Proof: Journal of Bodywork & Movement Therapies
Proof: Journal of Bodywork & Movement Therapies
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Original Research
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Sandro Groisman a ,b ,∗ , Tais Malysz c ,d , Luciano de Souza da Silva b , Tamara Rocha Ribeiro Sanches b ,
Karoline Camargo Bragante a , Franciele Locatelli b , Cleder Pontel Vigolo b , Simone Vaccari b ,
Cristina Homercher Rosa Francisco b , Simone Monteiro Steigleder b , Geraldo Pereira Jotz a ,d
a Graduate Program in Health Sciences, Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA), Porto Alegre, Brazil
b
Instituto Brasileiro de Osteopatia (IBO), Brazil
c Graduate Program in Neuroscience, Universidade Federal do Rio Grande do Sul (UFRGS), Porto Alegre, Brazil
D
d Department of Morphological Sciences, Universidade Federal do Rio Grande do Sul (UFRGS), Porto Alegre, Brazil
were obtained by the use of Numeric Pain-Rating Scale (NPRS), Pressure Pain Threshold (PPT) and Neck Disabil-
Keywords ity Index (NDI). Secondary outcomes included range of motion (ROM) for cervical spine rotation, Fear-Avoid-
Osteopathy ance Beliefs Questionnaire Work/Physical Activity (FABQ-W/PA) and Pain-self efficacy at two different moments:
Osteopathic manipulative treatment baseline and 4 weeks after the first treatment. Techniques and dosages of OMT were selected pragmatically by
Musculoskeletal manipulations a registered osteopath. Generalized Estimating Equations model (GEE), complemented by the Least Significant
Manual therapy Difference (LSD) and the intention-to-treat analysis, was used to assess the clinical outcomes.
Disability Results: Analysis with GEE indicated that OMT/EG reduced pain and disability more than the EG alone after 4
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Neck pain
weeks of treatment with statistically significant difference (p < 0,05), as well as cervical active rotation was sig-
nificantly improved (p = 0.03). There were no between-group differences observed in Pressure Pain Threshold
(PPT) measure, Fear-Avoidance Beliefs Questionnaire and Pain-self efficacy.
Conclusion: The association between OMT and exercises reduces pain and improves functional disability more
than only exercise for individuals with non-specific chronic neck pain.
© 2019
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1. Introduction Since the cause of pain is unknown in most cases, neck pain is la-
beled as non-specific chronic neck pain (NCNP) (Hidalgo et al., 2017).
Neck pain is a common condition with a reported prevalence ranging However, several factors may contribute to NCNP, such as mechanical
from 22% to 70% among the general population, and it is more com- and biological aspects (age, gender, history of trauma and musculoskele-
mon in women than in men (Blanpied et al., 2017). Neck pain, as well tal diseases), and other factors related to psychosocial characteristics
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as low back pain, is the leading cause of disability measured in years (physical activity, beliefs, expectations and job satisfaction). These fac-
lived with disability (L. Carroll, 2000; Hogg-Johnson et al., 2008; tors are known as having an influence on the transition from acute to
Palmer et al., 2001; Vos et al., 2016). Studies show that up to 54% chronic pain (Bronfort et al., 2001; Curatolo et al., 2011; Hidalgo
of people will suffer from cervical pain at some point in their lives, and et al., 2017).
