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C OPYRIGHT Ó 2021 BY T HE J OURNAL OF B ONE AND J OINT S URGERY, I NCORPORATED

Shockwave Therapy Plus Eccentric Exercises

Versus Isolated Eccentric Exercises for Achilles
Insertional Tendinopathy
A Double-Blinded Randomized Clinical Trial

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Nacime Salomão Barbachan Mansur, MD, PhD, Fabio Teruo Matsunaga, MD, PhD, Oreste Lemos Carrazzone, MD, PhD,
Bruno Schiefer dos Santos, MD, Carlos Gilberto Nunes, Bruno Takeshi Aoyama, Paulo Roberto Dias dos Santos, MD, PhD,
Flávio Faloppa, MD, PhD, and Marcel Jun Sugawara Tamaoki, MD, PhD

Investigation performed at the Departamento de Ortopedia e Traumatologia, Escola Paulista de Medicina-Universidade Federal de São Paulo,

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São Paulo, Brazil

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Background: There remains a lack of consensus regarding the treatment of Achilles insertional tendinopathy. The
condition is typically treated with eccentric exercises despite the absence of satisfactory and sustained results.
Shockwave therapy was presented as an alternative, but there is a paucity of literature, with good outcomes, supporting
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its use. The purpose of the present single-center, double-blinded, placebo-controlled, randomized trial was to determine if
the use of shockwave therapy in combination with eccentric exercises improves pain and function in patients with Achilles
insertional tendinopathy.
Methods: A total of 119 patients with Achilles insertional tendinopathy were evaluated and enrolled in the study from
February 2017 to February 2019. Patients were allocated to 1 of 2 treatment groups, eccentric exercises with extra-
corporeal shockwave therapy (SWT group) and eccentric exercises with sham shockwave therapy (control group). Three
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sessions of radial shockwaves (or sham treatment) were performed every 2 weeks and eccentric exercises were
undertaken for 3 months. The primary outcome was the Victorian Institute of Sport Assessment-Achilles questionnaire
(VISA-A) at 24 weeks. Secondary outcomes included the visual analogue scale, algometry, the Foot and Ankle Outcome
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Score, and the 12-Item Short Form Health Survey.

Results: Both groups showed significant improvement during the study period; however, there were no between-group
differences in any of the outcomes (all p >0.05). At the 24-week evaluation, the SWT group exhibited a mean VISA-A of
63.2 (95% confidence interval, 8.0) compared with 62.3 (95% confidence interval, 6.9) in the control group (p = 0.876).
There was a higher rate of failure (38.3%) but a lower rate of recurrence (17.0%) in the SWT group compared with the
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control group (11.5% and 34.6%, respectively; p = 0.002 and p = 0.047). There were no complications reported for either
group.
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Conclusions: Extracorporeal shockwave therapy does not potentiate the effects of eccentric strengthening in the
management of Achilles insertional tendinopathy.
Level of Evidence: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.
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chilles tendinopathy is characterized by intratendinous
degeneration consequent to an erratic healing response
for microinjuries to the tissue1. The insertional ten-
dinopathy occurs from the tendon attachment onto the cal-
caneal tuberosity to 2 cm proximally and affects 5% to 18% of
adults, with a 50% lifetime probability among runners2.
Diagnosis is established through a combination of patient
reports of aching and/or pain, volume increase (occasionally

Disclosure: The authors indicated that no external funding was received for any aspect of this work. The Disclosure of Potential Conflicts of Interest
forms are provided with the online version of the article (http://links.lww.com/JBJS/G513).

Data Share: A data-sharing statement is provided with the online version of the article (http://links.lww.com/XXXXXXX).

