures evaluated at Pain: significantly reduced at 30 days post- Grade C – Low
Bongi et al thermoplastic short baseline, first month (end intervention in both manual workers
(2014) Aim: to evaluate the usefulness of opponens custom- of treatment period) and (p=0.0001) and non-manual workers Comments:
a custom-made splint and made splint 12 months (p<0.0001), and combined results showed • Elements of the results do fit
educational programme for significant improvement in pain at 30 days with other studies on TMC
symptomatic trapeziometacarpal Worn 16 hours a day Primary outcome (p<0.0001) joint splinting in OA
(TMC) joint OA for 30 days and then • Pain – Numeric Rating • Bias towards the positive
when required up to Scale 0–10 12-month follow-up – this reduction in effects of the intervention –
Outpatient setting 12 months (non-standardised) pain was maintained: total scores i.e. does not report the results
evaluated at all three (p<0.0001), manual workers (p=0.0001) of all outcomes at 12 months
Inclusion: symptomatic TMC joint Plus an educational points and non-manual workers (p<0.0001) (only reported pain results)
OA in Stages I–III confirmed by programme of two • No control, and there could
hand X-ray 2-hour sessions. Secondary outcomes (at Grip and pinch strength – at 30 days the be significant bias with the
baseline and 1 month): whole group had improved significantly outcomes (analysis of bilateral
Exclusion: previous surgery or • Hand strength – Jamar® (p<0.0001) participant data) and fact that
infiltrative treatment of TMC joint; dynamometer the assessor was not blinded
inflammatory arthritis; • Pinch strength – pinch Manual and non-manual workers had • Combines splinting with
neuropathies and De Quervain’s gauge significant improvements in grip strength education, yet does not
tenosynovitis • Hand disability – Dreiser (both p<0.0001) and in pinch strength extrapolate the effects of
Hand and wrist orthoses for adults with rheumatological conditions

test (questionnaire) (p<0.001 and p<0.05 respectively) these on each other


Participants: 50 (12 bilateral OA • Some data analysis
TMC joints) Compliance: participant Hand function (Dreiser): at 30 days whole information gaps
diary group had improved significantly • Results not solely attributable
Male:female ratio = 6:44 (p<0.0001) (manual workers, p<0.05), but to splinting
Mean age (SD) = 60.72 years Safety: adverse effects no significant difference in the non- • No power calculations for
(10.63) leading to dropouts manual workers numbers needed to treat.

Manual workers: Satisfaction: single Adherence/compliance with splint wear


Male:female ratio = 1:26 question rated on scale of hours reported as high and no dropouts
0–10. or adverse effects reported. Splints were
Non-manual workers: not reported as needing any modification
Male:female ratio = 5:18 over study time.

Italy.
Royal College of Occupational Therapists 2020

Source Design and participants Intervention Outcomes Results Quality and comment

McKee and Case studies Provision of an orthosis as Self-reported narrative An orthosis must fit into a person’s Grade D – Very Low
Rivard (2004) part of an occupation- accounts of usefulness lifestyle. Six essential
Aim: to demonstrate and discuss focused occupational considerations: Comments:
application of a client-centred, therapy intervention Client satisfaction and • Client-centredness • Case study presentation
occupation-based practice framework programme performance measured • Comfort • Three client stories – no
for orthotic intervention by use of Canadian • Cosmesis information as to how
Both orthoses were Occupational • Convenience the selection was made
All female (3 case studies) individually made by the Performance Measure • Less is more (minimalistic design, • Only two of the three
occupational therapist (COPM). number of restricted joints, examples were for hand
Mildred – 75 years, OA IPJ dominant thickness, complexity of straps, orthoses
thumb, pain affecting activities Mildred: ulnar-based thumb ease of maintenance, visibility, • Narrative accounts.
interphalangeal orthosis, amount of skin enclosed)
Lynn – 26 years, spina bifida, foot thermoplastic, Plastazote® • Follow-up
orthosis lining, Velcro® straps and
modified glove Splinting can improve pain, but
Carol – 60 years, bilateral OA thumb author suggests that, as well as
CMCJ Carol: CMC thumb orthosis. efficacy of splinting, a client-centred
approach is important
Use of Canadian Model of
Occupational Performance for Report supported the use of the
intervention planning and the COPM for intervention planning and
associated outcome measure outcome measurement and
encourages use of this tool.
Canada.
­113
­114

Source Design and participants Intervention Outcomes Results Quality and comment

Moe et al Systematic review Non-pharmacological Outcomes: 173 reviews on hand OA identified. After eligibility Grade A – High
(2009) and non-surgical • Pain and quality screening, four systematic reviews were
Aim: to summarise currently interventions. • Stiffness included in this study. Splinting included in three out Comments:
available evidence on the • Function – as defined of four reviews • Paucity of high-quality
effectiveness of non- by International systematic reviews/
pharmacological and non-surgical Classification of 1. Splinting (3 × RCTs) and pressure gloves versus no evidence found
interventions for hand OA Functioning, Disability gloves (1 × RCT): intervention, control/duration • Methodological/
and Health (ICF) and outcomes not reported reporting issues or
Sources: Cochrane library, • Desire for surgery. 2. Splint design: conflicting results between two conflict between some
MEDLINE, EMBASE, PEDro, systematic reviews re effect size and direction in of systematic reviews
PsycINFO and CINAHL from 2000 relation to splint design, one concluding more studied
to week 40 of 2008 pain relief from full compared with half splint, • Search targeted hand
and the other reporting no clear evidence of one OA – may have missed
Hand-searching of reference lists type of splint being superior to another for pain some titles specific to
undertaken relief, comfort or function. Studies comparing thumb or fingers
different designs of thumb splint, different • May have missed some
‘Hand osteoarthritis/arthrosis or materials, and custom-made versus prefabricated, relevant studies –
OA’ marred by small sample sizes and unclear/ limited
conflicting effect sizes. Authors report it is • Languages included in
Inclusion: hand OA; high-quality reasonable to conclude that there is limited search, no conference
Hand and wrist orthoses for adults with rheumatological conditions

systematic reviews; non- evidence that splints can relieve CMC joint pain in proceedings or expert
pharmacological/non-surgical people with OA, but not enough evidence to give opinion accessed
interventions recommendations regarding design or materials • Absence of participant
3. Splint versus no treatment (1 RCT): study experience/opinion.
Exclusion: gene therapy; all types suggested that evidence was ‘fair’ for the
of invasive interventions; effectiveness of splinting to relieve pain and
therapeutic apheresis; improve function
pharmacology; surgery. 4. Desire for surgery (1 RCT, splint versus no
treatment): approximately 1/3 of each group
desired surgery; study authors’ conclusion is that
splinting did not affect this outcome

Suggests limited evidence that splinting of the


thumb CMC joint reduces pain.
Royal College of Occupational Therapists 2020

Source Design and participants Intervention Outcome Results Quality and comment
Nasir et al Literature review 5 clinical cross-over trials, 2 • Grip strength 3 studies rated on the PEDro scale as low Grade C – Low
(2014) clinical trials and 1 case • Pinch strength or moderate quality
Aim: to review effects of therapy study. • Range of motion Downgraded due to:
gloves use on adults with • Dexterity Grip strength improved in all studies, but in • Dated studies
rheumatoid arthritis (RA) • Hand pain only 2 significantly so
• Finger swelling Comments:
Inclusion: participants were 18 • Joint stiffness. Pinch strength was only measured in 1 • Limitations include the
years and older with RA and study and no effect was found use of outdated outcome
glove or glove-splint was used as measurement tools in
a therapy treatment and included Range of motion measured in 4 studies: 1 some studies, lack of
at least one of the following study found a significant improvement methodological quality
outcome measures: grip strength, (p<0.05), 1 study found self-reported rating, no correlation
pinch strength, range of motion, improvement, and 2 studies reported no between pain and
dexterity, hand pain, finger significant improvement stiffness relief, and
swelling or joint stiffness diminished swelling of
Dexterity was measured by 3 studies and the proximal
Exclusion: studies not published all 3 found improvement, though only 1 interphalangeal joints
in English significantly so (p<0.05) • Unclear how compression
gloves improve outcomes
8 studies Finger swelling was measured by 7 studies, (i.e. the mechanics of
4 published in the 1970s, 1 in with 6 reporting significant improvement, how they work).
1986, 2 in the 1990s and 1 in and 1 finding no significant improvement
2001.
Pain was measured by 7 studies, with 4
finding significant improvement and 2
finding improvement with no statistical
indicators, and 1 found no improvement

Joint stiffness was measured by 7 studies:


6 saw self-reported improvement, 1
significantly so, and 1 study saw no
improvement.
­115
Source Design and participants Intervention Outcomes Results Quality and comment
­116