almost all of them will still have symptoms during the first five years There are several NCNP management options, including manual
after the first episode of pain (L. J. Carroll et al., 2009; Côté et al., therapy, conventional physiotherapy, drug treatment, exercise, pain ed-
2004; Wright et al., 1999). Consequently, neck pain results in major ucation, among others (Borghouts et al., 1999; Cleland et al., 2005;
health costs, mainly due to absenteeism from work (Blanpied et al., Gross et al., 2015; Lau et al., 2011). Manual therapy is a widely used
2017; Bronfort et al., 2001). approach, and there has been a significant increase in the number of
clinical trials investigating this practice in recent years (Cross et al.,
2011; Miller et al., 2010; Vincent et al., 2013). Although there is
☆ The manuscript submitted does not contain information about medical device(s)/ moderate evidence to support the use of manipulative treatments for
drug(s). cervical pain, the literature shows it is more effective than no inter-
∗
Corresponding author. Doctoral Program in Health Sciences, Universidade Federal de vention or placebo treatment (González-Iglesias et al., 2009; Gross
Ciências da Saúde de Porto Alegre (UFCSPA), Rua Sarmento Leite, 245, 90035-004, Porto
et al., 2010; Schwerla et al., 2008).
Alegre, Brazil.
E-mail address: [email protected] (S. Groisman)
2 S. Groisman et al. / Journal of Bodywork & Movement Therapies xxx (xxxx) 1–7
A combination of several treatment modalities is referred as multi- lowing four criteria from the clinical prediction rule for diagnosis of cer-
modal care. Combined manual therapy and exercises have also led to the vical radiculopathy were also excluded from the study (Wainner et al.,
improvement of patient outcomes when compared to manual therapy or 2003): positive Spurling test, positive distraction test, positive upper
exercises alone (Walker et al., 2008). limb tension test A, and ipsilateral cervical rotation less than 60°. In-
Osteopathic manipulative treatment (OMT) is a noninvasive ap- dividuals that reported previous cervical surgery, previous history and
proach that incorporates manual diagnostic and treatment techniques in medical diagnosis of spondylolisthesis, spinal stenosis, cancer or degen-
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accordance to pre-established principles, such as interrelation between erative osteomioarticular diseases of the upper limbs, or pregnancy at
structure and function, intrinsic self-regulation and homeostasis, and the time of the study were also excluded. Participants who had received
concept of body unity (Kuchera, 2007). some form of manipulative treatment in the last three months and/or
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Current evidence indicates that OMT is more effective than placebo who engages in physical activity on a regular basis were likewise ex-
treatment or no treatment for pain and function (Franke et al., 2015; cluded.
Hamilton et al., 2007; Mandara et al., 2010). A recent systematic
review (Franke et al., 2015) demonstrated clinically relevant effects 2.3. Initial assessment
of OMT for reducing pain in patients with NCNP. However, these stud-
ies have not investigated the effectiveness and impact of OMT combined The eligibility criteria data was collected during the initial assess-
with exercises on NCNP patients. ment after the participant had read and signed the Informed Consent
Therefore, the objective of this clinical trial was to assess the effec- Form and the protocol had been approved by the university's research
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tiveness of osteopathic manipulative treatment combined with stretch- ethics committee. Psychological factors are known to be highly linked
ing and strengthening exercises on the cervical region for conservative with neck pain (Blozik et al., 2009). Depressive mood and anxiety,
treatment of individuals with NCNP. were measured by the Hospital Anxiety and Depression Scale (HADS)
(Marcolino et al., 2007; Pais-Ribeiro et al., 2007; Zigmond and
2. Materials and methods Snaith, 1983). It consists of two subscales with seven items each. Pos-
sible subscale scores range from 0 to 21. According to the German Test
2.1. Study design Manual, patients with a depression score >8 were considered depres-
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sive, patients with an anxiety score >10 were considered anxious.
This study was a pragmatic single-blinded randomized controlled
trial conducted from June 2017 to December 2018. Pragmatic studies 2.4. Outcome measurements
are designed to evaluate the effectiveness of interventions in real-life
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practice conditions and to test interventions in the full spectrum of The outcomes of the participants were collected at baseline
everyday clinical settings in order to maximize clinical applicability (pre-treatment) and after 4 weeks of treatment (post-treatment). Pri-
(Harper et al., 2019; Patsopoulos, 2011; Treweek and Zwaren- mary outcomes were pain and disability and these were evaluated by the
stein, 2009). Numeric Pain Rate Scale (NPRS) and Neck Disability Index (NDI). Sec-
The study protocol was approved by the local human research ethics ondary outcomes were Pressure Pain Threshold (PPT), Range of Motion
committee and registered at ClinicalTrials.org under registration No. (ROM) for cervical spine rotation, Fear-Avoidance Beliefs Questionnaire
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NCT03085355. The general study design is presented in a flowchart (FABQ) and Pain-self efficacy. Each group followed the same measure-
(Fig. 1). This paper was reported according to the CONSORT statement ment protocol.
