ORIGINAL RESEARCH

Effectiveness of Shockwave Treatment Combined With

Eccentric Training for Patellar Tendinopathy:
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A Double-Blinded Randomized Study

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Karin M. Thijs, MD,* Johannes Zwerver, MD, PhD,† Frank J. G. Backx, MD, PhD,*
Victor Steeneken, PT, MSc,‡ Stephan Rayer, PT,§ Petra Groenenboom, MD,¶ and
Maarten H. Moen, MD PhD*k**

70.9 6 17.8, whereas the VISA-P in the sham-shockwave/

Objective: To evaluate the effectiveness of a combined treatment of eccentric group increased from 58.9 6 14.6 to 78.2 6 15.8
focused shockwave therapy (ESWT) and eccentric training compared (between-group change in VISA-P at 24 weeks 24.8; 95% confi-
with sham-shockwave therapy (placebo) and eccentric training in dence interval, 212.7 to 3.0, P = 0.150).
participants with patellar tendinopathy (PT) after 24 weeks.
Conclusions: This study showed no additional effect of 3 sessions
Design: Randomized controlled trial. ESWT in participants with PT treated with eccentric exercises. The
results should be interpreted with caution because of small sample
Setting: Sports medicine departments of a university hospital and
size and considerable loss to follow-up, particularly in the ESWT
a general hospital in the Netherlands.
group.
Participants: Fifty-two physically active male and female Key Words: sports, tendinopathy, patellar, knee, eccentric, ESWT
participants with a clinical diagnosis of PT (mean age: 28.6 years;
range, 18-45) were randomly allocated to the ESWT (n = 22) or (Clin J Sport Med 2017;27:89–96)
sham shockwave (n = 30).

Interventions: Extracorporeal shockwave therapy and sham

shockwave were applied in 3 sessions at 1-week intervals with INTRODUCTION
a piezoelectric device. All participants were instructed to perform Patellar tendinopathy (PT) is a common sports injury
eccentric exercises (3 sets of 15 repetitions twice a day) for 3 months causing pain most commonly at the origin of the patellar
on a decline board at home. tendon at the inferior pole of the apex patellae as well as
physical dysfunction. It is caused by an overload of the knee
Main Outcome Measures: The Victorian Institute of Sport extensor mechanism. Patellar tendinopathy is often chronic
Assessment-Patella (VISA-P) scores (primary), pain scores during and difficult to treat.1 In the last decade, eccentric training has
functional knee loading tests, and Likert score (secondary) were evolved to be a standard treatment method for PT with 50% to
registered at baseline and at 6, 12, and 24 weeks after the start with 70% chance of improvement at 3 to 6 months of follow-up.2,3
the ESWT or sham-shockwave treatment. Until now, professionals involved in sports medicine have
Results: No significant differences for the primary and secondary been searching for new treatment modalities to more effec-
outcome measures were found between the groups. In the ESWT/ tively treat chronic tendinopathies. Since the early 90s, extra-
eccentric group, the VISA-P increased from 54.5 6 15.4 to corporeal shockwave therapy (ESWT) has been used for
treatment of tendinopathies.4,5 It is theorized that ESWT pro-
duces a regenerative and tissue-repairing effect and inhibits
Submitted for publication April 23, 2015; accepted January 14, 2016. pain receptors.5,6 van Leeuwen et al7 reviewed the effect of
From the *Department of Rehabilitation, Nursing Science and Sport, Univer- ESWT in PT. Their review showed ESWT to be a safe and
sity Medical Centre Utrecht, Utrecht, the Netherlands; †Center for Sports
Medicine Groningen, University Medical Center Groningen, University of promising intervention; however, most studies had limitations
Groningen, the Netherlands; ‡Department of Physical Therapy, Orthopedic in methodological quality. Therefore, it is hard to draw firm
Centre Annatommie MC, Utrecht, the Netherlands; §Department of Phys- conclusions about its overall effectiveness.7 Recently, com-
ical Therapy, Rayer Health Care Physical Therapy, Zoetermeer, the Nether- bined treatment approaches are being applied. The literature
lands; ¶Department of Sports Medicine, Medical Centre Haaglanden, suggests that a combined therapy of eccentric loading and
Leidschendam, the Netherlands; kDepartment of Sports Medicine, Berg-
man Clinics, Naarden, the Netherlands; and **The Sportsphysician Group, shockwave is more effective than eccentric loading alone in
OLVG West, Amsterdam, the Netherlands. chronic Achilles tendinopathy8 and chronic PT after a 3-month
The authors report no conflicts of interest. follow-up.9 It is interesting to examine whether the positive
Corresponding Author: Karin M. Thijs, MD, Department of Rehabilitation, outcome of combined therapy also lasts at long-term
Nursing Science and Sport, Rudolf Magnus Institute of Neuroscience,
University Medical Centre Utrecht, PO Box 85500, 3508 GA, Utrecht,
follow-up.
the Netherlands ([email protected]). The aim of this randomized controlled study [PATELLAr
Copyright © 2016 Wolters Kluwer Health, Inc. All rights reserved. tendinopathy Sham and Shockwave (PATELLASS) study] is to

