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Lopez 2021

1) The study compared the effectiveness of dry needling (DN) or percutaneous needle electrolysis (PNE) combined with eccentric exercise (EE) versus EE with sham needling for treating patellar tendinopathy (PT). 2) 48 participants were randomized into three groups: DN+EE, PNE+EE, or sham needling+EE. All groups performed a home exercise program and received four treatment sessions over 8 weeks. 3) The study found that disability, pain, and quality of life improved significantly from baseline to post-treatment and follow-up in all groups, with no differences between groups. Structural changes in the tendon did not correlate with clinical improvements.

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0% found this document useful (0 votes)
61 views9 pages

Lopez 2021

1) The study compared the effectiveness of dry needling (DN) or percutaneous needle electrolysis (PNE) combined with eccentric exercise (EE) versus EE with sham needling for treating patellar tendinopathy (PT). 2) 48 participants were randomized into three groups: DN+EE, PNE+EE, or sham needling+EE. All groups performed a home exercise program and received four treatment sessions over 8 weeks. 3) The study found that disability, pain, and quality of life improved significantly from baseline to post-treatment and follow-up in all groups, with no differences between groups. Structural changes in the tendon did not correlate with clinical improvements.

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© © All Rights Reserved
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Archives of Physical Medicine and Rehabilitation

journal homepage: www.archives-pmr.org


Archives of Physical Medicine and Rehabilitation 2021;-:-------

ORIGINAL RESEARCH

A Comparative Study of Treatment Interventions for


Patellar Tendinopathy: A Randomized Controlled Trial
Marı́a Pilar López-Royo, PT, MSc,a,b José Rı́os-Dı́az, PT, PhD,c
Rita Marı́a Galán-Dı́az, PT, MSc,a Pablo Herrero, PT, PhD,b
Eva Marı́a Gómez-Trullén, MD, PhDb
From the aiPhysio Research Group, Universidad San Jorge, Villanueva de Gállego, Zaragoza, Spain; bUniversidad de Zaragoza, Faculty of Health
Sciences, Zaragoza, Spain; and cSan Juan De Dios Foundation, Health Sciences University Centre, Antonio de Nebrija University, Madrid, Spain.

Abstract
Objectives: To determine the additional effect of dry needling (DN) or percutaneous needle electrolysis (PNE) combined with eccentric exercise
(EE) and determine which is the most effective for patients with patellar tendinopathy (PT).
Design: Blinded, randomized controlled trial, with follow-up at 10 and 22 weeks.
Settings: Recruitment was performed in sport clubs. Diagnosis and intervention were conducted at San Jorge University.
Participants: Patients (NZ48) with PT with pain for at least 3 months between the ages of 18 and 45 years.
Interventions: Three interventions were carried out: DN and EE, PNE and EE, and EE with sham needle as the control group.
Main Outcome Measures: Disability was measured using the Victorian Institute of Sports Assessment Questionnaire, patellar tendon. Visual
analog scale was used to measure pain over time, the Short Form-36 was used to measure quality of life, and ultrasound was used to measure
structural abnormalities.
Results: A total of 48 participants (42 men, 6 women; average age, 32.46y; SD, 7.14y) were enrolled. The improvement in disability and pain in
each group between baseline and post-treatment and baseline and follow-up was significant (P.05), without differences among groups.
Conclusion: DN or PNE combined with an EE program has not shown to be more effective than a program of only EE to improve disability and
pain in patients with PT in the short (10wk) and medium (22wk) terms. Clinical improvements were not associated with structural changes in the
tendon.
Archives of Physical Medicine and Rehabilitation 2021;-:-------
ª 2021 by the American Congress of Rehabilitation Medicine