Pagnotta Cohort study Prefabricated wrist • Pain: VAS (10 cm) measured Pain: with the splint on, pain was Grade C – Low
et al splint before and after the significantly lower in 5 tasks, i.e. 3 work
(2005) Aim: to identify the influence of Wrist extension 10–15° performance of each task, performance tasks (placing/turning key or Comments:
wearing a wrist splint on pain, work both with splint on and with knob/driving) and 2 endurance tasks • Small sample size
performance, endurance, perceived Using a work simulator, splint off (chopping with knife/placing) • Participants were
task difficulty and perceived splint participants performed allowed to practise the
benefit during the performance of 14 tasks, 10 assessing • Work performance and Perceived difficulty in task performance: task prior to testing
upper limb tasks work performance and endurance: Baltimore difficulty less for 13 of 14 tasks when situation
4 assessing endurance Therapeutic Equipment wearing splint (5 significantly) • Subjective judgement
A consecutive sample of individuals with splint on and off Company work simulator – of cut-off (20%) and
admitted for inpatient or outpatient computerised readouts Work performance: did not differ classification of VAS
treatment in a Rheumatic Disease Used the Baltimore were generated for each significantly with the splint on versus off score ≥7 as strong
Unit Therapeutic Equipment task perceived benefit
Company work Endurance: mean scores were always • Homogeneity within
Inclusion: diagnosis of RA, recently simulator. • Perceived difficulty: VAS (10 better with the splint on; differences participants
used a prefabricated and cm) reached significance on only one task • Use of a work
commercially available circumferential (pull electric cord) simulator for the tasks
fabric-type wrist working splint with a • Perceived splint benefit: VAS may not allow for
palmar metal insert (10 cm) Results revealed that for most tasks, adaptations the
there was generally a positive effect of participants already
Exclusion: unable to wear a • Splint wearing: splint use on hand function; however, make to tasks
prefabricated elasticised wrist splint questionnaire indicating a perceived splint benefit was marginal. The • No apparent follow-up
because of advanced wrist and hand list of common reasons for task with greatest overall perceived splint • Some participants
deformities; rash; allergies; altered wearing or not wearing benefit was ‘chopping with a knife’ could not complete the
Hand and wrist orthoses for adults with rheumatological conditions

sensation; skin breakdown; received splint. Each participant was task due to fatigue or
an injection of corticosteroid asked to indicate their Splint use: pain, and so 5 work
medication in the wrist or any small reasons for wearing the • Improved or did not change pain levels performance tasks and
joints of the hand or flexor tendon splint and to rank the two • Did not interfere with work 2 endurance tasks had
sheath of the hand within the most important reasons performance less than a full sample
preceding 2 months; diagnosed as • Increased or maintained endurance of participants.
having carpal tunnel syndrome • Disease activity: 4-point • Did not increase perceived task
associated with persistent numbness; rating scale difficulty for most tasks
severe finger deformities limiting grip
of the tools; clinical fusion of the • Tenderness: 4-point scale Subjective reports: in daily use the splint
radiocarpal joint; wrist and/or hand often ‘got in the way’ or made movement
surgery in the past 6 months • Crepitus: present or absent ‘cumbersome’. The majority reported not
wearing the splint regularly during daily
Male:female ratio = 4:26 • ROM: Treuhaft hand activities
Mean age (SD) = 56.7 years (14.2) assessment.
Mean disease duration (SD) = 9.2 The primary reason for those who
years (8.73) ‘sometimes’ or ‘often’ wore a splint was
pain management, but the majority did
Canada. not use their splints regularly.
Royal College of Occupational Therapists 2020

Source Design and participants Intervention Outcomes Results Quality and comment

Ramsey et Mixed methods systematic review, registered Working wrist splints Effectiveness defined via most Strong quantitative Grade A – High
al (2014) with the Centre for Reviews and frequently occurring outcomes: evidence, (including 9
Dissemination (CRD42012001946) Reports 23 studies, • function RCTs) (using Cohen’s d Comments:
comprising: • strength effect, d=0.7–0.8), backed • Wide variation of
Aim: evaluate effectiveness of working wrist • 9 randomised • pain up by qualitative literature definitions of ‘function’
splints in adults with RA controlled trials • dexterity that working wrist splints across the literature
• 4 experimental reduce pain makes comparison
10 databases searched from inception to • 3 observational Other outcomes were included in the difficult
September 2012 for quantitative and • 5 survey/ study but not presented in this paper: Moderate evidence that • Diversity of outcome
qualitative studies of the effectiveness of questionnaire swelling, deformity, ROM and quality of grip strength is improved measures – and use of
working wrist splints, plus hand-searching of • 2 qualitative studies life (d=0.3–0.4) but dexterity is standardised and non-
article references and relevant print and impaired standardised outcomes
electronic journals Meta-analysis could Analysis of the data: – made comparisons
not be carried out due Narrative approach to synthesis of the Insufficient evidence for more difficult
Inclusion: qualitative and quantitative studies; to heterogeneity of data was taken as opposed to a meta- the effect on function • Uses informal methods
effectiveness of working wrist splints in studies analysis, due to too many differences to detect publication
people with RA or the experiences and/or in the studies regarding settings, Working wrist splints bias within results
perceptions of people who access services Used the Preferred interventions and outcomes used reduce pain in people • Caution needed
and/or therapists or carers involved in the Reporting Items for with RA, produce regarding over-
provision of working wrist splints to people Systematic Review and Where possible the strength of the moderate improvement in interpretation of the
with diagnosed RA; English language only Meta-Analyses effect of change between groups was grip strength, and can results due to use of a
(PRISMA) guidelines, reported using Cohen’s d effect, with negatively affect dexterity narrative analysis
Exclusion: where <50% participants had RA; across 10 databases. d=0.2 small effect size, d=0.5 medium • Includes cross-over
including children with juvenile RA; where effect and d=0.8 large effect There is insufficient studies which author
splinting was included as part of an extensive evidence of the functional states may lead to
occupational therapy treatment programme; Meta-ethnographical approach taken wrist splint effect on inconclusive/biased
splints used post-operatively; studies to analysing the qualitative data function. results because these
addressing splints for the finger, thumb or compare effects within
pressure gloves (not wrist splints); conference Both approaches then combined in subjects rather than
proceedings order to compare and contrast the between groups.
interventions from the quantitative
Participants = 1,492 adults with diagnosed RA evidence with the qualitative data.
Mean age (from 16/23 studies) = 55.5 years
Male:female ratio – not stated in all studies
Mean disease duration (from 12/23 studies) =
9.3 years

Countries of study: not stated.


­117
Source Design and participants Intervention Outcomes Results Quality and comment
­118

Rannou Randomised controlled trial Intervention group: Primary outcome: Pain: no differences between Grade A – High
et al (2009) custom-made neoprene • Pain – VAS (0–100 mm) – groups at 1 month. Both groups
Aim: to assess the efficacy of splint to be worn at change from baseline to 1 improved from baseline but the Comments:
splinting for thumb base OA at 1 night. Covered the base month differences were not statistically • Risk of bias associated with
month and the efficacy, safety and of the thumb and thenar significant lack of blinding, especially
effects on disability at 12 months eminence but not the Clinical variables: participants and assessing
Parallel group multicentred – two wrist • Hand disability – Cochin Reduction in pain was greater in therapists
tertiary care hospitals Hand Function Scale – the intervention group than control • Trial was conducted in a
Splints made by change at 1 month at 12 months (p=0.002), as was specialist centre using
Inclusion: pain >30 mm on VAS; occupational therapists • Perceived disability scores reduction in disability by Cochin custom-made splints by
45–75 years of age; radiologic and adjustments could • Perceived global assessment Hand Function Scale score specialist occupational
evidence of OA; and either CMC be made as required • Pinch strength and pain (p=0.008) and participant-perceived therapists, so results may
enlargement or closure of 1st web during pinch – electric disability (p=0.003) not be generalisable to
space Control group: usual dynamometer other settings
care. • Range of motion 54% of the intervention group and • Cochin Hand Function Scale
Exclusion: post-traumatic arthritis; • Thumb mobility – Kapandji 11% of the control group reported may lack sensitivity
gout; inflammatory arthritis; index thumb opposition and that they had improved (p=0.001) • Neoprene splint looks like
neurological condition affecting the counter-opposition subscales at 12 months X-LITE® splint in the
upper limb; hand/wrist trauma in • Adherence and tolerance illustration.
the past 2 months; previous hand There were no differences between
surgery; collagen diseases; skin Change in pain level and groups in radiographic progression
conditions affecting splint wear; measures of disability at 12 or adduction deformity
steroid injection (referred to as months
Hand and wrist orthoses for adults with rheumatological conditions

infiltration) within 2 months; The results show that a rigid splint


previous splinting; psychiatric Co-interventions were also used at night did not influence
disorder; inability to speak or write assessed and radiographic pain levels in the first month of
French; pregnancy evidence of base of thumb OA use, but there was improvement in
as possible influencing pain and function at 12 months
112 participants randomised to variables.
intervention group (57 participants) Treatment adherence in
or control group (55 participants) intervention group was high: 93%
reported wearing splints 5–7 nights
Intervention group: a week at 1 month, 81% at 6
Male:female ratio = 4:53 months, 86% at 12 months and
Mean age (SD) = 63.0 (7.9) 75% during the whole year of
follow-up
Control group:
Male:female ratio = 7:48 90% satisfied with splint at 12
Mean age (SD) = 63.5 (7.6) months

France. No adverse effects directly


attributed to the splint were
reported.
Royal College of Occupational Therapists 2020