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 Thijs et al Clin J Sport Med  Volume 27, Number 2, March 2017

determine the effectiveness of a combined treatment of surgery (on the anterior cruciate ligament or the patellar
eccentric training and ESWT compared with eccentric tendon), (4) a local (corticosteroid) injection of the knee in the
training and sham shockwave (placebo) in participants with past month, (5) contraindications for ESWT treatment (eg,
PT during a 24-week follow-up. We hypothesized that pregnancy, malignancy, coagulopathy), or (6) participants
participants treated with this combined approach of eccentric who received ESWT before (ie, these participants are not
training and ESWT will improve significantly more in blinded to the ESWT treatment).
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Victorian Institute of Sport Assessment-Patella (VISA-P)

scores than participants treated with eccentric training and Intervention
sham-shockwave therapy at 24-week follow-up.
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Shockwave Treatment
The focused ESWT and sham-shockwave treatments
METHODS were provided by two independent physical therapists (at 2
different locations in the Netherlands). Both physical thera-
Study Design pists are qualified and experienced in application of ESWT.
The PATELLASS study is a multicenter randomized The device was placed on the most painful spot with the knee
and placebo-controlled trial conducted at the sports medicine extended. Extracorporeal shockwave therapy was applied in 3
departments of a university hospital [University Medical sessions at 1-week intervals with a Piezoelectric ESWT
Center Utrecht (UMCU), Utrecht, the Netherlands] and device (Swiss PiezoClast; Electro Medical Systems, Nyon,
a general hospital [Medical Center Haaglanden (MCH), Switzerland) using 1000 pulses in a frequency of 4 Hz and an
Leidschendam, the Netherlands]. Participants were random- energy density level of 0.2 mJ/mm2. The energy density was
ized to either eccentric exercises in combination with ESWT gradually increased during the session. There is still consider-
(ESWT group) or eccentric exercises in combination with able controversy in ESWT protocols with respect to the num-
sham-shockwave therapy (placebo group). Participants and ber of sessions and dosage. Manufacturers of comparable
outcome assessors were blinded to the designated intervention low–medium dose energy devices consistently recommend
at all time during follow-up at 6, 12, and 24 weeks. The between 3 and 5 sessions.4 Current treatment protocol was
physical therapists providing the shockwave treatment were chosen because of the usability and tolerance in the study of
not blinded to the intervention because they had to adjust Peers.9
the shockwave device to “true” or “sham” treatment. These The sham-shockwave treatment procedure for the
physical therapists were not involved in the follow-up of the control group was nearly the same as the ESWT treatment
participants. and was administered with the same device, in 3 sessions at
1-week interval, using 1000 pulses in a frequency of 4 Hz
Participants and an energy level 1.9,10 Transmission gel was applied
Study participants were recruited from general practi- between the focusing pad and the skin of the participants,
tioners, sports medicine, and physical therapy practices. A but not between the applicator and focusing pad. In this way,
digital letter was sent to potential referring physicians and shockwaves were hardly conducted and had a maximum
physical therapists to inform them about the study. They were energy density level of 0.03 mJ/mm2.10 The participants
asked to refer eligible participants to the sports medicine were told that the treatment could be painful but that there
departments of the UMCU or MCH. All participants who is an interindividual variation in pain perception. By press-
matched the inclusion and exclusion criteria and were willing ing the applicator to the painful spot, the participants expe-
to participate in the study were included. rienced some pain. They also heard the repetitive pulses
Inclusion criteria were the presence of PT in generated by the shockwave device, but were unaware of
participants active in sports at least once a week and an age the dosage.
between 18 and 40 years. Patellar tendinopathy was diag-
nosed by sports medicine physicians based on the following Eccentric Training
clinical findings: (1) history of knee pain located in the All participants were instructed by trained physical
patellar tendon or its patellar insertion related to activity, (2) therapists on how to perform the eccentric exercises on
recognizable palpation tenderness of the patella tendon or its a decline board of approximately 25 degrees at home. Each
insertion on the patella, (3) symptoms present for over 8 training session had to be completed twice daily, with 3 sets
weeks, and (4) the VISA-P score less than 80 at baseline. of 15 repetitions being performed at each session, during 12
During loading, the pain had to remain isolated to the weeks.11 The exercises were performed without warming up.
circumscript part of the tendon or tendon bone junction and The downward (eccentric) component was performed with
not spread to whole patellar region (to distinguish between PT the affected leg, and the upward (concentric) component
and patellofemoral pain). In case of bilateral complaints, the was performed with both legs. Participants were instructed
most painful knee was included. to complete the exercises with the trunk upright. They were
Exclusion criteria were (1) acute knee or acute patellar advised not to exceed a pain level of 4 on a numeric rating
tendon injury, chronic inflammatory joint diseases [(rheuma- scale (NRS) for pain (0 = no pain to 10 = worst pain ever)
toid) arthritis] or signs or symptoms of other (co-) existing during the eccentric training sessions. When pain decreased to
knee pathologies, (2) using immunosuppressive or cortico- NRS ,4, the participants were instructed to add load in
steroid medication in the last 6 months, (3) previous knee a backpack. If pain increased to .5, the participants were