(Schulz et al., 2010).
After verifying eligibility, each participant was randomly assigned - NPRS: cervical pain was assessed using the 11-point Numeric Pain
to either the exercise group (EG) or the exercise group combined with Rating Scale (0 = no pain, 10 = worst possible pain) for the previous
osteopathic manipulative treatment (OMT/EG). The protocol for each week; The Minimum Clinically Important Change (MCIC) of the NPRS
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group took four weeks, with four exercise sessions for the EG and four has been reported as 1.3 points for patients with neck pain (Barry and
exercise sessions combined with osteopathic manipulative treatment for Jenner, 1995; Cleland et al., 2008). The question made in regards
the OMT/EG. to pain was “what was the worst pain you felt within the last week?“.
Prior to the study, an online software from RANDOM.ORG was used - NDI: The Neck Disability Index score was used for the disability assess-
to generate a randomization list, and 90 participants were allocated into ment. The NDI is widely used for assessing disability caused by neck
two treatments groups: EG or OMT/EG. These sequentially generated pain, and has high test-retest reliability (Vernon and Mior, 1991). It
numbers were placed in 90 sealed opaque envelopes, informing which is a validated 10-item questionnaire where each item is rated on a 0 to
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group each participant would belong. The envelope was only opened 5-point scale(Cook et al., 2006; Vernon and Mior, 1991), and has
after the participant had completed all the baseline assessments (Doig a report from 3.5 to 9.5 points represents a minimal clinically impor-
and Simpson, 2005). All the participants were told about the existence tant change MCIC (Cleland et al., 2008; Pereira, 2012; Pool et al.,
of the EG and OMT/EG groups. The therapists who performed the treat- 2007) (Stratford, 1999).
ments could not be blinded. The evaluators who carried out the assess- - PPT: Pressure Pain Threshold was measured using a handheld elec-
ments were blinded in relation to the group that each participant be- tronic pressure algometer (model DD-2000, Instrutherm®) presented a
longed. probe of 1.0 cm2 (base tip) which was calibrated before testing begin.
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t's head. The measurements were repeated three times, and the fi- - Pain-self efficacy: this outcome consists of 5 questions about the pa-
nal score was the arithmetic average of the three measurements. The tient's confidence in carrying out various normal activities despite the
CROM has good intratester and intertester reliability and validity (M. pain. The questionnaire has 5 questions about pain management by
A. Williams, McCarthy, Chorti, Cooke and Gates, 2010). the patient. Responses range from 10 percent sure to 100 percent sure
- FABQ was used to assess the patients' beliefs regarding the effect of (Salvetti and Pimenta, 2005).
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geting the deep neck muscles (Blanpied et al., 2017). The exercises Table 1
Comparison between baseline characteristics from patients with non-specific chronic neck
had low isometric resistance and consisted of three sets of 10 repetitions
pain in the exercise group (EG) and in the osteopathic manipulative treatment group
in supine and sitting positions. Participants were instructed to perform (OMT/EG).
the exercises at home 3 times a week in a way that did not cause pain.