J Bone Joint Surg Am. 2021;00:1-8 d http://dx.doi.org/10.2106/JBJS.20.01826

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with local hyperemia), and pain when palpating the insertional
region3. A traction enthesophyte (i.e., upper spur), a Haglund
deformity (i.e., pump bump), and bursitis are commonly found
along the tendinopathy and may illustrate the disease presentation4.
Treatment is initially nonoperative and based on an
eccentric strengthening program. However, despite reasonable
clinical results (60% to 82%) observed for noninsertional
Achilles tendinopathy, outcomes were not as robust for Achilles
insertional tendinopathy (AIT), even when the eccentric pro-
tocol modification, suppressing the loading in dorsiflexion
(“negative” phase), was suggested5,6. Other treatment modali-
ties had reported success rates ranging from 32% to 67% and
therefore cannot be recommended over the use of nonopera-
tive treatment with eccentric exercises7,8. Extracorporeal shockwave
therapy (SWT) has been proposed for the treatment of AIT, espe-
cially in cases in which nonoperative care has failed9,10. SWT is
thought to induce tissue regeneration by promoting neovasculari-
zation, stimulating the signaling and migration of mesenchymal cells
through a molecular pathway that is not yet fully understood11-13.
Notwithstanding the favorable results associated with the
use of SWT for AIT, there is still a paucity of high-quality
evidence for this treatment method14-16. To our knowledge, only
4 clinical trials have been published, although each has
reported better results for SWT compared with placebo, tra-
ditional physiotherapies, or eccentric exercises alone17-20. Sev-
eral systematic reviews have highlighted the methodological
flaws of the studies, from small samples to minor effect
sizes21-23. Within this context, some authors have recommended
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SWT for AIT after eccentric exercise alone has failed but before
surgical treatment has been indicated1,24.
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Mixed results and unreliable outcomes with nonoperative
strategies have been leading these patients to surgical treatment,
which is associated with good results but a high risk of com-
plications (5% to 21%) and substantial cost25. New strategies
have been proposed in order to improve outcomes with non-
operative treatment, but there are still no reliable and replicated
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published data26. Therefore, the aim of the present study was to
evaluate the efficacy of radial SWT in combination with eccentric
exercises compared with the use of eccentric exercises and sham
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SWT. The primary outcome was tendon function as measured
with use of the Victorian Institute of Sports Assessment-Achilles
questionnaire (VISA-A). We hypothesized that the use of
SWT in combination with eccentric exercises would result in
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improved function in patients with AIT.
Materials and Methods
Trial Design
T his was a double-blinded, placebo-controlled (specifically,
sham-controlled), single-center, randomized clinical trial
with parallel groups. The study was performed at a tertiary
teaching hospital in São Paulo, Brazil. The trial protocol was