Source Design and participants Intervention Outcomes Results Quality and comment
Shankland et al Pre-post design First clinic visit collected Upper extremity activity 19 had right hands treated, 15 Grade C – Low
(2017) demographics, history of and participation via the had left hands treated and 26
Aim: to study the effects of a condition, home and work Disabilities of the Arm, had both hands treated Comments:
multimodal treatment on activity, environment, occupational Shoulder and Hand (DASH) • Limitations included
participation, impairment and performance issues, upper questionnaire (primary 58 did exercises once a day, 1 grade of OA unknown,
satisfaction of people with thumb extremity activity and outcome measure) twice a day and 1 three times a potential bias in
carpometacarpal (CMC) joint participation, and baseline day adherence data because
osteoarthritis (OA) physical measurements Occupational performance relied on self-reporting,
issues via the Canadian Mean hours per day of orthotic no control group, no
Recruitment: via letter sent to Intervention consisted of Occupational Performance use was 9.3 measurement of tripod
rheumatologists, plastic surgeons education about joint Measure (COPM) pinch and grip strength,
and occupational therapists who protection, assistive devices, All outcome measures showed assessments carried out
treat those with thumb CMC OA in fabrication of an orthosis, and Pain via the visual significant changes by one of the authors,
greater Montreal and instruction on a standard set analogue scale (VAS) confounding variables
announcement on the Canadian of exercises to facilitate joint DASH decreased by 9.3 may have influenced the
Arthritis Society website stability and pinch strength Thumb total active range (p<0.0001) results (e.g. medication),
(frequency and intensity of motion (TAROM), flexion and as it is a multimodal
Inclusion: OA of the CMC thumb individualised). The therapist and extension via a finger COPM performance scale intervention it is difficult
joint diagnosed by a physician and and participant jointly agreed goniometer increased by 2.5 points to say definitively what
ability to communicate in English or which orthotic design, wearing (p<0.0001) caused findings.
French schedule and materials best fit Lateral pinch strength via a
with the participant’s calibrated B&L Engineering COPM Satisfaction Scale
Exclusion: receipt of concurrent occupational needs. Pinch Gauge®. increased by 2.8 points
rehabilitation for thumb CMC OA, Participants asked to record (p<0.0001)
history of thumb CMC joint surgery, the length of time per day they
or presence of another wore the orthosis Pain improved by 1.9 cm
inflammatory disease (p=0.0001)
Visit at 3 weeks to encourage
60 participants adherence and discuss TAROM (left hand) increased
Male:female ratio = 1:14 problems 8.4 degrees (p=0.0001)
Mean age = 63.2 years
Visit at 6 weeks collected data TAROM (right hand) increased
Canada. logs and outcome data. 7.9 degrees (p=0.003)

Lateral pinch strength


increased 1.5lbs (p=0.001).
­119
­120

Source Design and participants Intervention Outcomes Results Quality and comment

Sillem et al Multicentre cross-over equivalence Two thumb splints: Data collection at baseline, Hand function (AUSCAN): Grade B – Moderate
(2011) trial at week 4, after the improvement in both groups at
Neoprene Comfort Cool® washout week and after 4 weeks but the hybrid splint Downgraded from A due to
Aim: to determine if two splints had prefabricated (fit use of second splint showed statistically significant limitations:
an equivalent effect on self-reported according to size) improvement over baseline • Therapists not blinded and
hand function, pain and hand Primary outcome: (p=0.02). No significant acted as assessors, also
strength after 4 weeks of use Custom-made • Hand function – difference between splints therefore risk of bias if therapist
thermoplastic hybrid splint AUSCAN functional has strong opinions/preferences
Hypothesis: both splints will have a fabricated from neoprene subscale Pain: improvement in pain for • Short follow-up
similar effect on function, pain and and 1.6 mm Rolyan® both groups at 4 weeks, but • 30/56 reported using analgesics,
strength in those with OA of the Aquaplast Watercolors Secondary outcomes: hybrid splint produced which may have increased the
CMCJ • Pain – AUSCAN pain statistically significant effects of splints
The two 4-week treatment subscale improvement (p<0.001) • Therapists were not blinded to
Recruited from three outpatient hand periods were separated by • Grip – Jamar® the outcome measures as they
therapy departments a 1-week washout period dynamometer Grip and pinch strength: very measured grip and pinch
• Lateral pinch – small improvement in both strength
Inclusion: clinical diagnosis of OA, i.e. Instructed to wear splints PrestonTM pinch gauge groups but not at a level of • Cross-over designs can have
not confirmed on X-ray; age over 45 when symptomatic, during significance after wearing limitations, i.e. exposure to
years; able to communicate in English heavier manual tasks and Satisfaction: with splint’s splints for 4 weeks other interventions
at night-time if desired comfort, appearance, • Severity of OA not assessed.
Exclusion: previous thumb surgery, convenience and durability Follow-up at 3 months did not
Hand and wrist orthoses for adults with rheumatological conditions

neurological diagnosis or OA Total duration of the study on a 5-point Likert scale show a significant difference
extending into wrist was 9 weeks plus a follow- between measures at 4 weeks
up phone call 3 months Daily log of hours worn. and 3 months for AUSCAN pain
Random assignment of 56 after initial baseline and function scores. Statistically
participants assessment. significant difference between
baseline and 3-month follow-up
Male:female ratio = 5:51 for both splints
Mean age (SD) = 64 years (8.61)
Mean disease duration (SD) = 2.99 Results showed equivalent
years (4.68) therapeutic effect on function,
grip and lateral pinch
Canada.
Pain relief was better in the
custom-made hybrid splint
group

Participants preferred the


Comfort Cool® splint.
Source Design and participants Intervention Outcomes Results Quality and
comment
Royal College of Occupational Therapists 2020

Silva et al Randomised controlled trial Night-time positioning Assessments undertaken at Total of 47 participants included at Grade A – High
(2008) splint, custom-made baseline, 45 days and 90 final assessment
Aim: to evaluate the effectiveness of a night- from thermoplast and days Comments:
time positioning hand splint in people with RA in fixed with hook and Pain: decrease observed in the more • Control group
terms of pain, grip and pinch strength, upper loop straps Primary outcome: affected hand in the intervention received no
limb function and participant satisfaction • Pain – VAS (0–10 cm) group, while pain remained constant intervention
More affected hand in the control group. A significant • Follow-up for 3
Participants recruited sequentially from Wrist dorsiflexion 10° Secondary outcomes: difference was detected between months only, so
rheumatology outpatient clinics MCPJ flexion 25–30° • Functional status – Health groups over time (p<0.001) long-term effects
PIPJ flexion 30° and Assessment Questionnaire not studied
Inclusion: 18 to 65 years with RA as classified thumb abduction (HAQ) in interview form HAQ scores: decreased in the • 1 participant at end
according to American College of Rheumatology • Upper limb disability and intervention group but remained of 3 months
(ACR); use of the same DMARDs for at least 6 Intervention group: symptoms – Disabilities of constant in the control group. A admitted did not
months prior to intervention; same doses of night-positioning splint the Arm, Shoulder and significant difference between use splint correctly
corticosteroids and NSAIDs for at least 1 month prescribed for use Hand (DASH) groups was shown over time • No analysis for
prior to the study; a score of >3 and <7 on a while sleeping administered in interview (p<0.005) participant
visual analogue scale for pain in the more form (modules for work satisfaction
affected hand Control group: the and general upper limb DASH (work): decrease in scores in outcomes
splint was used only symptoms) the intervention group and constant • Duration of RA, 9–10
Exclusion: deformities that prevented fabrication during evaluation. • Pinch strength – pinch scores in the control group. A years
of the splint; use of any other upper limb splint; gauge significant difference was detected • Functional outcome
surgery scheduled within 6 months following the • Grip strength – Jamar® (p=0.011) measure used only
study; allergies to the splint material; living in dynamometer mean of two of the three
inaccessible areas with difficult access to three measurements was DASH (upper limb symptoms): DASH modules.
transportation used for analysis intervention group showed
• Participant satisfaction – improvement in scores after 45
50 participants with RA were randomly divided Likert scale consisting of 5 days; control group scores were
into 2 groups (25 in each group) answers (much worse, constant. A significant difference
worse, same, better and was detected over time (p<0.010)
Intervention group: much better)
Male:female ratio = 5:20 • Diary to record hours of Grip strength: intervention group
Mean age (SD) = 51.64 years (11.4) use of splint. increased strength, while control
Mean disease duration (SD) = 10.12 years (7.39) group decreased. Over the 3
months, the difference between the
Control group: groups was significant (p=0.04)
Male:female ratio = 4:21
Mean age (SD) 50.72 years (10.51) Pinch (key, palmar and tip): showed
Mean disease duration (SD) = 9.02 years (6.8) significant improvement in the
intervention group in intra-group
Brazil. analysis compared to the control
group

Mean use of splint: 8 hours per


­121

night (SD 1.57).


­122

Source Design and participants Intervention Outcomes Results Quality and comment
Spaans et Systematic review • Hand therapy Pain. 9 RCTs looked at orthoses Grade B – Moderate
al (2015) • Intra-articular
Aim: to review injections with 2 found that orthoses, compared to no orthoses, Downgraded due to:
randomised controlled hyaluronate or reduced pain but did not impact functional capacity, • Risk of imprecise findings
trials (RCTs) on steroid, various grip or pinch strength with lack of statistical
conservative treatment of orthoses, analysis, small sample sizes
thumb base osteoarthritis transdermal 6 RCTs compared various orthoses with no justification and no
(OA) steroid delivery • 2 studies found that both prefabricated and custom- demographic information
and leech made orthoses reduced pain, but custom-made did included, making
Inclusion: published in therapy. so significantly more generalising difficult
English, conducting an • 1 RCT compared short and long prefabricated
RCT to trial conservative opponens orthoses and compared a long, Comments:
treatments for thumb prefabricated orthosis and a short custom-made one. • Orthoses studies were
base OA or reviewing/ They found significant pain reduction in all groups heterogeneous in nature,
meta-analysis of RCTs • 1 RCT found no significant pain reduction differences making comparisons
between 3 orthoses difficult
23 studies, not all of • 1 RCT compared a thumb strap orthosis and • No evidence that a custom-
Hand and wrist orthoses for adults with rheumatological conditions

which looked at orthoses. abduction exercises on one hand to a short opponens made orthosis is superior to
orthosis and pinch exercises in the other hand. Both a prefabricated orthosis,
showed reduced pain and increased strength and that a certain length is
hand function, but no significant differences between superior, or that constant
the two groups use is more effective.
• 1 RCT compared an orthosis with hand exercises with
hand exercises only. Concluded orthosis provided
pain relief only when worn