OMT/Exercise Group: The exercise protocol of the OMT/EG was the OMT/EG Difference between
EG (n = 38) (n = 45) groups p
same as the one for the exercise group. Apart from the exercises, the
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participants in the OMT/EG also received full osteopathic treatments, Women (%) 84,2% 93,3% 9.1 >0.05
once a week over the course of four weeks, with each session lasting (n = 32) (n = 42)
50–60 min. Ten registered osteopaths performed all the treatments. At Age (years) 42.8 ± 9.8 40.2 ± 12.3 2.5 0.3
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Weight (kg) 70.4 ± 10.60 67.0 ± 11.4 3.4 0.1
each visit, participants received a full-body osteopathic examination in
Height (m) 1.65 ± 0.07 1.63 ± 0.07 0.02 0.5
accordance with osteopathic principles, which included clinical exams, NPRS 5.5 ± 1.6 5.7 ± 1.7 0.17 0.6
observation, screening tests, palpation and motion testing. The osteo- NDI 18.87 ± 6 18.87 ± 5.1 0 0.9
pathic manipulative treatment entailed: direct (high-velocity low-ampli- FABQ W 20.5 ± 11 20.0 ± 10 0.4 0.8
FABQ PA 9.8 ± 7.5 11.1 ± 7 1.2 0.4
tude; muscle energy; and myofascial release), indirect (functional tech-
HADS A > 65.8 ± 4 66.7 ± 4 0.9 0.9
niques and balanced ligamentous tension), visceral and cranial tech- 10 (%)
niques (Glossary of Osteopathic Terminology). The osteopaths were free HADS D > 8 28.9 ± 4 24.4 ± 4 4.5 0.8
to assess the participants and decide which techniques were best to use.
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(%)
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of significance of 0.05 (0.5%) was stipulated, statistical power of 80%, 3. Results
and 20% of losses could occur.
The statistical analysis was performed by a statistician who was In total, 90 individuals were assessed for eligibility criteria, from
blinded to the randomization, measurement and intervention protocols June 2017 to December 2018, and then randomly assigned to the ex-
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according to intention-to-treat principle. Statistical analyses were con- ercise (n = 45) and OMT/EG (n = 45) groups (Fig. 1). The subjects of
ducted using SPSS Statistics 20 for Windows (IBM, Armonk, NY, USA). the both groups showed similar baseline characteristics. There were no
Demographic data and initial assessment results were compared using statistically significant differences between-groups at baseline charac-
independent t-tests. The normality of the data was verified by visual in- teristics (gender, age, weight, height and body mass index, NPRS, NDI,
spection and the standard deviation size was also considered in relation FABQ, HADS) (p > 0.05; Table 1). No adverse events were reported
to the mean and also considered if the skewness and kurtosis analysis
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during study.
of the values of the pre- and post-treatment variables. Mean values and There was within-group difference in pain (p < 0.05) and disabil-
standard deviation were calculated for each study variable. Generalized ity (p < 0.05) (Table 2). In addition, patients of the OMT/EG showed
estimating equations model (GEE) complemented by the least significant an increase in cervical rotation range of motion to both sides (ROM;
difference (LSD) were used to evaluate the effects of treatment. This test p < 0.05; Table 3). This increase in the range of motion did not occur
considers the missing data allowing for intent-to-treat analysis. Effects in EG (p > 0.05; Table 3).
on time, group and time-by-group interaction were considered. Statisti- Osteopathic Manipulative Treatment combining with exercise led
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cal analysis was conducted with a 95% confidence interval, an α value to greater reductions in disability and pain compared with the EG.
of 5%, thus representing a value of p ≤ 0.05. OMT/EG showed lower NPRS (mean difference, −1,4; 95% CI -2,4 to
- 0,3; p = 0,007),
Table 2
Summary of primary outcomes results: Numeric Pain Rate Scale (NPRS), Pressure Pain Threshold (PPT) and neck disability index (NDI).