approved by the university ethics committee (1373481, 1447/
2015, CAAE 51517415.9.0000.5505), registered at Clinical-
Trials.gov (NCT02757664), previously published27, and fol-
lowed the Standard Protocol Items: Recommendations for
Interventional Trial (SPIRIT) guidelines. This article follows
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the Consolidated Standards of Reporting Trials (CONSORT)
initiative norms.
Patients
Patients were included who were between 18 and 75 years old,
experiencing pain at the calcaneal tendon insertion for at least
3 months, and had a diagnosis of AIT. Diagnosis was determined
by pain through palpation of the Achilles insertion region, the
occurrence of enhanced regional volume, and findings of ten-
dinopathy on ultrasound evaluation. Exclusion criteria were
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bilateral tendinopathy, previous surgery, autoimmune condi-
tions, neuropathy, inflammatory diseases, noninsertional or
mixed tendinopathy, previous infiltration, pregnancy, use of a
pacemaker, coagulopathies, and local infection.
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Calculation of Sample Size
The sample estimate was calculated considering an effect size of
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3.3 with a standard deviation of 16.2 and a sampling error of
5% for the primary outcome (VISA-A)28,29. A total of 93 indi-
viduals, randomly divided into 2 groups, was determined
AR considering that 41 evaluable patients per treatment arm would
have >80% power to detect differences between treatment
groups with significance set at 0.05. A 10% loss to follow-up
was initially anticipated and, therefore, a total of 51 patients per
group was planned for inclusion. As the loss rate reached
20%, a new randomization was performed, and the final
sample settled at 119 patients.
Randomization and Blinding
Randomization, in a 1 to 1 ratio, was performed with use of
www.randomizer.org by creating a list of 1 to 119 with each
number corresponding with a patient and assigning the patient
to a treatment group. A sealed, opaque envelope containing a
single paper stating either “shockwave and eccentrics exercises”
(SWT group) or “placebo and eccentric exercises” (control
group), according to the prior randomization, was prepared for
each patient. Both the randomization and envelope prepara-
tion were performed by an outside researcher with no rela-
tionship to this project.
Patients were assessed individually and were randomized
and allocated in exactly the same manner. Both the treatment
and control procedures were performed in the same fashion,
with identical arrangements and positionings, only diverging in
the removal of the firing apparatus at the therapeutic head of
the device to prevent shockwave propagation in the sham
group. The pistol was still in contact with the patient’s heel, and
patients were able to hear the shock noise and feel the tremble
provoked by the equipment. Patients and medical providers
were blinded, with no access to the group allocation and the
respective procedures throughout the course of the trial. A
different medical provider was responsible for delivering the
shockwave (or placebo) therapy to the patients.
Allocation
Patients were evaluated and demographic data were obtained.
Inclusion and exclusion criteria were reviewed, a physical