1 RCT compared the supply of technical accessories,


technical accessories and a semi-stable orthosis, and
technical accessories and a non-stabilising orthosis in
people waiting joint replacement arthroplasty. These
prevented over 70% of patients from requiring surgery.
Royal College of Occupational Therapists 2020

Source Design and participants Intervention Outcomes Results Quality and comment

Spicka et al Pilot observational study Silver ring splints – Measures taken with 40 eligible participants invited Grade D – Very Low
(2009) custom-made by and without the SRS to join study. 8/40 (20%)
Aim: to assess the impact of proximal jeweller worn: consented and participated Downgraded from C due to:
interphalangeal joint (PIPJ) silver ring • Small effect
splints (SRS) on measurements of hand Highly localised splints 1. Hand dexterity, The difference in dexterity and • Findings not statistically significant
dexterity and grip strength in individuals that are not widely measured by the grip strength was not • Missing baseline data
who were already routinely wearing available on the NHS. Nine Hole Peg Test statistically significant (p>0.05), • Only 8 participants (32 non-
these splints (NHPT) for either hand, either when responders out of those deemed
2. Grip strength, the SRS was worn or not worn eligible and invited to join study)
Recruitment via Occupational Therapy measured by the • Authors’ acknowledgement of the
Department and Rheumatology Clinic MIE digital grip A trend was apparent towards possibility of Type II error
(secondary care) analyser (three improved performance when
consecutive efforts the SRS was worn: Comments:
Inclusion: people with RA referred by a recorded). • Participants were quicker • Participants had been wearing the
rheumatology consultant to occupational with respect to dexterity SRS for 18 months prior to study and
therapy, who had been assessed for, and when SRS was worn; the therefore effect on original deformity
had already purchased, silver ring splints effect was greater in the non- is unknown
dominant hand than the • Did not measure the PIPJ deformity
Exclusion: individuals deemed to be dominant • Immediate impact of splints only and
from a vulnerable group, and who were • Grip strength was greater not long-term
unable to understand English when SRS was worn. • Mean duration of splint wear given as
18 hours/day (SD 10) but no further
8 participants breakdown, e.g. day/night use, so
Male:female ratio = 1:7 cannot tell if exposure is similar or
Mean age = 63 years (range not given) not for all participants
Hand dominance: right (100%) • No indication of how much time
elapsed after removal of the SRS
All participants had already been before measurements were taken,
wearing the splints for at least 18 nor if/how long possible benefits of
months SRS may endure after removal.

United Kingdom.
­123
­124

Source Design and participants Intervention Outcome Results Quality and comment
Tada et al Prospective study A ring-like tin splint that Participants were measured Pain decreased at all Grade D – Very Low
(2018) restricted the motion of at baseline and after 1, 3 and measurement points, but
Aim: to test effectiveness and participant the DIP joint was worn by 6 months of splint use significantly so after 1 month Downgraded due to:
satisfaction of a tin ring splint participants (p<0.001, 95% CI = +/−4.5) • Risk of bias due to not
Pain was measured via the specifying how participants
Inclusion: people with painful Frequency or duration of Numeric Pain Scale (NPS) Active arc of motion did not recruited or who took the
osteoarthritis (OA) of the distal use was not specified, change significantly, though it measurements and how the
interphalangeal (DIP) joint except to say to wear or Active arc of motion of the did increase follow-up data was obtained
remove it freely DIP joint
Exclusion: people with secondary joint depending on pain Function increased, with Comments:
deformation due to comorbid conditions severity. Function of the upper significant improvement seen at • Limitations include no
or severe deformations with joint extremity was measured 6 months (p<0.001, 95% CI = control group, not
subluxation, or those who received intra- through the Hand 20 +/−3.2) examining the influence of
articular injections of steroids or the severity and duration of
hyaluronic acid formulations within the Treatment satisfaction was Treatment satisfaction ranged OA on the treatment
Hand and wrist orthoses for adults with rheumatological conditions

last 6 months rated on a 10-point scale (10 from 7.8 at months 1 and 6 to outcome, small number of
= completely satisfied) 7.7 at 3 months cases.
30 participants
Male:female ratio = 1:14 Satisfaction with ease of Participants rated usability
Mean age = 68 years wearing the splint and its 8.9/10 and cosmetic appeal
cosmetic appeal was rated on 7.6/10
Japan. a 10-point scale (10 =
completely satisfied) after 1 Participants wore the splint for
month of wear an average of 6.2 days/week at
1 month, 4.7 days/week at 3
Frequency of wearing the months and 3.8 days/week at 6
splint was asked in the last months.
week of wear.
Royal College of Occupational Therapists 2020

Source Design and participants Intervention Outcomes Results Quality and comment

Thiele et al Cross-over trial Use of a custom-made Assessed at baseline and after Pain: statistically significant Grade C – Low
(2009) leather splint versus a each 2-week splint phase by decrease in pain for both
Aim: to compare the effectiveness of commercially available observer blinded to treatment splints but more so for leather Downgraded from A due to
two splint types on pain and hand fabric splint allocation splint limitations:
function in adults with chronic wrist • No information provided about
pain Wrist extension 15–20° Hand function, stiffness and Stiffness: leather splint period of recruitment or issue of
pain: demonstrated significant power calculation to guide
Recruitment from a single Splint fitted by • Australian/Canadian reduction in stiffness but numbers needed to treat
occupational therapy outpatient occupational therapist Osteoarthritis Hand Index fabric splint did not; no • Many variables – e.g. length of
department – 38 potential (AUSCAN) – VAS (10 cm) significant difference in effect wearing time variable not
participants identified Each splint worn for 2 reference to previous 48 between the splints accounted for
weeks with 1-week hours • Used AUSCAN, which has been
Participants randomly assigned in washout period Function: both splints validated for use with people with
two-phase cross-over trial Self-perceived occupational produced a statistically OA; however, this trial includes a
Total trial duration 5 performance in ADL: significant improvement in high percentage of participants
Inclusion: chronic wrist pain impairing weeks. • COPM function, with little difference with RA, therefore the results
functional activity between the splints from AUSCAN outcome measure
Power grip strength: could be considered not to be as
Exclusion: under 18 years of age; • Jamar® dynamometer Grip strength: noted as valid
significant comorbidities; seeking achieving a statistically • No control group, therefore
compensation or likely to have a Splint preference. significant increase for both unable to ascertain true
change in pharmacological regimen groups (p<0.001) treatment effects: e.g. no wearing
times included, i.e. participants
Male:female ratio = 12:13 Indicated that for the short- controlled this variable
Mean age = 54 years (18–82) term relief of pain and • Effect sizes are given but not
Mean disease duration = 15 (1–58) dysfunction, the leather wrist confidence levels
splint was superior to a • No outcomes measured after first
OA 24% commercially available fabric arm of cross-over trial, which
RA 68% splint. limited the ability to account for
Other inflammatory disease 8% carryover effect
• Not large enough sample to
Australia. generalise the analysis of
comparative data between the
two splints
• No mention of aesthetic
preference, though the custom
moulding of the leather splint
may have led to its higher rating
with participants.
­125
­126

Source Design and participants Intervention Outcomes Results Quality and comment

Veehof et Randomised controlled trial Intervention group: Baseline and after 4 Mean duration of wear (SD) = 11.4 hours Grade B – Moderate
al (2008a) commercially available weeks per day (2.5)
Aim: to investigate the efficacy of prefabricated wrist splint Downgraded from A due to
wrist working splints after a period of fitted for more affected Primary outcome: Pain: intervention group score decreased limitations:
splinting in people with RA wrist by an occupational • Wrist pain – VAS (100 by 32% after 4 weeks but increased by • Sample size too small to
therapist mm) 17% in the control group. The effect size offer statistical significance
Four-week RCT among 33 people with (Hedges’ g=−1.24) indicated a large and did not meet the
RA with wrist arthritis Wrist extension 10–20° Secondary outcome: treatment effect on VAS-measured pain required power
• Grip strength – (p=0.002) calculations for the primary
Single outpatient clinic and selected Choice of four different dynamometer outcome measure selected
by the rheumatologist splints, all with fabric (Vigorimeter) Pain on function: SODA-S results found • Selection of wrist with
gauntlet and removable • Functional ability – activities painful to undertake decreased more symptoms was
Inclusion: recognised diagnosis of RA; volar metal stay – choice DASH and short by 30% in the intervention group interesting – but hand
signs of active arthritis of wrist due to provided to enhance fit version of the SODA compared to 6% in the control group. dominance could be
RA; painful wrist; stable drug regimen (SODA-S) This was not significantly different in the important in relation to the
and no anticipated changes in 4-week Requirement to wear the two groups, therefore small treatment outcomes measured
period splint as much as Tests for performance effect (Hedges’ g=−0.45) • Selection by the
possible, especially during were conducted without rheumatologist for trial
Exclusion: recent injection of activities, and to keep a the splint Grip strength: no significant differences participation could have
corticosteroid; severe deformities; daily diary and small treatment effect. Mean grip introduced bias
Hand and wrist orthoses for adults with rheumatological conditions

wearing a pre-existing splint; carpal Participants’ perceived strength scores slightly increased in • Non-blinded trial
tunnel syndrome or other Educational and changes: 5-point scale, at intervention group • ‘Usual care’ not defined.
neurological deficit behavioural strategies end of the 4-week trial
were applied period. Functional ability: DASH and SODA-S
Intervention group of 17 participants: slightly improved in both groups; no
Male:female ratio = 5:12 Control group: received significant differences and treatment
Mean age (SD) = 60.3 years (10.8) usual care, though were effect small (Hedges’ g≤0.34)
Mean disease duration = 8.2 years offered a splint on
(6.8) conclusion of the study. Participant-perceived changes: significant
difference in splinted group, who
Control group of 16 participants: perceived their pain and function to have
Male:female ratio = 5:11 improved compared to the control group
Mean age (SD) = 55.1 years (12.8) (p≤0.01)
Mean disease duration = 5.0 years
(4.6) Little harm likely; low-cost intervention.