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NPRS OMT/ 5.7 ± 0.2 2.3 ± 0.2*# 3.4 ± 0.2 0.9 0.00 −1,4 ± 0,5 0.8 0,007
EG (2.9–3.9) (−2,4 to -
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0,3)
EG 5.5 ± 0.2 3.6 ± 0.4* 1.9 ± 0.3 0.9 0.00
(1.1–2.6)
PPT OMT/ 3.3 ± 0,4 2,8 ± 0,4 0.5 ± 0.3 _ 0.2 −0,5 ± 0,6 _ 0.4
EG (−0.3 to (−1,7 to
1.3) 0,7)
EG 2,9 ± 0,3 3,3 ± 0,4 −0.4 ± 0.2 _ 0.2
(−1.3 to
0.3)
NDI OMT/ 18.9 ± 6.2 11.2 ± 6.8*# 7.7 ± 0.8 0.5 0.00 −3,8 ± 1,5 0.2 0,01
EG (6.0–9.3) (−0,74
to −6,9)
EG 18.8 ± 8.0 15.0 ± 8.8* 3.8 ± 0.9 0.2 0.00
(1.9–5.7)
Data expressed as mean ± standard deviation (SD). Pre = baseline values; Post = values after 4 weeks treatment protocol; OMT/EG = osteopathic manipulative treatment group,
EG = Exercise group, PPT= Pressure Pain Threshold CI = confidence interval, *p < 0.05 vs pre-values; #p < 0.05 vs EG. Effect sizes were expressed as Cohen's d, and an effect size
greater than 0.8 was considered large, an effect size of approximately 0.5 was considered moderate, and an effect size of less than 0.2 was considered small.
S. Groisman et al. / Journal of Bodywork & Movement Therapies xxx (xxxx) 1–7 5
Table 3
Summary cervical range of motion (ROM), Fears Avoidance Believes Questionnaire (FABQ) and pain self-efficacy results.
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ROM left OMT/ 56.8 ± 2.2 67.4 ± 1.6*# 10.6 ± 1.5 0.9 0.0 6.9 ± 3.3 0.8 0,03
EG (13–7.4) (0,4 to
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13,4)
EG 56.4 ± 2.0 60.5 ± 2.8 4.1 ± 2.1 _ 0.6
(−8.2 to
0.1)
ROM right OMT/ 54.5 ± 2.2 65.1 ± 1.8*# 9.6 ± 1.5 0.9 0.0 8 ± 3.4 0.8 0.03
EG (12–6.4) (0.3–13.6)
EG 55.1 ± 1.8 57.1 ± 2.8 2.0 ± 1.8 _ 0.3
(−5.7 to
1.7)
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FABQ W OMT/ 20.0 ± 11 18.2 ± 12 1.8 ± 1.5 _ 0.2 −1.3 ± 3 _ 0.6
EG (−1.1 to (−7.2 to
4.9) 4.5)
EG 20.5 ± 10 16.8 ± 12 3.7 ± 1.6 _ 0.2
(−0.5 to
6.8)
FABQ FA OMT/ 11.1 ± 7 10.3 ± 7 0.7 ± 0.9 _ 0.4 1.8 ± 1.7 _ 0.2
EG (−1 to 2.5) (−5.2 to
1.6)
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EG 9.8 ± 7.5 8.5 ± 7 1.3 ± 1.3 _ 0.3
(−1.2
to3.9)
Pain-self efficacy OMT/ 352.6 ± 95 380.9 ± 79* −28.3 ± 12 0.1 0.0 −3,9 ± 18,7 _ 0,8
EG (−53 (−32,8 to
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to −3) 40,8)
EG 319.7 ± 100 377 ± 81* −57.2 ± 10 0.3 0.0
(−78
to −36)
Data expressed as mean ± standard deviation (SD). Pre = baseline values; Post = values after 4 weeks treatment protocol; OMT/EG = osteopathic manipulative treatment group,
EG = Exercise group, Threshold CI = confidence interval. FABQ W = Fears Avoidance Believes Questionnaire Work; FABQ FA - Fears Avoidance Believes Questionnaire physical active.