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examination was performed, and radiographs and ultraso-
nography were performed. Written consent was obtained, and
baseline scores were determined for each outcome measure.
Finally, patient allocation was implemented, and the treatment
was undertaken. Patients were assessed at baseline and at 2, 4, 6,
12, and 24 weeks after the first intervention.
Treatment Protocols
For the SWT group, the patient was placed in the prone posi-
tion on a stretcher, barefoot, and earmuffs were applied. The
region that would receive the stimulus was marked with ink.
This site corresponded to the highest-bulging area or the
penultimate (in the caudal direction) transverse calcaneal skin
crease. Ultrasound gel was placed. Using a BLT600 (BTL
Medical Technologies), radial shockwaves with 2,000 to 3,000
pulses, a frequency of 7 to 10 Hz, and 1.5 to 2.5 bars of pressure
per application were delivered toward the heel. SWT was
applied on the first treatment day and repeated at 2 and 4 weeks
after the initial treatment.
The same treatment protocol was undertaken for the
control group except that the firing transmission piece was
removed from the therapeutic pistol head prior to initiation of
SWT, impeding shockwave propagation. All other aspects of
the protocol were the same, including the shockwave settings
and the intervals for the repeat sham SWT treatment.
Eccentric Exercises
The Alfredson eccentric training protocol for calf muscles,
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modified by Jonsson et al., was performed for both groups
beginning 2 days after the first intervention5,6. While standing
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on the ground, in a plantar-flexed ankle position (i.e., on tip-
toes), patients were asked to move their body weight to the
affected foot and, only with this side, to begin a slow passive
ankle dorsiflexion while moving downwards until reaching a
plantigrade foot at the ground. Three series of 15 repetitions
with a stretched knee and 3 sets of 15 repetitions with a 20°
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flexed knee were performed twice a day, 7 days per week, for 3
consecutive months. Sports activities were forbidden for
8 weeks after the first intervention27.
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Primary Outcome
The VISA-A is a patient-reported outcome indicating function
that produces a score from 0 to 100, with higher scores being
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better30,31. The primary outcome was established by the VISA-A
at 24 weeks after the first intervention, and a minimal clinically
important difference of 15 points was assumed32-34.
Secondary Outcomes
Secondary outcome measures included the visual ana-
logue scale (VAS) for pain, Foot and Ankle Outcome Score
(FAOS), 12-item Short Form Health Survey (SF-12), and
algometry (pain threshold in kg/f and VAS for pain applying
3 kg/f)29,35-41. Although the American Orthopaedic Foot &
Ankle Society score was included in the protocol, we used it
only to compare with prior studies because of its limited
validity.
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I S O L AT E D E C C E N T R I C E X E R C I S E S F O R AIT
Failure and Recurrence
Failure was determined as an incapacity in achieving an im-
provement from the baseline VISA-A score of at least 15 points
through the 24 weeks of the study33,34. Recurrence was defined as a
decrease in the VISA-A of ‡6 points after the patient had already
achieved an improvement of 15 points32.
Complications
Achilles tendon rupture and complex regional pain syndrome,
as diagnosed by clinical evaluations, were established as
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potential complications.
Statistical Analysis
Normality of distribution was tested for continuous variables
with use of the Kolmogorov-Smirnov test. To assess between-
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group differences in demographic baseline characteristics, anal-
ysis of variance and chi-square tests were performed. For the
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longitudinal analysis, 2-factor repeated-measures analysis of
variance was performed, with a Tukey correction for multiple
comparisons. Recurrence and failure were analyzed for distri-
AR bution with use of the 2-proportion test and were compared with
use of the chi-square test. Pearson correlations and analysis of
variance were applied to measure associations between epide-
miological variables and outcomes. Significance was set at 0.05
for all statistical analyses27. A secondary intention-to-treat anal-
ysis with imputation of missing variables was also performed for
5 possible scenarios (see Appendix).
Results
Patient Flow
O f the 171 patients identified between February 2017 and
February 2019, a total of 119 patients were eligible and
were included in the study, with 58 patients randomized to the
SWT group and 61 to the control group (Fig. 1). No patients
were excluded following randomization, although a total of 23
patients (19.3%) were lost to follow-up at the 24-week assess-
ment. The groups were similar at baseline (Table I), with no
differences in body mass index, age, sex, duration of symptoms,
sports activity, Haglund deformity, traction enthesophyte, pain,
and functional measures (Table I). There were no differences in
baseline or intermediary outcome measures among patients who
completed the 24-week follow-up and those who did not.
Primary Outcome: VISA-A
At the 24-week evaluation, the SWT group exhibited a mean
VISA-A of 63.2 (width of 95% confidence interval, 8.0) com-
pared with 62.3 (95% confidence interval, 6.9) in the control
group (p = 0.876). Both groups showed a significant improve-
ment in function according to the VISA-A over the course of the
study (effect of time on both groups: p < 0.001); however, there
was no significant difference between groups at any time point
(time by treatment effect, p = 0.760) (Fig. 2).
Secondary Outcomes
Both groups showed significant improvement from baseline to
24 weeks in all secondary outcomes (all p < 000.1). No
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I S O L AT E D E C C E N T R I C E X E R C I S E S F O R AIT