Patellar tendinopathy (PT), also known as jumper’s knee, is a International Consensus (ICON) 2019 Statement,1,5 structural
persistent patellar tendon pain at the inferior pole of the patella changes were not identified as a core domain for PT diagnosis,
associated with loss of function related to mechanical loading.1 color Doppler ultrasound (CD-US) images appear to be useful for
The overall prevalence in nonelite players from different sports obtaining quantitative information. Furthermore, quantitative
is 8.5%,2 although this percentage increases in elite sports.3 analysis of echovariation has proven to be a useful tool for eval-
Among elite volleyball and basketball players, the prevalence of uation of musculoskeletal pathologies.6-8
jumper’s knee has been reported to be 45% and 32%, respec- Eccentric exercise (EE) is considered the criterion standard for
tively.3 In addition, PT is almost twice as common among male conservative management and is therefore accepted as the first-
nonelite athletes compared with female athletes.2 Moreover, it can line approach for managing PT.9 Over the years, EE has been
negatively affect quality of life (QOL).4 shown to be effective in the treatment of various tendino-
The diagnosis is based on pain over the tendon with loading pathies,10-12 including PT, and in this last one there was greater
tasks and a loss of function. Although according to the clinical improvement when EE was performed on a declined
surface.13 In the past years, some randomized controlled trials
(RCTs) have investigated different types of exercise, such as
heavy slow resistance or isometric training, for the treatment of
Clinical Trial Register No.: NCT02498795.
Disclosures: none.
PT,14,15 showing that both are effective at improving function and

0003-9993/21/$36 - see front matter ª 2021 by the American Congress of Rehabilitation Medicine
https://doi.org/10.1016/j.apmr.2021.01.073
2 M.P. López-Royo et al

decreasing pain in the short and long terms. In addition, exercise injection in the patellar tendon within the previous 3 months; (4)
has been demonstrated to be superior than other conventional contraindications for needling (ie, fear of needles, allergy to
treatments, such as iontophoresis, ultrasound (US), Cyriax treat- needle material); (5) anti-inflammatory, analgesic or antibiotic
ment, and others.16,17 medications within the previous 48 hours; and (6) any other
Other options have been proposed for health care practitioners concomitant treatment for PT.
that may be helpful for tendinopathy, such as dry needling
(DN)18,19 and electrotherapeutic invasive modalities (eg, percu- Intervention
taneous needle electrolysis [PNE]).20-23 Recently, research has
focused on regenerative therapies because some of these tech- In the first session, all participants were instructed on how to
niques appear to achieve a faster improvement of the symptoms perform 3 sets of 15 single-leg squat repetitions on a decline board
and a possible regeneration of the injured tendon.18,21,24 However, twice a day, according to Young’s protocols,13 increasing the
evidence-based regenerative therapies are limited, and there is no speed if participants did not have pain. Following the criteria
agreement to date regarding which of these therapies is the most found in studies conducted on the Achilles’ tendon,27 to achieve
effective.25 Therefore, the aim of this study was to determine pain monitoring, the patients were informed that exercise was
whether the addition of either DN or PNE to EE was superior to allowed to reach 5 in a numerical pain rating scale. It was not
sham needling and EE in patients with PT. recorded whether patients were previously familiar with EE. The
physiotherapist explained how to do the exercises to all partici-
Methods pants to ensure they knew how to do them at home.
For the needle intervention, the participants were placed in a
Study design supine position with a pillow under the knee (approximately 20
degrees of knee flexion). The area was cleaned with an antiseptic
A RCT with blinded assessors and participants was conducted to solution (70% propan-2-ola), and a US probe cover was used
determine whether the addition of either DN or PNE to EE was during the intervention. Each group received 4 sessions distributed
superior to sham needling and EE in patients with PT. every 2 weeks over 8 weeks of treatment. No participant had
received any previous needling treatment in the tendon.
Ethics
DN intervention combined with EE and PNE intervention
This RCT follows the standards of the Declaration of Helsinki and combined with EE
Good Clinical Practice and was approved by the Aragón Ethics Specific DN needles were used during the needling treatments
Committee (No. PI15/0017). The study was developed following (Agupuntb). Considering the thickness of the tendon and the
the design of a previously published protocol.26 approach, 0.2525 mm needles were used. The procedure was
US-guided to ensure the specificity of application on the injured
Participants area and to guarantee that the procedure was safe for the patient.
Each session consisted of 3 needle insertions lasting 3 seconds
each. In the PNE intervention combined with EE group applica-
Inclusion criteria
tions, an intensity of 3 mA galvanic current was used during the 3
Participants eligible for inclusion in this study met the following
seconds that the procedure lasted.
criteria: (1) anterior knee pain located on the inferior pole of the
patella for at least 3 months while practicing sport; (2) age be-
Control group
tween 18 and 45 years old; (3) practicing any kind of sports at
A sham needle was placed on the treatment zone, simulating the
least 3 times a week; and (4) score less than 80 on the Victorian
same procedure undergone by the participants enrolled in the
Institute of Sport Assessment-Patellar questionnaire (VISA-p).
other groups. Apart from the needle blinding with a sham needle,
the physiotherapist performing the interventions placed high
Exclusion criteria
importance on the entire intervention experience, as cognitive
Exclusion criteria for the study were: (1) knee surgery within the
influences that extend beyond mimicking of tactile sensations are
previous 6 months; (2) chronic joint diseases; (3) corticosteroid
recommended to create a believable simulation.28 The needle was
placed in a specific holder and was manipulated during the
List of abbreviations: intervention to simulate a real treatment.
CD-US color Doppler ultrasound
CONSORT Consolidated Standards of Reporting Trials Outcomes
DN dry needling
EE eccentric exercise
ICON International Consensus Baseline data
PNE percutaneous needle electrolysis Baseline data included sex; age; height; weight; body mass index;
PRP plasm-rich platelet affected side; level of physical activity performance; duration of
PT patellar tendinopathy symptoms; medication; previous rehabilitation treatments; and
QOL quality of life any previous corticosteroid, plasm-rich platelet (PRP), or drug
RCT randomized controlled trial injections. An assessor blind to treatment evaluated all participants
SF-36 Short Form-36 Health Survey at baseline, as well as 10 weeks and 22 weeks after baseline.
US ultrasound
VAS visual analog scale
Primary outcome measure
VISA-p Victorian Institute of Sports Assessment
Disability was measured using the Spanish version of VISA-p.29
Questionnaire, patellar tendon
This questionnaire was designed to evaluate the severity of