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*p < 0.05 vs pre-values; #p < 0.05 vs EG. Effect sizes were expressed as Cohen's d, and an effect size greater than 0.8 was considered large, an effect size of approximately 0.5 was
considered moderate, and an effect size of less than 0.2 was considered small.
NDI (mean difference, −3,8; 95% CI -0,74 to −6,9; p = 0,01) and higher erla et al., 2008; N. H. Williams et al., 2003). However, these stud-
cervical rotational range of motion values when compared to patients of ies compared osteopathic treatment with placebo treatment. Similarly,
the exercise group (p < 0.05; Tables 2 and 3). another randomized trial, which included participants with neck pain,
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There were no significant between-group differences at either 4 found that OMT improved quality of life compared with placebo treat-
weeks in Pain-self efficacy (mean difference, −3,9; 95% CI -32,8 to 40,8; ment (Schwerla et al., 2008). In contrast to those trials, the present
p = 0,8), PPT (mean difference, −0,5; 95% CI -1,7 to 0,7; p = 0,4) and study compared exercises on its own and OMT combined with exercises,
FABQ outcomes (p > 0.05) (Tables 2 and 3). and found that neck pain was significantly reduced in both groups.
When comparing the two groups, statistically significant difference
4. Discussion was noted for pain. The difference in pain between the groups was sig-
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nificant in the study. Moreover, the effect size for the NPRS score was
The main purpose of the present study was to assess the combina- larger in the OMT/exercise group (r = 0.50), demonstrating a 3-point
tion of OMT and strengthening and stretching exercises in subjects with reduction, which constitutes a clinically significant difference. This re-
non-specific chronic neck pain and disability. The results demonstrated sult suggests that people suffering from neck pain can have benefits from
that combining both treatments led to reduction of pain and improve- OMT.
ments of function disability. Multiple factors may have contributed to In a recent systematic review, it was suggested that OMT improves
the improvement in the functioning and pain levels in individuals with functionality. This coincides with the findings of the present study
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chronic neck pain after osteopathic manipulative treatment in combi- where improvement in functionality only occurred in the OMT/EG
nation with exercise, such as mechanical, neurophysiological, and psy- (Franke et al., 2015). The authors of this review suggested that future
chosocial effects (Hidalgo et al., 2017). studies should consider adding exercises to enhance OMT effectiveness
Several studies have shown that manual therapy combined with ex- (Franke et al., 2015). This was exactly the main goal of the present
ercises is more effective for patients with neck pain than manipulation study, i.e., to demonstrate that combining OMT with exercises can be
or exercises alone (Bronfort et al., 2001; Evans et al., 2002). As far highly effective.
as we know, this is the first study to investigate the effects of OMT com- The use of cervical exercises alone for chronic neck pain has been
bined with exercises on individuals with non-specific chronic neck pain. extensively demonstrated in the references cited in this study (Ce-
The findings showed a reduction of pain and an improvement in func- lenay et al., 2016; Rendant et al., 2011; Ylinen et al., 2003).
tion in both groups, what supports the use of combined OMT and ex- However, another trial suggested that there are benefits in combin-
ercises in achieving clinically important pain reduction and functional ing exercises and manual therapy for pain reduction, as opposed to
improve. manual therapy on its own (Martel et al., 2011). The present study
In previous clinical trials, patients with neck pain treated with OMT found that participants in the exercise group combined with OMT had
experienced a reduction in pain of at least 1.5 points (Mandara et al., less pain and disability and functioned better as com
2010; Schw
6 S. Groisman et al. / Journal of Bodywork & Movement Therapies xxx (xxxx) 1–7
pared to the group that only performed the exercises. OMT was adminis- Declaration of competing interest
tered in a pragmatic way in accordance with osteopathic principles. The
therapists treated all dysfunctions they considered as relevant during the None.
examinations. A pragmatic approach is a real-life situation model, and
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