Netherlands.
Royal College of Occupational Therapists 2020

Source Design and participants Intervention Outcomes Results Quality and comment

Veehof et al Qualitative study – semi- Fabric working wrist splints Factors that influence Factors influencing splint use: majority of Grade C – Low
(2008b) structured interviews reasons for using splints participants indicated dependence on the
Interview at home by an and limitations regarding seriousness of their symptoms (pain, Comments:
Aim: to evaluate participant independent researcher them swelling, or tingling feelings) • No ethical approval
motivations for and perceived sought/mentioned
barriers to using their wrist Mean interval between Participants’ motivations Reasons to wear splint: reduction of • No triangulation of
working splint splint prescription and for, and perceived barriers symptoms, wrist support, and results or respondent
interview (SD) = 6.0 months to, using working wrist immobilisation of the wrist validation mentioned
Identified through hospital files (3.5) splints for RA • Splints were provided by
and contacted by consultant Reasons not to wear splint included: rheumatologists, which is
rheumatologist Fabric wrist splints – two The interview transcripts reduced functional abilities, activity- usual practice in the
types used were analysed using the related, e.g. wet or dirty tasks, Netherlands; may not be
20 of the 57 contacted consented framework approach. inconvenience, long drying time, sweating, usual practice in United
to be interviewed. Two interviews 16 received a Rolyan® wear and tear Kingdom as splints can
were used as pilot interviews and D-ring and 2 participants be provided by a range
were excluded from further received a FuturoTM splint. Reference was made to side effects: of healthcare
analysis unpleasant feelings such as tingling, or professionals
pressure points due to tight fit • Length of time the splint
Inclusion: adult, RA, in receipt of had been prescribed
a fabric wrist working splint Themes in results: before the interview
between 1 and 12 months • Prescription and knowledge varied from 1–12
previously because of pain from • Splint use months.
wrist arthritis • Advantages
• Disadvantages
Participants = 18 • Expectations
• Appearance, comfort and fit
Male:female ratio = 4:14 • Social environment
Mean age (SD) = 56.3 years (16.4)
Decisions by individuals whether to wear
Netherlands. or not wear a working splint are
intentional

Authors have developed educational and


behavioural strategies with the aim of
increasing adherence to wearing splints.
­127
­128

Source Design and participants Intervention Outcomes Results Quality and comment
Vegt et al (2017) Multicentre, cross-over randomised One orthosis was off the • Pain measured via a 10 cm 59 participants completed the Grade B – Moderate
controlled trial shelf, semi-rigid and visual analogue scale study
immobilised the CMC-1 • Hand function assessed Downgraded due to:
Aim: to compare the Push Ortho Thumb joint (PB) using the Jebsen Taylor There was no significant difference • Insufficient washout
Brace CMC and a custom-made orthosis Hand Function test, Nine in pain reduction between the two effects for 2 of the
for treatment of primary osteoarthritis Second orthosis was Hole Peg Test (NHPT), key orthoses. Participants reported outcome measures,
of the carpometacarpal joint of the custom-made, rigid and grip, pinch grip and less pain with both, though this potential recruitment
thumb (CMCOA) immobilised both the functional Index for Hand was more significant with the off- bias, that only people
CMC-1 and MCP-1 joint Osteoarthritis the-shelf orthosis (p=0.008) with symptomatic
Recruitment via rehabilitation • Satisfaction and CMCOA who
physicians, plastic and orthopaedic Participants stratified by preference measured via NHPT times improved with both requested treatment
surgeons, rheumatologists and hand radiographic stage, and the Dutch version of the orthoses, but this reduction was were studied,
therapists across three sites from Sept. all used both orthoses Quebec User Evaluation of significantly greater with the meaning results may
2013 – Nov. 2014 for 2 weeks with a Satisfaction with Assistive custom-made orthosis (2 seconds not be applicable to
washout period of 2 Technology score. versus 0.6 seconds, p<0.001) all people with
Inclusion: over 18 years of age, weeks CMCOA, and
diagnosis of primary CMCOA confirmed Key grip strength was reduced stopping recruitment
by clinical history, examination and Coin toss determined significantly more with the early on because
Hand and wrist orthoses for adults with rheumatological conditions

radiograph of the hand which orthosis was worn custom-made orthosis (0.9 kg power calculations
first versus 0.4 kg, p=0.001) suggested large
Exclusion: secondary CMCOA, previous numbers required to
surgery for CMCOA, corticosteroid Neither assessors nor 68% preferred the off-the-shelf detect a difference
injection in the CMC-1 joint in the patients were blind to orthosis, 13% the custom-made between the two
preceding 6 months, other local medical treatment. and 19% either. orthoses.
conditions that might interfere with the
study results, such as rheumatoid
arthritis

63 participants
Male:female ratio = 5:11
Mean age = 60.1

The Netherlands.
Royal College of Occupational Therapists 2020

Source Design and participants Intervention Outcomes Results Quality and comment

Wajon and Randomised controlled trial Intervention group: Measured by a blinded No difference was found between the Grade A – High
Ada (2005) custom-made assessor at weeks 0, 2, intervention and control groups in the
Aim: to compare the effects of two thermoplastic thumb and 6 extent of mean improvement at 2 weeks or Comments:
6-week splint and exercise regimens strap splint plus 6 weeks for pain, pinch strength or hand • No record of compliance
for individuals with abduction exercises • Pain: VAS (10 cm) at function during the trial
trapeziometacarpal OA rest • Lack of statistical power
Control group: After 6 weeks of intervention, outcomes had in the numbers in trial
Referred to hand physiotherapy short opponens thumb • Strength: tip pinch in improved with both splint groups means that results need
practice splint including MCPJ kilograms – pinch to be interpreted with
and pinch exercises gauge Considered together: caution
Inclusion: pain at base of thumb, • Pain had decreased on the VAS by a • Not long-term enough –
Stage I–III trapeziometacarpal OA Two-week period of • Hand function: mean of 2.1 cm (p<0.01) only 6-week follow-up; a
splinting followed by a Sollerman Test of • Strength had increased for tip pinch by a relatively short duration
Exclusion: De Quervain’s tendonitis; 4-week period of Hand Function scored mean of 0.6 kg (p<0.01) of splint use to draw
carpal tunnel syndrome; wearing the splint and out of 80. • Hand function improved by a mean of 6.5 conclusions of effects of
scapholunate instability; trigger incorporating the points on the Sollerman Test of Hand splint alone, but
thumb; steroid in preceding 6 addition of exercise Function (p>0.01) pragmatic to include
weeks; previous surgery effect of exercises as well
Instructed to wear splint While both groups improved, neither • Data analysis did not
40 participants full time and remove for splint nor exercise regimen was superior include assessing for
personal hygiene only. to the other in participants with normal distribution
Intervention group: trapeziometacarpal OA. Splint and exercise • Sollerman Test of Hand
Male:female ratio = 5:14 choice may therefore take into account Function has a degree of
Mean age (SD) = 59.7 years (9.0) individual requirements such as assessor judgement in
Mean disease duration (SD) = 3.9 occupational needs assigning a score, as tasks
years (5.2) have to be achieved using
One participant had to stop the trial as their the correct hand grip.
Control group: splint was too painful to wear, but this was
Male:female ratio = 4:17 not discussed.
Mean age (SD) = 61.2 years (12.5)
Mean disease duration (SD) = 3.3
years (3.6)

Australia.
­129
­130

Source Design and participants Intervention Outcomes Results Quality and comment

Weiss et al Randomised trial/cross-over Two types of thumb Pain with splint usage (VAS) Splints worn on average 8.3 hours per day Grade C – Low
(2004) design splint: for the CMT and 9.1 hours per day for the
Pain with pinch testing PFN Downgraded from A due to
Aim: to assess the level of Prefabricated neoprene (VAS) limitations:
pain, pinch strength, CMCJ splint that included the Pain at rest: statistically significant results • Potential of reporting bias and
stability, functional effects, CMC and Functional abilities while reached for pain improvement at rest after imprecise treatment effects due
satisfaction and preference metacarpophalangeal wearing each splint (self- using PFN compared to the CMT (p=0.019), to small sample with short
after the use of both a joint (PFN) report rating scale devised but both splints provided significant thumb follow-up period
prefabricated neoprene by the authors) pain relief after wearing (CMT p=0.002, PFN • Small population: cross-over
splint and a custom-made Custom-made short p<0.001) design has some benefits but a
thermoplastic splint opponens thermoplastic Satisfaction with splints three-arm trial might have
(CMT) supporting the – splint preference (VAS) Pinch strength: improvement in strength produced more reliable results
Participants acted as ‘own CMC joint and pain reduction during pinch greater • Splint order may have influenced
controls’ CMC joint stability using with the PFN splint (p=0.012 and p=0.002) splint preference
Worn for 1 week each, radiographic imaging • One splint did not include the
Inclusion: Stage 1 or 2 OA then subjects swapped techniques in variety of ADLs: easier with the PFN; more than twice MCP, which influenced splint
base of thumb according to splints and used for options – i.e. not loaded as many participants reported that preference
Eaton–Littler classification another week and no splint, to loaded activities were harder with the CMT than • Longer-term use of the splint
and wearing both types of the PFN might have influenced preference
Exclusion: concomitant Regimen – when splint. • Four pinch trials when examining
diagnoses symptoms felt in thumb, Splint satisfaction: PFN rated higher subluxation may have induced
Hand and wrist orthoses for adults with rheumatological conditions

day or night. (p<0.001) on VAS; 72% would prefer PFN fatigue/pain


25 participants for long-term use • Not clear if functional abilities
Male:female ratio 4:21 scale was valid for use in OA
Radiological: subluxation was better • Unclear if assessors independent
Age range not provided but reduced with the CMT (p<0.001) but both of treatment
21 working and 4 retired better when compared with unsplinted • Non-controlled study
views • Small number of participants
Symptoms experienced: (25); no power calculations
48% less than 6 months Splints examined are commonly in use in • Very short wearing period of 1
20% 6 months–1 year occupational therapy in United Kingdom week and no washout period.
32% 1–5 years
Both splints were effective at relieving pain,
United States of America. allowing function and reducing subluxation