www.archives-pmr.org
Treatment interventions for patellar tendinopathy 3

symptoms, knee function, and ability to play sports in athletes Sample size
with PT.30 The maximum VISA-p score for an asymptomatic
athlete is 100 points. The VISA-p questionnaire has high reli- A calculation of statistical power was made before the study.
ability (intraclass correlation coefficient, 0.994; 95% confidence Accepting an alpha risk of 0.05 and a beta risk of 0.80 in a
interval, 0.992-0.996).29 bilateral contrast, 16 participants were needed in every treatment
group to detect a difference equal or superior to 15 points on the
Secondary outcome measures VISA-p and assuming a standard deviation of 15 points.35 The
The visual analog scale (VAS)31 was used to measure the level of estimated loss to follow-up rate was 20%. For this reason, 3 more
pain over time. Patients were asked about the mean and maximum participants were necessary in each of the groups, resulting in a
pain that they had in the 24 hours prior to the assessment. The total of 19 participants per group for this study.
Short Form-36 Health Survey (SF-36) was used to assess QOL.32
Ultrasonographic measures were made to assess tendon Recruitment
structure and was performed by the same person. US equipment Recruitment of subjects for the trial was conducted by means of
(Logic S7 Expertc) with a linear probe (MLG-15 5-10 MHz) was informative campaigns targeted at different sports clubs and
used. The ultrasonographic assessment protocol was carried out federations.
according to the Musculoskeletal US Technical Guidelines, as
defined by the European Society of Musculoskeletal Radiology.33 Allocation
The presence of degenerative signs compatible with the medical
diagnosis of PT (thickness of the tendon, hypoechoic areas, ir- Participants were randomly assigned by a researcher to the control
regularities affecting the cortical bone, and calcifications) that group, DN intervention combined with EE group, or PNE inter-
could be relevant for the selection of the target area were assessed. vention combined with EE group with a 1:1:1 allocation using an
In addition, CD-US assessment was conducted to detect opaque envelope, with a block size of 15 participants.
neovascularization.
The image analysis was performed by a different researcher
Blinding
blinded to the group with 20 years of experience in image analysis
with high levels of reliability.34 ImageJ 1.52p softwared was used Assessments were made by an assessor blinded to treatment
to make a quantitative analysis of the CD-US image for the allocation. In order to blind patients, all interventions were made
quantification of Doppler signals (fig 1). Echointensity and with the US and PNE device connected to simulate the same
echovariation were determined on a region of analysis obtained in intervention in all groups. This procedure was designed with the
the longitudinal section. Three regions of analysis were selected, intention to blind the participants, but as this cannot guarantee
and the mean was used for statistical analysis. complete blinding, a questionnaire was administered at the end of