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Fig. 1
Consolidated Standards of Reporting Trials (CONSORT) diagram showing patient inclusion and exclusion over the course of the study. CON = control
group.

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TABLE I Patient Characteristics*

SWT Group Control Group P Value

Age 52.2 ± 10.9 (49.4 to 55.0) 53.5 ± 11.4 (50.6 to 56.4) 0.532
Body mass index (kg/m2) 29.5 ± 4.9 (28.2 to 30.8) 28.5 ± 5.1 (27.2 to 29.8) 0.295
Symptom duration (wk) 66.0 ± 96.7 (40.2 to 91.8) 76.2 ± 98.2 (51.1 to 101.3) 0.583
Sports activity 41 (73.2%) 45 (75.0%) 0.826
Enthesophyte 33 (71.7%) 34 (77.3%) 0.547

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Haglund deformity 45 (97.8%) 43 (97.7%) 0.975
Sex 0.642
Female 27 (46.6%) 31 (50.8%)
Male 31 (53.4%) 30 (49.2%)

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*Values are given as the mean ± standard deviation with the 95% confidence interval in parentheses or as the number of patients with the
percentage in parentheses.

differences were found between groups in terms of VAS, SF-12,
algometry, and FAOS (see Appendix).
Intention to Treat
A secondary intention-to-treat analysis with imputation of
missing variables was also performed for 5 possible scenarios.
There was no significant difference between groups in any of
the simulations (see Appendix).
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such as those from Rompe et al. and McCormack et al.18,42.
AR Improvement in secondary outcomes was also consistent with
previous studies, including VAS, AOFAS, and FAOS17,43,44. Some
of these variables (SF-12 and algometry assessment) were novel
to the present study and could not be placed in a comparative
situation with preceding data.
The lack of between-group differences throughout the
course of the study could be explained by the fact that the effects
of shockwave therapy on tissue are reportedly unstable and tend

Failed Treatment and Recurrence to be more apparent later in treatment, as demonstrated in the
A total of 24 failures and 26 recurrences were noticed through studies by Lee et al., Erroi et al., Taylor et al., and Furia15,45-47.
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the research course (Table II). There was a higher rate of failure Wang et al. and Hsu et al. also described late-occurring effects
(38.3%) but a lower rate of recurrence (17.0%) in the SWT with the use of shockwave therapy, reporting a better myofi-
group compared with the control group (11.5% and 34.6%, broblastic orientation at 8 weeks and more mature tenocytes at
respectively; p = 0.002 and p = 0.047). 16 weeks of treatment, respectively48,49. The rates for failed

Complications
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No complications occurred within the 24-week study period.

Discussion
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T he present study assessed the use of radial SWT and

eccentric exercises compared with sham SWT and eccen-
tric exercises for the treatment of AIT and found absence of
superiority for either modality over the course of a 24-week
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follow-up period. Patients experienced a significant and clini-

cally relevant improvement with both therapies, and no com-
plications were reported.

Comparison with the Literature

The present study found that the outcomes of SWTand eccentric
exercises were comparable to those of sham SWT and eccentric
exercises for the treatment of AIT. To our knowledge, this was
the first study to perform this comparison. A significant
improvement in the VISA-A was observed in both groups, which
is consistent with the results of eccentric exercises reported in the
literature. Nonetheless, the VISA-A scores observed in our 2
treatment groups did not exceed those reported in other studies,
Fig. 2
Graph showing the mean VISA-A at baseline (control [CON], 40.6; SWT,
43.9), 2 weeks (control, 47.6; SWT, 43.8), 4 weeks (control, 52.9; SWT,
50.2), 6 weeks (CON, 54.8; SWT, 49.3), 12 weeks (control, 61.8; SWT,
53.7), and 24 weeks (control, 62.3; SWT, 63.2). Whiskers indicate the
95% confidence interval (CI).