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 Clin J Sport Med  Volume 27, Number 2, March 2017 A Double-Blinded Randomized Study

TABLE 1. Mean 6 SD and Ranges of Baseline Characteristics

Sham Shockwave Total Group Lost to Follow-up
ESWT (n = 22) (n = 30) P (n = 52) at 24 Weeks (n = 11)
Age, yrs 30.5 6 8.0 (18-45) 27.3 6 5.2 (18-40) 0.083 28.6 6 6.7 (18-45) 30.2 6 6.6 (21-41)
Male, % 63.6 80.0 0.189 73.1 63.6
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BMI 23.9 6 3.5 (19.9-32.3) 23.4 6 2.4 (18.1-27.0) 0.492 23.6 6 (18.1-32.3) 24.5 6 3.8 (20.3-32.2)
Hours of sports per week 4.5 6 3.8 (0-16) 4.1 6 2.7 (0-8) 0.673 4.3 6 3.2 (0-16) 4.7 6 4.2 (0-16)
Mean VISA-P 6 SD 54.5 6 15.4 (21-78) 58.9 6 14.6 (20-80) 0.298 57.1 6 14.9 (20-80) 57.7 6 13.7 (38-80)
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Duration of symptoms in weeks 65.1 6 72.7 (12-312) 99.4 6 126.3 (12-500) 0.260 84.9 6 107.4 (12-500) 91.5 6 108.6 (12-312)
Primary sport 7 Running 8 Cycling/spinning
6 Soccer 6 Soccer
1 Athletics 4 Running
1 Basketball 4 Tennis/squash
1 Badminton 2 Athletics
1 Fitness 1 Badminton
1 Field hockey 1 Field hockey
1 Korfball 1 Skating
1 Triathlon 1 Volleyball
1 Gymnastics 1 Kickboxing
1 Aerobics 1 Unknown
BMI, body mass index.