Fig 1 Doppler quantification. Doppler ultrasound quantification by image analysis. The image was segmented, and the number and size of
Doppler signals were determined.

www.archives-pmr.org
4 M.P. López-Royo et al

the study. Patients were asked by e-mail ‘‘Do you know which that positive values indicate an increase and negative values
treatment you received?’’ The possible answers were: “No indicate a decrease in the respective parameter. Cohen’s kappa
needling treatment,” “Needling treatment,” or “I don’t know.” coefficient was used to compute the agreement of group allocation
between real allocation and the subject’s guess. The significance
level set for all the analyses was a P value of .05 or less.
Data management and statistical analysis
The statistical analysis was performed with IBM SPSS Statistics
(version 19)e and R version 3.6.1 jamovi package.f The method for
analysis was intention to treat. Variables were described in number
Results
(percentage) and average (standard deviation) or median (inter- A total of 72 patients were assessed for eligibility, 50 of
quartile range), attending to their distribution. Baseline features whom were recruited. Recruitment began in January 2019 and
between groups were compared using 1-way ANOVA for was completed in December 2019. Two participants dropped
continuous data and the chi-squared test for categorical data. out of the study before starting the intervention. Finally, 48
Outcomes were analyzed using mixed linear models considering nonelite players (42 men, 6 women; average age, 32.46y; SD,
participants as a random effects and group of treatment as a fixed 7.14y) were randomized into 3 groups. The flow chart of the
factor. Pairwise Dunn-Bonferroni comparisons were performed as trial is shown in figure 2. No significant differences were
post hoc analyses. Finally, for the determination of effect size of found between the groups at baseline in terms of socio-
the group-by-time interaction, omega-squared (u2) was used. demographic, clinical, and ultrasonographic variables
Intragroup effect size was determined by Hedges’ h, with 0.2 (tables 1 and 2), so none of them were introduced as a co-
considered a small effect size, 0.5 representing a medium effect variate in the linear model.
size, and 0.8 representing a large effect size. In addition, the Eighteen patients did not complete the blinded questionnaire
percentage change from the baseline was calculated for clearer after the last session, and 2 patients chose “Don’t know.” There-
interpretation (Change% Z [baseline-data/baseline]  100), so fore, data from 28 patients were used to calculate Cohen’s kappa

Enrollment Assessed for eligibility (n=72)

Excluded (n=22)
Š Not meeting inclusion criteria (n=17)
Š Declined to participate (n=5)

Randomized (n=50)

Allocation

Allocated to DN (n=16) Allocated to PNE (n=17) Allocated to Control (n=17)


-Received allocated intervention (n=16) -Received allocated intervention (n=16) -Received allocated intervention (n=16)
-Did not receive allocated intervention: -Did not receive allocated intervention:
(n=1; no tendon pathology on US) (n=1; no tendon pathology on US)

Follow-Up

Lost to follow-up (n=0) Lost to follow-up (n=0) Lost to follow-up (n=0)

Discontinued intervention (n=0) Discontinued intervention (n=0) Discontinued intervention (n=0)

Analysis

Analysed (n=16) Analysed (n=16) Analysed (n=16)

Fig 2 Consolidated Standards of Reporting Trials (CONSORT) flow diagram.