Participants preferred the PFN splint, and


the effects on pain, function and pinch pain
were superior.
Source Design and participants Intervention Outcomes Results Quality and comment
Royal College of Occupational Therapists 2020

Zijlstra et al Cohort study Mass-produced silver ring Primary outcome: Total of 72 SRS supplied: 64 for (PIP) joints Grade C – Low
(2004) splints (SRS) from the Silver • Dexterity – the Sequential and 5 for (DIP) joints of fingers, 3 for IP joint
Aim: to study the effect of silver Ring Splint Company in Occupational Dexterity of thumb. Both hands splinted for most Comments:
ring splints in hand function in USA Assessment (SODA) patients. Unable to fit satisfactory SRS for 1 • Pilot study only, so
people with RA or more fingers in 4 participants small sample size
One or more splints fitted Secondary outcomes: • Single centre, single
One-year duration intervention to proximal (PIP) and distal • Grip strength (air bulb 2 participants dropped out because unable assessor
pilot study undertaken in a (DIP) interphalangeal joints manometer), tip pinch to tolerate adverse effects (1 × finger • Does not give a
single rheumatologist’s practice of fingers and IP joint of strength (pinch gauge)– paraesthesia, 1 × rheumatoid nodules). 15 breakdown of the
thumbs. only for hands where SRS completed medications that
Inclusion: RA, stable disease; worn participants took over
finger deformities eligible for • Disease Activity Score Dexterity: SODA scores improved by a mean the period of the
splinting (DAS 28) of 9 points. The difference from baseline study, but did include
• Self-reported hand was statistically significant for participants the DAS 28
Exclusion: not stated function – Dutch Arthritis still wearing their SRS at 3 and 12 months • No blinding of
Impact Measurement (Wilcoxon’s signed rank test 3 months assessors
17 participants Scale 2 (AIMS 2) p=0.005 and 12 months p=0.026) • No controls or
• SODA pain score alternative
Male:female ratio = 3:14 Pain: SODA scores showed no significant intervention arm.
Median age = 65 years (range Recording of number of change
37–74 years) hours used in 1st month,
Disease duration median 21 and at 3 and 12 months, to Grip and pinch: showed no significant
years (range 3–41 years) report if stopped using and change
Hand dominance: all but 1 = reasons. Satisfaction
right-handed. questionnaire also at 3 Hand and finger function: Dutch AIMS 2
months subscale showed slight improvement at 1
Medication did not change month, but this was not statistically
during study period Measured at baseline (T0), 1 significant at 3 and 12 months
month (T1), 3 months (T2)
Netherlands. and 12 months (T3) of SRS 33% of SRS were discarded after 1 year for
use. a number of reasons: inability to tolerate
the SRS, paraesthesia, pressure of the
splints on bony edges or rheumatoid
nodules

At study conclusion, 11 participants would


continue using splint, 2 said not and 2 didn’t
know

Participant satisfaction rating (0–5) of


splints: mean score = 3 (indifferent).
­131
Appendix 7: Outline of other
evidence for orthoses

The following section outlines some of the other evidence found, but for which the
quality or volume did not enable a specific recommendation to be made about the
prescription and use of orthoses.

A7.1 Carpal tunnel syndrome


Carpal tunnel syndrome was included as an alternative condition search term in the
search strategy, as an adjunct to a rheumatological condition. Twenty-one articles in the
first edition’s literature search and 12 in the second edition’s were identified but many
specified an inflammatory condition as an exclusion criterion.

The presentation of carpal tunnel syndrome can be short-lived, in which case, as


inflammation settles, so do carpal tunnel syndrome symptoms. Medication
management can be more appropriate, for example the short-term use of non-steroidal
anti-inflammatory drugs, or surgical decompression to preserve nerve and muscle
function in the long term. Carpal tunnel syndrome pathology in rheumatoid arthritis is
due to inflammation in the wrist or flexor synovitis, both of which present a mechanical
pressure on the median nerve.

Insufficient evidence was identified regarding the impact of orthoses in carpal tunnel
syndrome where there is an underlying inflammatory pathology. A recommendation
could not therefore be made. There is evidence that supports the use of wrist orthoses
in idiopathic carpal tunnel syndrome, and therefore therapists must make a decision
regarding prescription on an individual basis.

A7.2 Trigger finger


The use of orthoses for trigger finger was investigated in studies by Tarbhai et al (2012)
and Colbourn et al (2008), both of which were graded as low quality (Grade C).

Tarbhai’s study was a small randomised controlled trial that compared two orthosis
designs: one metacarpophalangeal joint (MCPJ) based and one distal interphalangeal
joint based. The 28 participants had a variety of underlying pathologies, and seven
individuals had osteoarthritis. After six weeks there was a statistically significant
improvement in pain and in the severity and frequency of triggering in both groups, but
function was not improved. There was no significant difference between the two splints,
although the metacarpophalangeal joint orthosis was reported to be more comfortable.

Colbourn’s cohort study involved 28 participants who wore a custom-made


thermoplastic splint to limit MCPJ flexion, day and night, for a period of six weeks.
Improvements were found in stages of stenosing tenosynovitis, pain and number of
triggering events. Grip strength did not significantly change. Adherence was an issue, in
that 57% of participants reported that they did not wear the orthosis continuously, and
only 35.7% completed the exercises prescribed.

­132 Hand and wrist orthoses for adults with rheumatological conditions
Appendix 7: Outline of other evidence for orthoses

In practice, orthoses may be prescribed prior to other treatments, such as steroid


injections or surgery.

A7.3 Boutonnière deformity and ulnar deviation


There was insufficient published evidence identified to develop any recommendations
with respect to orthotic prescription for the treatment of Boutonnière deformity or ulnar
deviation. Some evidence was included in the 2003 splinting clinical guideline (NAROT
2003a), but the limited more recent research findings may reflect changes in the
pharmacological management and subsequent reduction in the presentation of these
deformities seen as a result of rheumatoid arthritis.

Royal College of Occupational Therapists 2020


­133
Appendix 8: Glossary and abbreviations

ACR American College of Rheumatology


The ACR represents over 9,400 rheumatologists and rheumatology
health professionals around the world. The ACR offers its members
the support they need to ensure that they are able to continue their
innovative work by providing programmes of education, research,
advocacy and practice support.
http://www.rheumatology.org/ACR/about/
ADL Activities of daily living.
Assistive ‘A variety of implements or equipment used to aid patients/clients in
devices performing tasks or movements.’
Quick reference dictionary for occupational therapy: Jacobs and Jacobs
2009
AUSCAN Australian/Canadian Osteoarthritis Hand Index
http://womac.com/auscan
Information re measures of hand function: Poole 2011
BAHT British Association of Hand Therapists
BAHT is a registered UK charity and clinical interest group for
anyone interested in the rehabilitation of hands. BAHT aims to
support members in their professional development as hand
therapists, including the progression of specialist knowledge, clinical
skills and their understanding of the profession.
http://www.hand-therapy.co.uk
BAOT British Association of Occupational Therapists
BAOT is the professional body for all occupational therapy staff in
the UK.
www.rcot.co.uk
BAPO British Association of Prosthetists and Orthotists
BAPO is the ‘only UK body that represents the interests of prosthetic
and orthotic professionals and associate members to their
employers, colleague Allied Health Professionals and all groups that
are involved in the field of prosthetics and orthotics’.
Prosthetists are ‘autonomous registered practitioners who provide
gait analysis and engineering solutions to patients with limb loss’.
Orthotists are ‘autonomous registered practitioners who provide gait
analysis and engineering solutions to patients with problems of the
neuro, muscular and skeletal systems’.
http://www.bapo.com

­134 Hand and wrist orthoses for adults with rheumatological conditions
Appendix 8: Glossary and abbreviations