instructed to perform the exercise with less weight or tempo- points.14 With a power of 80% and an alpha of 5%, 28 ath-
rarily adjust the amount of repetitions. letes per group were needed to detect a clinically relevant
Furthermore, they were allowed to perform sport at difference.
a pain level not exceeding NRS 4. No restrictions were given The allocation to treatment took place after baseline
for adjuvant physical therapy treatment, but it was not assessment by the sports medicine physician. Randomization
encouraged. Adjuvant treatment was registered at follow-up. (simple randomization procedure) was performed using
sealed identical nonopaque envelopes containing cards with
Outcome “A” or “B” on it. An independent nurse at each of the loca-
The primary outcome measure was the validated Dutch tions was responsible for preparation and execution of this
translation of the VISA-P questionnaire, which quantifies the procedure. Slightly more envelopes per location were pre-
pain and activity level and is specifically designed for pared as was calculated in the power analysis, because we
evaluating outcome in PT.12,13 The VISA-P score ranges from intended to include more participants than strictly needed.
0 to 100 (0 = no activity/maximum pain and 100 = maximum After opening the envelope, the card with “A” or “B” on it
activity/no pain). was handed over to the physical therapist on that location.
Secondary outcome measures were pain scores during The 2 care providers (physical therapists) providing the
functional knee loading tests, as rated verbally by a NRS for (sham-) shockwave treatment were the only ones who knew
pain on a scale of 0 to 10 (0 = no pain and 10 = worst pain the representation of “A” or “B.” Allocation information was
ever). The pain was scored during 10 single-leg decline withheld from the participants and the outcome assessors for
squats, during 3 single-leg jumps, and during 3 single-leg the duration of the data collection (24 weeks).
maximal vertical jumps of the affected leg.10 Satisfaction
was rated on a 6-point Likert scale at follow-up assessments Statistical Methods
(1: completely recovered; 2: much better; 3: a little better; 4: Baseline characteristics and outcome measures at
unchanged; 5: worse; and 6: much worse). follow-up were tabulated using descriptive statistics (mean
Follow-up measurements were performed at 6, 12, and and SDs, numbers, and percentages). Independent sample
24 weeks after the start with the ESWT or sham-shockwave t-tests were used to assess the difference between baseline
treatment. Side effects, adverse reactions, and the compliance characteristics and the number of exercise sessions between
to eccentric exercises were recorded. the groups. Differences between categorical data were
assessed by the x2 test. Repeated-measures analysis was used
Sample Size, Randomization, and Blinding to assess the difference on the primary and secondary out-
The sample size was estimated based on the difference come variables between the groups over time. Analyses were
in VISA-P scores between symptomatic and asymptomatic performed following the intention-to-treat principle (both
participants, with a clinically relevant difference in VISA-P mean value substitution and last observation carried forward
scores of 15 points. Baseline scores of 64 points were were performed; results for mean value substitution were
expected in symptomatic participants with an SD of 19 given). Two-sided P values of ,0.05 were considered

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 Thijs et al Clin J Sport Med  Volume 27, Number 2, March 2017

significant. All statistical analyses were performed using IBM scores were 55.9 6 15.4 for the group that completed the
SPSS Statistical software package version 20 (SPSS Inc, study protocol and 57.7 6 13.7 for the lost-to-follow-up
Chicago, Illinois). group (P = 0.871).
The mean number of eccentric exercise sessions per
Ethical Considerations week (maximum of 14) for the ESWT and placebo group was
The Medical Ethical Committee of the UMCU and 10.1 6 4.5 and 9.8 6 3.8 sessions at 6 weeks (P = 0.753) and
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MCH approved the study protocol before its start (protocol 8.7 6 4.2 and 6.1 6 5.2 sessions at 12 weeks (P = 0.065),
number 10/202/C). All participants were fully informed about respectively.
the nature of the trial and its rationale. All participants Because of the low number of reported cointerventions
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provided written informed consent. in both groups, the possible influence of cointerventions on
the primary outcome (VISA-P) was not further examined.

RESULTS Primary Outcome Measure

The mean baseline VISA-P scores were 54.5 6 15.4 for
Study Participants the ESWT group and 58.9 6 14.6 for the placebo group (P =
Fifty-two athletes were randomized into the ESWT or 0.298). Both groups improved over time to 70.9 6 17.7 and
sham-shockwave group. Baseline characteristics are pre- 78.2 6 15.8 at 24 weeks, respectively (P = 0.150) (Figure 2).
sented in Table 1, showing no significant group differences. The mean changes in VISA-P scores from baseline according
Baseline characteristics and VISA-P scores (56.7 6 13.6 vs to treatment group are shown in Table 2. The results show
57.6 6 17.0 points) were not significantly different between a significant effect for time (P = 0.000), but no interaction
the 2 locations either. During follow-up, 7 athletes (31.8%) in effect for treatment · time (P = 0.740). Analyses of the pri-
the ESWT group and 4 athletes (13.3%) in the placebo group mary outcome, both with and without imputation of missing
were lost to follow-up (see flow diagram of the study, Figure data, did not alter the outcome. The results were similar for
1). All participants completed the 3 sessions of ESWT or both mean value substitution and last observation carried for-
sham-shockwave treatment. The mean baseline VISA-P ward (data of the mean value substitution are presented).

FIGURE 1. Flow diagram of study

participants.

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 Clin J Sport Med  Volume 27, Number 2, March 2017 A Double-Blinded Randomized Study
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FIGURE 2. Mean VISA-P scores (SD)

at baseline, 6, 12, and 24 weeks in
ESWT and sham-shockwave group
(placebo). FU, follow-up.