www.archives-pmr.org
Treatment interventions for patellar tendinopathy 5

Table 1 Baseline of demographic and clinical data of the 3 groups


Sociodemographic Data DN-G (nZ16) PNE-G (nZ16) CG (nZ16) P Value
Men, n (%) 13 (81) 14 (88) 15 (94) .57
Age, y 33.2 (7.97); 19-45.8 31.1 (7.33); 19.3-41.2 32.7 (6.1); 20.6-40.2 .68
Weight, kg 74.5 (11.62); 59.4-101 80.6 (17.39); 42.8-115 78.6 (9.77); 55.4-94.2 .43
Height, m 1.76 (0.092); 1.61-1.91 1.77 (0.107); 1.55-1.98 1.78 (0.059); 1.6-1.86 .82
BMI, kg/m2 84.4 (10.37); 68.6-105.8 90.3 (15.74); 55.2-124.3 88.1 (9.61); 69.3-103.4 .82
Sport, times/wk 5.2 (1.42); 3-7 4.4 (1.15); 3-7 5.3 (1.24); 3-7 .39
Time from symptoms, mo 19 (28.4); 3-120 16.9 (10.3); 4-36 18.4 (16.3); 5-60 .95
Previous treatment, n (%) 12 (75) 13 (81) 11 (69) .72
Mean VAS 3.8 (1.98); 0-7 4.5 (1.85); 2-7 4.3 (2.11); 1-8 .57
Maximum VAS 6.4 (2.51); 2-10 7.2 (2.14); 3-10 6.5 (2.32); 2-10 .65
VISA-p 57.2 (14.14); 29-79 48.9 (14.56); 30-75 55.5 (10.44); 42-79 .16
SF-36 0.8 (0.12); 0.5-0.9 0.7 (0.13); 0.4-0.9 0.8 (0.09); 0.5-0.9 .21
NOTE. Data are presented as mean (SD); range. P value for chi-squared (sex), and analysis of variance for 1 factor.
Abbreviations: CG, control group; DN-G, dry needling intervention combined with eccentric exercise group; PNE-G, percutaneous needle electrolysis
intervention combined with eccentric exercise group.

coefficient. Cohen’s kappa coefficient was 0.14 (95% confidence (PZ.01). At 22 weeks, there were significant improvements for all
interval, 0-0.30). groups (P.05).

Maximum VAS
Clinical outcomes There were no significant differences for the maximum VAS score
between groups. Regarding differences within groups, there were
Disability (VISA-p) significant improvements in all groups at both 10 and 22
There were no significant differences for the VISA-p score among weeks (P.05).
the 3 groups. However, a significant effect was found in all groups
at both the 10- and 22-week follow-up evaluations (P˂.01). These QOL (SF-36)
results are shown in table 3. A total of 66.67% of the patients There were no significant differences between groups for the SF-
obtained a clinically relevant improvement (>15 points in VISA- 36 score. There were only significant improvements of QOL in the
p) after receiving their treatment, achieved by almost 73% of PNE intervention combined with EE group (PZ.01) at 10 weeks,
patients in the medium term. which was not maintained at 22 weeks follow-up.
All of the patients began the trial with less than 80 points in the
VISA-p. After 8 weeks, 39.6% of the patients reached a score Tendon structure (ultrasonography)
higher than 80 points, which is considered normal for individuals At baseline, the mean thickness of the patellar tendon of all the
without this pathology and is considered as good function. This patients was 0.65 cm, improving over time to 0.61 at the end of the
percentage increased to 54.17% at the medium term. study. Furthermore, 43.75% of the patients presented neo-
vascularization, decreasing to 31.25% at the end of the treatment.
Pain over time (VAS) However, there were no statistically significant changes in these
There were no significant differences between groups for mean parameters over time within groups. Also, there were no signifi-
VAS score. Regarding differences within the groups, there were cant differences between groups in thickness, number of vessels,
significant improvements at 10 weeks only for the PNE inter- echointensity, echovariation, total area of vessels, and mean area
vention combined with EE group (PZ.02) and the control group or vessel (table 4).

Table 2 Baseline of ultrasonographic parameters of the 3 groups


Ultrasonographic Parameter DN-G (nZ16) PNE-G (nZ16) CG (nZ16) P Value
Thickness, cm 0.67 (0.15); 0.46-0.88 0.59 (0.141); 0.41-0.83 0.66 (0.172); 0.44-0.97 .519
Number of neovessels 2.6 (3.27); 0-11 1.3 (1.91); 0-5 1.3 (1.95); 0-7 .660
Total neovessels area, cm2 1.1 (1.24); 0-3.8 0.9 (1.63); 0-5.1 0.7 (0.97); 0-2.8 .210
Mean area/vessels, cm2 0.31 (0.464); 0-1.81 0.29 (0.409); 0-1.27 0.29 (0.369); 0-0.98 .971
Echointensity, 0-255 53.5 (17.52); 27.8-84.7 60 (12.52); 40-73.5 60.4 (19.23); 23.5-94.1 .435
Echovariation 42.8 (13.71); 25.3-74.7 40 (9.8); 26.2-58.1 40.3 (12.54); 25-70.5 .744
NOTE. Data are presented as mean (SD); range. P value for chi-squared (sex), and analysis of variance for 1 factor.
Abbreviations: CG, control group; DN-G, dry needling intervention combined with eccentric exercise group; PNE-G, percutaneous needle electrolysis
intervention combined with eccentric exercise group.