BHPR Section British Health Professionals in Rheumatology Section Council


Council BHPR is a committee of the British Society for Rheumatology (BSR)
and brings together all the health professions whose major interest
lies in the care of people with musculoskeletal conditions. Members
come from many professions: nursing, physiotherapy, occupational
therapy, podiatry, psychology, social work, medicine, pharmacy and
others.
https://www.rheumatology.org.uk/about-bsr/who-we-are/committees/
bhpr-section-council
Biologics Biologics are drugs that have been developed in recent years that
can target individual molecules and generally work more quickly
than conventional DMARDs. Biologics are prescribed for those
individuals who have not responded well to other treatments
suitable for their condition.
Anti-TNF drugs are an example of biologics. The protein, tumour
necrosis factor, increases inflammation when excess amounts are
present in blood or joints, therefore anti-TNF drugs target this
protein.
https://www.versusarthritis.org/about-arthritis/treatments/drugs/disease-
modifying-anti-rheumatic-drugs-dmards/
Boutonnière Boutonnière deformity
Condition of the finger characterised by flexion of the PIP joint and
hyperextension of the DIP joint.
Bradley and Adams 2013
CASP Critical Appraisal Skills Programme
The Critical Appraisal Skills Programme supports the development of
skills in the critical appraisal of scientific research, and provides a
number of critical appraisal tools to support this activity (CASP
2013).
http://www.casp-uk.net
CI Confidence interval
‘A way of expressing how certain we are about the findings from a
study, using statistics. It gives a range of results that is likely to
include the “true” value for the population. A wide confidence
interval indicates a lack of certainty about the true effect of the test
or treatment – often because a small group of patients has been
studied. A narrow confidence interval indicates a more precise
estimate (for example, if a large number of patients has been
studied).
‘The confidence interval is usually stated as “95% CI”, which means
that the range of values has a 95 in 100 chance of including the
“true” value. For example, a study may state that “based on our
sample findings, we are 95% certain that the ‘true’ population blood
pressure is not higher than 150 and not lower than 110”. In such a
case the 95% CI would be 110 to 150.’
http://www.nice.org.uk/website/glossary/glossary.jsp
CMCJ/TMCJ Carpometacarpal joint/trapeziometacarpal joint.

Royal College of Occupational Therapists 2020


­135
Appendix 8: Glossary and abbreviations

COPM Canadian Occupational Performance Measure


The COPM is an evidence-based outcome measure designed to
capture a client’s self-perception of performance in everyday living,
over time.
http://www.thecopm.ca
CTS Carpal tunnel syndrome.
Custom-made An orthosis that is made to individual specifications.
DASH Disabilities of the Arm, Shoulder and Hand questionnaire
http://dash.iwh.on.ca
Information re measures of adult shoulder function: Angst et al 2011
DIPJ Distal interphalangeal joint.
DMARDs Disease-modifying anti-rheumatic drugs
Pharmacological intervention that alters the underlying disease
rather than treating the symptoms. DMARDs slow down the disease
and its effect on the joints, with the result that pain, swelling and
stiffness are reduced over a period of weeks or months.
Conventional DMARDs are a group of drugs which are slow-acting
and can take several weeks to work (see also Biologics).
https://www.versusarthritis.org/about-arthritis/treatments/drugs/disease-
modifying-anti-rheumatic-drugs-dmards/
Dynamometer An instrument used to measure the maximum isometric strength of
the hand and forearm muscles.
EULAR European League Against Rheumatism
EULAR is the organisation that represents the patient, health
professional and scientific societies of rheumatology of all the
European nations. EULAR endeavours to stimulate, promote and
support the research, prevention, treatment and rehabilitation of
rheumatic diseases.
http://www.eular.org
GRADE Grading of Recommendations Assessment, Development and
Evaluation
GRADE is a systematic and explicit methodology to assist in the
judgement of the quality and strength of guideline
recommendations.
http://www.gradeworkinggroup.org
Hand function The ability to use the hand in daily activities.
Fowler and Nicol 2001
HCPC Health and Care Professions Council
HCPC is the regulator for 16 health professions, including
occupational therapists.
http://www.hcpc-uk.org
MCPJ Metacarpophalangeal joint.
NAROT National Association of Rheumatology Occupational Therapists
(NAROT) became known as the College of Occupational Therapists
Specialist Section – Rheumatology, and more recently the RCOTSS –
Rheumatology Clinical Forum.
Neoprene A synthetic rubber with elastic properties that is covered by fabric
when used for orthosis fabrication.

­136 Hand and wrist orthoses for adults with rheumatological conditions
Appendix 8: Glossary and abbreviations

NHS National Health Service


The NHS refers to the publicly funded healthcare system in the UK.
NICE National Institute for Health and Care Excellence
NICE (formerly the National Institute for Health and Clinical
Excellence) provides national guidance and advice to improve health
and social care.
http://www.nice.org.uk
NRAS National Rheumatoid Arthritis Society
NRAS provides information and support for people with rheumatoid
arthritis and juvenile idiopathic arthritis, their families, friends and
carers, and health professionals with an interest in rheumatoid
arthritis.
http://www.nras.org.uk
NRS Numeric Rating Scale – Pain
Gives information on measures of adult pain.
Hawker et al 2011
NSAIDs Non-steroidal anti-inflammatory drugs.
OA Osteoarthritis.
Orthoses Plural term for orthosis.
Orthosis Externally applied device used to modify the structural and
functional characteristics of the neuromuscular and skeletal
systems.
International Organization for Standardization 1989
Orthotic Word used as an adjunctive/descriptive term, i.e. an orthotic
department, an orthotic intervention.
Oval-8® Thermoplastic three-point orthosis used as an intervention for swan
neck deformity.
Bradley and Adams 2013, p202
p values Probability
‘The p value is a statistical measure that indicates whether or not an
effect is statistically significant.
‘For example, if a study comparing two treatments found that one
seems more effective than the other, the p value is the probability of
obtaining these results by chance. By convention, if the p value is
below 0.05 (that is, there is less than a 5% probability that the
results occurred by chance), it is considered that there probably is a
real difference between treatments. If the p value is 0.001 or less
(less than a 1% probability that the results occurred by chance), the
result is seen as highly significant.
‘If the p value shows that there is likely to be a difference between
treatments, the confidence interval describes how big the difference
in effect might be.’
Glossary: http://www.nice.org.uk/website/glossary/glossary.jsp
Pinch gauge An instrument that measures finger pinch strength.
PIPJ Proximal interphalangeal joint.
Prefabricated An orthosis manufactured in advance and ready to be fitted to an
individual.
RA Rheumatoid arthritis.

Royal College of Occupational Therapists 2020


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Appendix 8: Glossary and abbreviations

RCT Randomised controlled trial


‘A study in which a number of similar people are randomly assigned
to two (or more) groups to test a specific drug or treatment. One
group (the experimental group) receives the treatment being tested,
the other (the comparison or control group) receives an alternative
treatment, a dummy treatment (placebo) or no treatment at all. The
groups are followed up to see how effective the experimental
treatment was. Outcomes are measured at specific times and any
difference in response between the groups is assessed statistically.
This method is also used to reduce bias.’
Glossary: http://www.nice.org.uk/website/glossary/glossary.jsp
RCOT Royal College of Occupational Therapists
The Royal College of Occupational Therapists is a wholly owned
subsidiary of BAOT and operates as a registered charity. The College
sets the professional and educational standards for the occupational
therapy profession and represents the profession at the national
and international levels.
https://www.rcot.co.uk/about-us/governance/how-we-are-run
RCOT Royal College of Occupational Therapists Rheumatology Clinical
Rheumatology Forum
Clinical Forum The Rheumatology Clinical Forum is part of the RCOTSS – Trauma
and Musculoskeletal Health and is the forum for occupational
therapists working in, or with an interest in, rheumatology and
musculoskeletal health.
https://www.rcot.co.uk/about-us/specialist-sections/trauma-and-
musculoskeletal-rcot-ss/clinical-forums
RCOTSS – Royal College of Occupational Therapists Specialist Section –
Trauma and Trauma and Musculoskeletal Health
Musculo- RCOTSS – Trauma and Musculoskeletal Health is a branch of the
skeletal College. It provides professional and clinical information on all
Health aspects of occupational therapy practice related to trauma,
orthopaedics and rehabilitation, including amputations.
https://www.rcot.co.uk/about-us/specialist-sections/trauma-and-
musculoskeletal-rcot-ss
ROM Range of movement.
SIGN Scottish Intercollegiate Guidelines Network
SIGN develops evidence-based clinical practice guidelines for the
National Health Service (NHS) in Scotland.
http://www.sign.ac.uk
SODA/SODA-S Sequential Occupational Dexterity Assessment
SODA-S is the shortened version of this assessment. Lankveld et al
1996
Spica orthosis Orthosis used to immobilise the thumb and/or wrist.
Splint See orthosis.
SRS Silver ring splint
A bespoke orthosis made of silver as an intervention for swan neck
deformity.
Bradley and Adams 2013, p197

­138 Hand and wrist orthoses for adults with rheumatological conditions
Appendix 8: Glossary and abbreviations

Swan neck Condition of the finger characterised by hyperextension of the PIP


deformity joint and flexion of the DIP joint.
Bradley and Adams 2013
Thermoplastic A material that becomes soft when heated, can be moulded and
becomes hard when cooled.
Thumb base First carpometacarpal joint with or without scapho-trapezoid joint
OA osteoarthritis.
Zhang et al 2009
Trigger finger ‘A phenomenon in which the movement of a finger is halted
momentarily in flexion or extension and then continues with a jerk.’
Mosby’s medical, nursing and allied health dictionary: Anderson 2002
Ulnar Deviation of the MCPJ due to capsular attenuation and joint
deviation destruction.
Bradley and Adams 2013, p196
VAS Visual Analogue Scale
A VAS is a continuous scale, consisting of a horizontal or vertical line
(usually 10cm in length), which is anchored by two verbal descriptors
that describe extremes of a symptom, for example pain intensity.
Hawker et al 2011
Versus Versus Arthritis, formed in 2018, is a charity that funds high-quality
Arthritis research, educates healthcare professionals, lobbies government,
and provides information to people with arthritis and their carers. It
builds upon the legacies of Arthritis Research UK and Arthritis Care.
https://www.versusarthritis.org
Washout The period during a clinical study when the participants do not
period receive any treatment that is under investigation.
Wearing The frequency and duration of suggested orthosis wear.
regimen

All websites in the glossary were accessed on 20.07.20.