Secondary Outcome Measure The Likert scores for patient satisfaction are presented in
The mean NRS scores at baseline and follow-up are Table 3, showing no significant differences between the 2 groups
presented in Table 2. Both groups significantly improved over at 6, 12, and 24 weeks (P = 0.127, P = 0.755, and P = 0.928
the study period. No significant differences were found respectively). Sixty-seven percent in ESWT and 69% in the
between the ESWT and the sham-shockwave group (except sham-shockwave group reported good outcomes after 24 weeks
for pain during 3 maximal vertical jumps at 6 weeks, in favor (much better or completely resolved). No complications were
of the sham-shockwave group). reported after ESWT or sham-shockwave treatment.

TABLE 2. Primary and Secondary Outcome Measures at Baseline, 6, 12, and 24 Weeks in ESWT and Sham-Shockwave Group
(Placebo)
ESWT (n = 22) Sham Shockwave (n = 30)
Baseline, Week 6, Week 12, Week 24, Baseline, Week 6, Week 12, Week 24,
Mean (SD) Mean (SD) Mean (SD) Mean (SD) Mean (SD) Mean (SD) Mean (SD) Mean (SD)
VISA-P score (0-100) 54.5 (15.4) 61.4 (19.2) 65.7 (17.3) 70.9 (17.7) 58.9 (14.6) 67.3 (17.8) 71.5 (21.7) 78.2 (15.8)
Pain during 10 decline 4.1 (2.4) 3.3 (2.4) 2.0 (1.5) 1.8 (1.8) 4.7 (2.5) 3.1 (2.7) 2.9 (2.5) 2.2 (2.3)
squats (0-10)
Pain during 3 single- 3.3 (2.6) 3.5 (2.9) 2.4 (1.7) 1.8 (1.8) 3.2 (2.7) 2.3 (1.8) 2.3 (2.2) 1.9 (1.9)
leg jumps (0-10)
Pain during 3 maximal 2.8 (2.9) 3.3 (2.3) 2.1 (1.7) 1.6 (1.9) 3.8 (2.4) 2.0 (2.0) 2.2 (2.0) 1.5 (1.9)
vertical jumps (0-10)
Between-Group Between-Group Between-Group
Difference Difference Difference
(95% CI), Week 6 (95% CI), Week 12 (95% CI), Week 24
VISA-P score (0-100) 21.4 (29.0 to 6.2) 23.0 (12.3 to 6.3) 24.8 (212.7 to 3.0)
Pain during 10 decline squats (0-10) 0.8 (20.6 to 2.2) 20.4 (21.5 to 0.8) 0.4 (21.0 to 1.9)
Pain during 3 single-leg jumps (0-10) 1.0 (20.3 to 2.4) 20.1 (21.4 to 1.2) 20.2 (21.6 to 1.2)
Pain during 3 maximal vertical jumps 2.2 (0.9 to 3.4)* 0.6 (20.6 to 1.8) 1.2 (20.2 to 2.5)
(0-10)
*P , 0.05.
CI, confidence interval.

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 Thijs et al Clin J Sport Med  Volume 27, Number 2, March 2017

TABLE 3. Likert Scores, Frequencies (Percentage)

ESWT Sham Shockwave
Likert Score n = 21; 6 wk n = 18; 12 wk n = 15; 24 wk n = 29; 6 wk n = 25; 12 wk n = 26; 24 wk
1: completely recovered — — 2 (13.3) — 2 (8.0) 5 (19.2)
2: much better 6 (28.6) 6 (33.3) 8 (53.3) 9 (31.0) 9 (36.0) 13 (50.0)
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3: a little better 8 (38.1) 5 (27.8) 2 (13.3) 14 (48.3) 5 (20.0) 5 (19.2)

4: unchanged 7 (33.3) 4 (22.2) 2 (13.3) 3 (10.3) 5 (20.0) 2 (6.7)
5: worse — 3 (16.7) 1 (6.7) 3 (10.3) 3 (12.0) 1 (3.3)
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6: much worse — — — — 1 (4.0) —