www.archives-pmr.org
6 M.P. López-Royo et al

Discusssion

Abbreviations: CI, confidence interval; CG, control group; DN-G, dry needling intervention combined with eccentric exercise group; MD, mean difference; PNE-G, percutaneous needle electrolysis intervention
Hedges’ g P Value Change, %

NOTE. P value significative for <.05 with Dunn-Bonferroni correction. % change indicates percentage of change with respect to baseline: (baseline-data)/baseline*100, so that positive values indicate an
The results of this blind RCT indicate that treatment with DN and

e76
e56
e56
e68
e59
e51
PNE combined with an EE protocol have not been shown to be
37
50
43

2
6
7
more effective than an exercise program to improve disability and
pain in patients with PT in the short and medium terms and that
<.01
<.01
<.01
<.01
<.01
<.01
<.01
<.01
<.01
.99
.99
.99
any of the treatments achieved structural changes.
In recent years, there have been reports of a beneficial effect of
DN19,36-38 and PNE20,21,39-42 in the treatment of tendinopathy, but
the results of comparative studies have not been reported. In the
1.00
1.21
1.41
1.40
1.61
0.78
1.24
1.66
0.76
0.07
0.17
0.06
case of PNE, there are only 2 RCTs that have evaluated PNE vs
(e4.25 to e1.57)
(e3.87 to e1.19)
(e3.78 to e1.02)
(e6.46 to e2.35)
(e6.28 to e2.16)
(e5.42 to e1.18)
other interventions. One study evaluated the effectiveness for

(e0.12 to 0.15)
(e0.09 to 0.18)
(e0.12 to 0.14)
adductor longus enthesopathy comparing PNE with a control
(12.94-35.93)
(12.63-35.62)
(9.51-32.49)

group performing only the exercise program,43 whereas the other


22 wk vs Baseline

analyzed the effect of PNE in plantar fasciosis compared with


Hedges’ g P Value Change, % MD (95% CI)

corticosteroid infiltration.41 These studies had similar sample and


outcome measurements to ours, finding that PNE was effective to
e2.4

e3.3
21

e2.91
e2.53

e4.41
e4.22

0.01
24.44
24.13

0.04
0.01

improve pain and function but without differences be-


tween groups.
Regarding PNE in PT, only some observational descriptive
studies have been published. Our study showed that all groups
improved, which was similar to other studies using the VISA-
e34
e39
e46
e36
e37
e38

p.20,21 In addition, QOL showed a significant improvement at 10


29
34
37

10
6

weeks for the PNE intervention combined with EE group only in


<.01
<.01
<.01

the short term, which is similar to a study performed by Moreno


.12
.02
.01
.03
.01
.02
.18
.01
.99

et al,43 which showed a trend in favor of the PNE intervention


combined with EE group at the end of the treatment and 8 and 16
weeks later. However, this information should be treated with
1.08
1.32
1.03
0.50
0.72
0.64
0.58
0.95
0.62
0.43
0.58
0.38

some caution because it was an isolated event. Only 2 studies have


compared DN with other techniques, such as PRP19 and autolo-
(e3.56 to e0.38)
(e4.47 to e0.22)
(e4.78 to e0.53)
(e4.66 to e0.27)

gous blood,44 both combined with exercise protocols in all groups.