Royal College of Occupational Therapists 2020


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Royal College of Occupational Therapists 2020


­149
Addendum to Hand and wrist orthoses for adults
with rheumatological conditions: Practice
guideline for occupational therapists, second
edition
October 2022

Introduction
New research on the clinical and cost-effectiveness of compression gloves published after a review
of this guideline has necessitated an amendment to the 2020 edition.

In order to comply with its NICE-accredited process for managing published guidelines, the Royal
College of Occupational Therapists (RCOT) carries out a monitoring search once a year after
publication of a guideline to determine if new evidence has emerged that significantly impacts on the
recommendations. These monitoring searches replicate the literature search conducted during the
guideline development process, though only include the EBSCO and Ovid platforms. Literature
results are then screened by RCOT members with knowledge of the clinical area and guideline
recommendations to assess the potential significance of the results. It was during this process that
new research on compression gloves (Hammond et al 2021) was noted for its significant findings.

Members of the original Guideline Review Group met to discuss the implications of this evidence,
and agreed that the research was robust (via two independent critical appraisals) and the findings
significant, necessitating amendments to the 2020 edition of the guideline. The recommendation
and suggestion below were drafted and approved by volunteer members of the Guideline Review
Group. On 26 September 2022 the RCOT Publications Group approved these changes to the
guideline.

Background

To date, occupational therapists have routinely recommended compression gloves for people with
rheumatoid arthritis or other forms of hand arthritis. As noted in the guideline, evidence on their
effectiveness was limited, with little explanation of how they potentially benefitted those who wore
them.

This new research by Hammond et al provides significant evidence that compression gloves should
not be regularly prescribed to improve hand pain, function or stiffness, as has historically happened.

Addendum to Hand and wrist orthoses for people with rheumatological conditions: practice guideline for
occupational therapists, second edition. 3 October 2022. 1
Recommendations
The following are in addition to the recommendations in the main guideline:
https://www.rcot.co.uk/file/526/download?token=LzL3fvdP

Compression gloves
9. It is recommended that occupational therapists do not prescribe arthritis 1A
gloves providing pressure for hand pain, function or stiffness.

(Hammond et al 2021 [A])


[New recommendation 2022]

10. It is suggested that occupational therapists consider the perceived 2A


benefits that a loose-fitting, three-quarter finger length glove might provide
for warmth, comfort and support.

(Hammond et al 2021 [A])


[New suggestion 2022]

Evidence

A randomised controlled trial carried out by Hammond et al (2021) investigated the clinical and
cost-effectiveness of compression gloves. Participants, recruited from six NHS sites across
Scotland and England, had a confirmed diagnosis of rheumatoid arthritis or undifferentiated
inflammatory arthritis and were randomised into two groups. The intervention group was correctly
fitted with Isotoner® compression gloves, while the control group was fitted with Jobskin® classic
oedema gloves that were one size too large to ensure lack of compression. Therapists and
participants were not blind to treatment, but participants were told that the purpose of the study was
to understand the difference between two different types of arthritis gloves. Participants could wear
the gloves day and night but were advised not to wear either glove for the full 24 hours. Both groups
received usual care in addition to the gloves.

At 12 weeks’ follow-up, both groups showed a reduction in pain in their dominant hand while doing
moderate daytime activities. However, no significant difference in change was detected between the
two groups, providing evidence that a loose-fitting glove could be as effective as a correctly fitted
compression glove. Additionally, more participants in the intervention group reported adverse effects
than in the control group. No significant differences were found between groups in glove wear or
any secondary outcome measures, such as night pain in their dominant hand, function or stiffness.
The majority in both groups perceived the gloves as beneficial, providing warmth and comfort. The
study did not find compression gloves to be cost-effective because they were no more effective than
placebo gloves.

For further details, see the evidence table on page 4 of this addendum and read the full article.

Evidence summary

The evidence for this recommendation and suggestion is provided by one high-level randomised
controlled trial with few limitations. It is based on a UK population that is relevant to the guideline
and generalisable to occupational therapy practice.
Addendum to Hand and wrist orthoses for people with rheumatological conditions: practice guideline for
occupational therapists, second edition. 3 October 2022.
2
Future research recommendations

It would be helpful for future research to investigate whether loose-fitting gloves provide any benefits
to people with rheumatoid arthritis, with a particular focus on whether loose-fitting gloves improve
pain, function, stiffness or oedema. Additionally, future research should explore whether
compression gloves reduce oedema.

Evidence reference

Hammond A, Prior Y, Cotterill S, Sutton C, Camacho E, Heal C … Firth J (2021) Clinical and cost
effectiveness of arthritis gloves in rheumatoid arthritis (A-GLOVES): randomised controlled trial with
economic analysis. BMC Musculoskeletal Disorders, 22(1), 47. Available at:
https://bmcmusculoskeletdisord.biomedcentral.com/articles/10.1186/s12891-020-03917-8

© 2022 Royal College of Occupational Therapists. The Royal College of Occupational Therapists (or RCOT)
is a registered charity in England and Wales (275119) and in Scotland (SCO39573) and a company registered
in England (No.134734). VAT Reg. No. 242 7829 47

Isotoner® is a registered trademark of totes Isotoner Corporation


Jobskin® is a registered trademark of Medigarments Ltd

Addendum to Hand and wrist orthoses for people with rheumatological conditions: practice guideline for
occupational therapists, second edition. 3 October 2022.
3
Source Design and participants Intervention Outcomes Results Quality and comment
Hammond Randomised controlled trial. • Participants were randomly • Primary outcome measure was • While both groups showed Grade A – High
et al (2021) assigned to intervention or pain in the dominant hand pain reduction in the
Aim: to compare the clinical and control group. during moderate daytime dominant hand, there was no Comments:
cost-effectiveness of compression • Therapists were not blinded to activities measured on a significant difference between
gloves for people with rheumatoid allocation, and participants numeric rating scale. Pain was the change in the intervention • Limitations include the
arthritis (RA) or undifferentiated were told the study was measured at 12 weeks post- group compared with the impossibility of blinding
inflammatory arthritis (UIA) investigating two types of randomisation. change in the control group. therapists to treatment, not
compared with placebo gloves. arthritis gloves. • Secondary outcome measures • No substantive difference in having a third group
• Intervention group received were: dominant hand pain at amount of glove wear consisting only of usual
Recruitment: via 16 NHS sites in correctly fitting ¾ length finger night, non-dominant hand pain between the groups. care, and not having an
England and Scotland, identified by Isotoner® gloves. at day and night (all measured • No statistically significant objective clinical
consultants. • Control group received ¾ length through a numeric rating scale), differences were found assessment of hand
finger Jobskin® classic oedema duration of early morning hand between groups for any of the function.
Inclusion: people 18 years or older gloves, fitted one size too large. stiffness, hand function via the secondary outcomes.
diagnosed with RA or UIA with • All participants could not wear Measure of Activity • Over 70% of both groups
persistent pain in the proximal the gloves for a full 24 hours Performance Hand, hand perceived gloves as
interphalangeal joints (PIPJs) or per day. performance via the Michigan beneficial, gave warmth and
metacarpophalangeal joints • Both groups received usual Hands Outcome Questionnaire, comfort, and that they would
(MCPJs) causing at least one of: care. disability via the Health continue to wear them.
difficulty using the hands during Assessment Questionnaire, • 47 participants in the
the day; disturbed sleep; limited health benefit for the economic intervention group reported
ability to use the hands in the evaluation via the EQ-5D-3L, adverse effects compared
morning. and reported use of health and with 36 in the control group.
social care services. All were • Intervention gloves cost more
Exclusion: diagnosed with other asked at baseline and 12 weeks but were no more beneficial
inflammatory forms of arthritis post-randomisation. than placebo gloves, making
affecting the hands; severe • At 12 weeks post- them unlikely to be cost-
Raynaud’s disease, hand circulatory randomisation, participants were effective.
disturbances, hand neuropathies or asked about glove use,
hand deformities; and any perceptions of glove wear, and
contraindications to glove-wear, nor new steroid prescription.
should participants have previously • Therapists recorded glove
worn compression gloves. provision, wear regimen and
occupational therapy provided
206 participants with 163 as part of usual care on
completing. standardised treatment logs.
Control group (completing): n=79
Intervention group (completing):
n=84.
Mean age (SD) = 59 years.

UK.

Addendum to Hand and wrist orthoses for people with rheumatological conditions: practice guideline for occupational therapists, second edition. 3 October 2022. 4
Hand and wrist orthoses for adults
with rheumatological conditions
Practice guideline for occupational therapists
Second Edition

This publication provides specific evidence-based


recommendations which describe the most appropriate
care or action to be taken by occupational therapists
working with adults who may benefit from a hand or
wrist orthosis as an intervention for a rheumatological
condition. Physiotherapists, hand therapists, orthotists
and others who prescribe or use othoses may also wish
to refer to the guideline to inform their practice.

ISBN 978-1-913496-01-2

Available
for Download
rcot.co.uk
Available
Tel: 020
for3141 4600
Download
© 2020 Royal College of Occupational Therapists Ltd. A registered
charity in England and Wales (No. 275119) and in Scotland
(No. SCO39573) and a company registered in England (No. 1347374)
Available
for Download

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