DISCUSSION a mixture of conservative treatments (including eccentric

The present randomized controlled trial (RCT) showed exercises for the patellar tendon). A large difference in
no favorable effects of a combined treatment of eccentric VISA-P score was found in favor of the ESWT group
loading and ESWT over a treatment approach with eccentric (P , 0.05), with almost no progression in the control group
loading and sham shockwave in participants with PT during after a follow-up ranging from 10 to 48 months. The base-
a 24-week follow-up period. Victorian Institute of Sport line VISA-P scores were however much lower than those in
Assessment-Patella and pain scores significantly improved this study. Again, this might have influenced the results in
over the study period, but there was no treatment effect favor of ESWT. The prospective and retrospective studies
between the groups over time. Sixty-seven percent in the all showed a generally positive effect of ESWT on the
ESWT group and 69% in the placebo group reported distinct improvement of the VISA-P score.19–21 Based only on the
improvement of symptoms. RCTs, conflicting evidence is available that ESWT is more
One study investigated the effect of eccentric training effective than other conservative treatments for chronic PT.
combined with ESWT for chronic PT. In the thesis of Peers,9 This could be a major reason for the lack of difference
21 participants with PT for over 3 months, who were treated between the groups in our study. Other factors that could
with eccentric exercises and ESWT, improved significantly explain the discrepancies between the outcomes of the RCTs
more in VISA-P scores at 12-week follow-up compared with are the differences in study population (athletes vs patients;
the 20 participants treated with eccentric exercises and sham different baseline VISA-P scores; various stages of tendi-
shockwave. The change in VISA-P scores of the ESWT nopathy) and differences in instrumental settings of the
group was 19 at 6 weeks and 17 at 12 weeks. These results shockwave device (differences in focal depth and number
obviously differ from the findings in our study, in which the and intensity of pulses). This makes it hard to compare the
increase in VISA-P score is much less, despite identical results.5
ESWT energy density levels and sessions. However, the Reviews on eccentric training for PT generally show
device was different from ours and their focus area was a positive effect on VISA-P over time.22,23 However, in
the tendinosis zone of the patellar tendon instead of the most several studies, for example by Frohm et al and Young
painful spot.9 Furthermore, the VISA-P baseline values were et al, the increase in VISA-P after 12 weeks of eccentric
lower in the Peers study (46.5 for the ESWT group and 53.8 training is larger compared with our study (approximately
for the sham-shockwave group) compared with ours. This 20-40 VISA-P points compared with our 10-point increase
might have influenced the results, as it seems that ESWT is in the group that received eccentric training and sham
more effective in more advanced stages of late dysrepair or shockwave).24,25 Possibly, the variations in study popula-
degenerative tendinopathy (representing lower baseline tions may account for the differences. The Young study
VISA-P scores).10,15 Mani-Babu et al16 recently published only analyzed elite volleyball players (N = 17), whereas
a review that compared the effect of ESWT with other con- this study examined recreational athletes from various
servative treatment options in lower extremity tendinopa- sports. The etiological factors for PT, including amount
thies. Six studies for PT could be included; 3 RCTs, 2 of tendon loading, are most likely not the same in both
prospective studies, and 1 retrospective study. The 3 RCTs populations, which will possibly influence the outcome as
showed mixed effects. In the study by Taunton et al17 with well. Moreover, the athletes in the Frohm study (N = 20)
20 participants, the ESWT group improved significantly were frequently supervised during their exercises and dur-
more in VISA-P scores than the sham-shockwave group. ing their return-to-sports after an initial 6 weeks of rest,
In the RCT conducted by Zwerver et al, athletes (N = 62) whereas athletes in our study performed the exercises unsu-
were randomized between ESWT and sham-shockwave pervised at home. This guidance might have positively
treatment. The athletes were allowed to continue to practice influenced participants’ compliance to the exercises and
sports during the treatment. Although the VISA-P score in sport advice.
both groups improved over time (end of follow-up after 22
weeks), no significant differences were found between the Limitations
groups (P = 0.82).10 The baseline VISA-P scores were Results of this study should be interpreted with some
higher (60.9 6 12.6) compared with this study. In the Wang caution. There was a large loss to follow-up; 31.8% in the
et al18 randomized study, ESWT was compared with ESWT and 13.3% in the sham-shockwave group at 24 weeks.

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 Clin J Sport Med  Volume 27, Number 2, March 2017 A Double-Blinded Randomized Study

However, this difference in lost to follow-up percentage was with eccentric exercises. The primary (VISA-P) and second-
not significant between the groups and no significant differ- ary outcome measures (pain scores during functional tests and
ences were found for baseline characteristics and VISA-P Likert scores) did not differ significantly between the groups
scores between participants lost to follow-up and participants during the 24-week follow-up period. Because of low power
who completed the full 24-week follow-up period, irrespec- of the study caused by a high percentage of participants lost to
tively of the treatment group. This makes attrition bias less follow-up, particularly in the ESWT group, these conclusions
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likely in this study. should be interpreted with caution.

The fact that the physical therapists (who performed the
treatments) were unblinded could have influenced the results.
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