(e3.29 to -0.21)
(e2.85 to 0.23)

(e0.01 to 0.11)

(e0.04 to 0.08)

However, none of them has been carried out with a control group
(7.45-25.92)
(7.58-26.05)
(9.58-28.05)

(0.01-0.14)
10 wk vs Baseline

to analyze whether invasive techniques may have an additional


Comparisons of change in clinical variables over time for each treatment group

effect compared with an exercise protocol alone. One of them19


MD (95% CI)

suggested that, at 26 weeks of follow-up, DN improved func-


tionality and pain, with better results than PRP. This suggests that
16.69
16.81
18.81
e1.31
e1.75
e1.97
e2.34
e2.66
e2.47
0.05
0.07
0.02

there is no need to use PRP if minimally invasive techniques or


exercise program can achieve better results in the short term.
In our study, we also analyzed structural changes. We found
(66.2-90.1)
(62.1-84.5)
(69.7-88.5)

(0.66-0.87)
(0.65-0.89)
(0.82-0.91)
Mean (95% CI)

(0.3-1.5)
(0.8-3.2)
(0.5-3.2)
(1.1-2.9)
(1.4-4.4)

that, despite the clinical improvements in all groups, there were no


(1.3-5)
Post 22 wk,

structural changes, at least at 3 months of follow-up. This appears


increase and negative values a decrease in the respective parameter.

to agree with the current evidence supporting that there can be


clinical changes despite not having structural improvements.1,45-52
78.2
73.3
79.1

0.77
0.77
0.86
0.9

1.9

2.9
3.2

In addition, we also measured neovascularization, as some studies


have suggested it is related to pain.53-55 More studies are neces-
DN-G 57.2 (14.14) 73.9 (63.9-83.8)
PNE-G 48.9 (14.56) 65.7 (56.6-74.8)

0.8 (0.76-0.84)
0.8 (0.77-0.83)
0.8 (0.09) 0.83 (0.77-0.89)
Mean (95% CI)

55.5 (10.44) 75.9 (66-85.8)


2.5 (1.1-3.9)
2.8 (1.8-3.7)
2.3 (1.1-3.5)
4.1 (2.3-5.8)
4.5 (3.2-5.8)
4 (2.4-5.6)

sary to clarify the true cause of pain and the existence or not of a
Post 10 wk,

relationship between pain and tendon structure.


One of the biggest biases that we can usually find in clinical
trials with needles is the true blinding of the patients. A systematic
review reported that patient blinding was unsuccessful in 33% of
combined with eccentric exercise group.

trials.28 Evidence shows that inadequate blinding leads to exag-


3.8 (1.98)
PNE-G 4.5 (1.85)
4.3 (2.11)
6.4 (2.51)
PNE-G 7.2 (2.14)
6.5 (2.32)
0.8 (0.12)
PNE-G 0.7 (0.13)
Groups Mean (SD)

gerated outcomes in clinical trials.56,57 In addition, therapist be-


Baseline,

haviors, expectations about treatment protocols, visual aspects of


the sham, and clinical assessments could be important features of
effective shams.58 There is still no agreement on the best method
DN-G

Maximum VAS DN-G

DN-G

of blinding for this type of intervention, but in our study, we found


CG

CG

CG

CG

that results obtained in the control and the DN group were not
biased as participants had a good blinding and did not know what
intervention was being received. However, all the participants in
Mean VAS
Variable
Table 3

the PNE group guessed the intervention to which they were


VISA-P

SF-36

allocated. This insufficient blinding in the PNE group could have


resulted in participants in this group improving more as they were

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Treatment interventions for patellar tendinopathy