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TABLE II Failed Treatment and Recurrence*
Control Group (N = 52)
Failure 6 (11.5%)
Recurrence 18 (34.6%)
*Values are given as the count with the percentage in parentheses.
treatment and recurrence in the present study reinforce the
notion that the effects of shockwave therapy are late-occurring,
as treatment failed more frequently in the SWT group but
recurrence was more frequent in the control group6,50,51.
The finding of comparable outcomes for eccentric exer-
cises with and without shockwave therapy might be supported
by the literature. Hsu et al. reported an increase in the concen-
tration of piridinoline, a collagen maturation marker, at 4 weeks
in rabbit tendons subjected to shockwaves49. However, tissue
provocation during this healing period, such as the recoil of
eccentric exercise stimulus, may disturb this reparative effect.
Han et al. also observed intense new collagen fiber formation in
cultivated tenocytes through the first weeks of SWT52. Clinically,
the reported results of combined eccentric exercises and
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shockwave treatment have also been inconsistent. Rompe et al.
studied the use of SWTwith eccentric exercises in comparison to
isolated eccentrics exercises in patients with noninsertional
tendinopathy and observed differences between groups at
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16 weeks that were not sustained through the 48th week29. Kedia
et al. studied the effects of combined eccentric exercises and a
general muscular strengthening program and reported no dif-
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ferences when compared with eccentric exercises alone53.
In the present study, we observed no associations
between epidemiological or clinical characteristics at baseline
and outcomes. The presence of a Haglund deformity and of an
enthesophyte, which have been verified as signs of a poor
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prognosis, did not seem to affect outcomes in the present
study15,54; however, these characteristics were identified solely
on radiographs. In addition, physical activity was not linked to
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better outcomes, as has been suggested54-56. Furthermore,
duration of symptoms, body mass index, and age—variables
that are traditionally considered to affect outcomes—did not
seem to have a positive or negative effect in the present study54.
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Strengths and Limitations
Study limitations included that recruitment took place at a
single, tertiary center, limiting generalizability. The follow-up
period was relatively short and, therefore, evaluation of the
sustainability and long-term effects of the treatments was not
possible. Still, 24 weeks is a commonly used interval to deter-
mine the success of a treatment. We also had a considerable rate
of loss to follow-up (19.3%), an issue that was mitigated by the
recruitment of a higher number of patients than initially planned
and by the implementation of intention-to-treat analysis. The
previous muscle quality and tendon degeneration, metrics that
are currently being studied for AIT, were not evaluated.
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I S O L AT E D E C C E N T R I C E X E R C I S E S F O R AIT
SWT Group (N = 47) Total (N = 99) P Value
18 (38.3%) 24 (24.2%) 0.002
8 (17.0%) 26 (26.3%) 0.047
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The strengths of this study included its design, which
was randomized, prospective, and double-blinded. Further,
the study protocol was previously registered and published,
reducing the possibility of publication bias. The larger sample
in the literature regarding this disease was presented, and a
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meticulous sham strategy was undertaken. Numerous varia-
bles were appraised and covered different manifestations of
the disease. Finally, the authors did not have any conflicts of
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interest.
Conclusions
In conclusion, treatment of AIT with eccentric exercises in
combination with SWT was comparable to that of eccentric
exercises and sham SWT. The supposed synergic effect from
these treatments was not confirmed by the present study. The
findings of this randomized, placebo-controlled (specifically,
sham-controlled), double-blinded trial do not support the use
of eccentric exercises with SWT as a first-line treatment for AIT.
There remains an unmet need for novel, more effective treat-
ments for AIT.
Appendix
Supporting material provided by the authors is posted
with the online version of this article as a data supplement
at jbjs.org (http://links.lww.com/JBJS/G514). n
NOTE: The authors thank the Departamento de Ortopedia e Traumatologia and the Postgraduate
Program in Translational Surgery from Universidade Federal de São Paulo.
Nacime Salomão Barbachan Mansur, MD, PhD1
Fabio Teruo Matsunaga, MD, PhD1
Oreste Lemos Carrazzone, MD, PhD1
Bruno Schiefer dos Santos, MD1
Carlos Gilberto Nunes1
Bruno Takeshi Aoyama1
Paulo Roberto Dias dos Santos, MD, PhD1
Flávio Faloppa, MD, PhD1
Marcel Jun Sugawara Tamaoki, MD, PhD1
1Escola Paulista de Medicina-Universidade Federal de São Paulo,
São Paulo, Brazil
Email address for N.S.B. Mansur: nacime@nacime.com.br
ORCID iD for N.S. Barbachan Mansur: 0000-0003-1067-727X
ORCID iD for F.T. Matsunaga: 0000-0001-7328-1446
ORCID iD for O.L. Carrazzone: 0000-0003-3090-242X
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ORCID iD for B. Schiefer dos Santos: 0000-0001-9018-6061
ORCID iD for C.G. Nunes: 0000-0002-5547-441X
ORCID iD for B.T. Aoyama: 0000-0003-2079-5608
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