Table 4 Comparisons of change in ultrasonographic variables over time for each treatment group
Baseline, Post 10 wk, Post 22 wk, 10 wk vs Baseline 22 wk vs Baseline
Variable Group Mean (SD) Mean (95% CI) Mean (95% CI) MD (95% CI) Hedge’s g P Value Change, % MD (95% CI) Hedge’s g P Value Change, %
Thickness, cm DN-G 0.67 (0.15) 0.68 (0.59-0.77) 0.62 (0.55-0.7) 0.01 (e0.06 to 0.08) 0.11 .99 1 e0.05 (e0.13 to 0.03) 0.59 .33 e7
PNE- 0.59 (0.14) 0.6 (0.5-0.7) 0.59 (0.5-0.69) 0.02 (e0.06 to 0.09) 0.04 .99 3 0.01 (e0.08 to 0.09) 0.03 >.99 1
G
CG 0.66 (0.17) 0.65 (0.56-0.74) 0.61 (0.53-0.7) e0.01 (e0.07 to 0.06) 0.07 .99 e1 e0.04 (e0.12 to 0.03) 0.30 .46 e7
Echointensity, 0- DN-G 53.5 (17.52) 50.8 (44.7-56.9) 54.9 (46.7-63.2) e2.66 (e7.98 to 2.66) 0.59 .66 e5 1.48 (e6.2 to 9.17) 0.10 .99 3
255 PNE- 60 (12.52) 58.8 (52.2-65.4) 52.7 (45.4-60) e1.18 (e7.33 to 4.96) 0.17 .99 e2 e7.28 (e16.16 to 1.59) 0.56 .14 e12
G
CG 60.4 (19.23) 56.4 (46.1-66.6) 57.4 (48.3-66.4) e4.05 (e9.37 to 1.28) 0.42 .19 e7 e3.02 (e10.7 to 4.67) 0.23 .99 e5
Echovariation DN-G 42.8 (13.71) 42.7 (37.8-47.5) 41.2 (34.4-47.9) e0.11 (e5.93 to 5.7) 0.01 .99 0 e1.62 (e10.68 to 7.44) 0.08 .99 e4
PNE- 40 (9.8) 36.2 (31.6-40.8) 42.2 (35.2-49.1) e3.8 (e10.52 to 2.91) 0.27 .49 e10 2.19 (e8.28 to 12.65) 0.15 .99 5
G
CG 40.3 (12.54) 39.8 (33.2-46.4) 40.8 (34-47.6) e0.47 (e6.28 to 5.35) 0.07 .99 e1 0.53 (e8.53 to 9.59) 0.04 .99 1
Number of DN-G 2.6 (3.27) 3.7 (1-6.4) 2.2 (0.4-3.9) 1.13 (e0.65 to 2.9) 0.25 .36 44 e0.38 (e2.15 to 1.4) 0.11 .99 e15
vessels PNE- 1.3 (1.91) 1.3 (e0.4 to 2.9) 1.5 (e0.7 to 3.7) 0 (e2.05 to 2.05) 0.06 .99 0 0.25 (e1.8 to 2.3) 0.08 .99 20
G
CG 1.3 (1.95) 0.38 (e0.05 to 0.8) 1.1 (e0.2 to 2.4) e0.88 (e2.65 to 0.9) 0.55 .68 e70 e0.13 (e1.9 to 1.65) 0.05 .99 e10
Total neovessels DN-G 1.1 (1.24) 1.4 (0.2-2.6) 0.9 (0.1-1.7) 0.31 (e0.55 to 1.18) 0.11 .99 29 e0.14 (e1.06 to 0.77) 0.11 .99 e13
area, cm2 PNE- 0.9 (1.63) 0.38 (e0.09 to 0.86) 0.88 (e0.24 to 2.01) e0.56 (e1.56 to 0.43) 0.38 .5 e59 e0.06 (e1.11 to 0.99) 0.03 .99 e6
G
CG 0.7 (0.97) 0.22 (e0.07 to 0.52) 0.54 (e0.03 to 1.11) e0.49 (e1.35 to 0.37) 0.71 .49 e69 e0.17 (e1.08 to 0.74) 0.13 .99 e24
Mean area/ DN-G 0.31 (0.46) 0.22 (0.07-0.36) 0.21 (0.06-0.35) e0.09 (e0.31 to 0.13) 0.25 .91 e30 e0.1 (e0.39 to 0.18) 0.23 .99 e33
vessels, cm2 PNE- 0.29 (0.41) 0.11 (e0.06 to 0.28) 0.22 (e0.03 to 0.47) e0.18 (e0.43 to 0.07) 0.46 .230 e63 e0.07 (e0.4 to 0.26) 0.12 .99 e24
G
CG 0.29 (0.37) 0.11 (e0.04 to 0.26) 0.18 (0-0.36) e0.18 (e0.4 to 0.04) 0.53 .147 e62 e0.49 (e1.35 to 0.37) 0.22 .99 e38
NOTE. P value significative for <.05 with Dunn-Bonferroni correction. % change indicates percentage of change with respect to baseline: (baseline-data)/baseline*100, so that positive values indicate an
increase and negative values a decrease in the respective parameter.
Abbreviations: CI, confidence interval; CG, control group; DN-G, dry needling intervention combined with eccentric exercise group; MD, mean difference; PNE-G, percutaneous needle electrolysis intervention
combined with eccentric exercise group.

7
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