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Clinically Relevant Effectiveness of Focused
Extracorporeal Shock Wave Therapy in the
Treatment of Chronic Plantar Fasciitis
A Randomized, Controlled Multicenter Study
Hans Gollwitzer, MD, Amol Saxena, DPM, Lawrence A. DiDomenico, DPM, Louis Galli, DPM,
Richard T. Bouch´
e, DPM, David S. Caminear, DPM, Brian Fullem, DPM, Johannes C. Vester,
Carsten Horn, MD, Ingo J. Banke, MD, Rainer Burgkart, MD, and Ludger Gerdesmeyer, MD
Background: The effectiveness of extracorporeal shock wave therapy in the treatment of plantar fasciitis is controver-
sial. The objective of the present study was to test whether focused extracorporeal shock wave therapy is effective in
relieving chronic heel pain diagnosed as plantar fasciitis.
Methods: Two hundred and fifty subjects were enrolled in a prospective, multicenter, double-blind, randomized, and
placebo-controlled U.S. Food and Drug Administration trial. Subjects were randomized to focused extracorporeal shock
wave therapy (0.25 mJ/mm
2
) or placebo intervention, with three sessions of 2000 impulses in weekly intervals. Primary
outcomes were both the percentage change of heel pain on the visual analog scale composite score (pain during first
steps in the morning, pain with daily activities, and pain with a force meter) and the Roles and Maudsley score at twelve
weeks after the last intervention compared with the scores at baseline.
Results: Two hundred and forty-six patients (98.4%) were available for intention-to-treat analysis at the twelve-week
follow-up. With regard to the first primary end point, the visual analog scale composite score, there was a significant
difference (p =0.0027, one-sided) in the reduction of heel pain in the extracorporeal shock wave therapy group (69.2%)
compared with the placebo therapy group (34.5%). Extracorporeal shock wave therapy was also significantly superior to
the placebo therapy for the Roles and Maudsley score (p =0.0006, one-sided). Temporary pain and swelling during and
after treatment were the only device-related adverse events observed.
Conclusions: The results of the present study provide proof of the clinically relevant effect size of focused extracorporeal shock
wave therapy without local anesthesia in the treatment of recalcitrant plantar fasciitis, with success rates between 50% and 65%.
Level of Evidence: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.
Plantar fasciitis is the most common cause of heel pain
1-3
,
and nonsurgical treatment is successful in about 90% of
patients
1,2,4
. A relevant proportion of patients who fail
nonoperative care are treated with surgery
1,2,4,5
.
Extracorporeal shock wave therapy has been introduced for
the treatment of chronic inflammatory and degenerative pro-
cesses of bone-tendon junctions since the induction of hyper-
emia, neovascularization, and regeneration of tendon tissue have
Disclosure: One or more ofthe authors received payments or services, either directly or indirectly (i.e., via his or her institution), from a third party in supportof
an aspect of this work. In addition, one or more of the authors, or his or her institution, has had a financial relationship, in the thirty-six months prior to
submission of thiswork, with an entity in the biomedicalarena that couldbe perceived to influence or have the potential to influencewhatiswritteninthiswork.
No author has had any other relationships, or has engaged in any other activities, that could be perceived to influence or have the potential to influence what is
written in this work. The compl ete Disclosures of Potential Conflicts of Interest submitted by authorsare always provided with the online version of the article.
Peer Review: This article was re viewed by the Editor-in-Chief and one Deputy Editor, and it unde rwent blinded review by two or more outside experts. It was also re viewed
by an expert in methodology and statis tics. The Deputy Editor reviewed each revision of the article , and it underwent a final review by the Editor-in-Chief prior to publication.
Final corrections and clarifications occurred during one or more exchanges between the author(s) and copyeditors.
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COPYRIGHT 2015 BY THE JOURNAL OF BONE AND JOINT SURGERY,INCORPORATED
J Bone Joint Surg Am. 2015;97:701-8 dhttp://dx.doi.org/10.2106/JBJS.M.01331
been demonstrated. Established indications are calcifying ten-
dinitis of the shoulder, Achilles tendinopathy, and chronic painful
heel syndrome
6-9
. However, the effectiveness of extracorporeal
shock wave therapy in plantar fasciitis is controversial
2,5,7,10 -14
,and
the superiority of extracorporeal shock wave therapy compared
with a placebo was summarized in systematic reviews as being
significant but not clinically relevant
2,15
. Specific treatment pa-
rameters of extracorporeal shock wave therapy are of importance
for treatment success but have been neglected in systematic re-
views
3,7,11,1 2,16
. First, local anesthesia has been shown to reduce
efficacy
17,18
. Second, higher total shock wave energies have been
associated with greater pain reduction
7,19,20
.Third,focusedshock
waves have demonstrated clinical superiority compared with
radial shock waves
21
. Consequently, pooling data of more and less
effective treatment protocols in systematic reviews underesti-
mates the real effectiveness of optimized extracorporeal shock
wave therapy protocols.
Clinically relevant effectiveness of extracorporeal shock wave
therapy has been shown in previous studies applying high but
tolerable shock wave energies to the point of maximum tenderness
without local anesthesia
7,8,12,22
. The present study was performed to
evaluate the effectiveness of an optimized treatment protocol of
extracorporeal shock wave therapy in chronic plantar fasciitis.
Materials and Methods
Study Design and Follow-up
This double-blind, randomized, placebo-controlled trial with parallel group
design was conducted at five study centers in the United States. A total of
250 patients were randomly assigned to receive either focused extracorporeal
shock wave therapy or placebo intervention. Randomizationwas performed with
concealed allocation in permuted blocks of four to eight, stratified by treatment
center, with the use of a computer-generated random list and nontransparent
envelopes. Whereas the treating physician (A.S., L.A.D., L.G., R.T.B., and D.S.C.)
was nonblinded, both participants and evaluating physicians were blinded to
randomization. The trial was registered and was conducted as a U.S. Food and
Drug Administration (FDA) approval study (Investigational Device Exemption
number IDE G050236). Standardized guidelines of good clinical practices from
the International Conference on Harmonisation of Technical Requirements
for Registration of Pharmaceuticals for Human Use (ICH) were respected.
After three interventions of shock waves or a placebo in weekly intervals,
patients were followed for twelve weeks after the last intervention (follow-up 1).
At this visit, the participants’response to treatment was rated. Individuals who
met the predefined criteria for treatment success at the time of follow-up
1 continued until twelve months after the last intervention (follow-up 2) to
assess intermediate-term stability of treatment success. Subjects who did not
show sufficient improvement discontinued the study after follow-up 1 and were
not included in follow-up 2. Treatment was considered successful if there was at
least 60% reduction in pain on two of three visual analog scale (VAS) scores or,
alternatively, if all three of the following criteria were fulfilled: the study participant
was able to work, the participant was satisfied with the treatment outcome, and no
concomitant therapy to control heel pain was required.
Subjects
The study was approved by the FDA and the responsible independent institutional
review boards. Written informed consent was obtained from all participants.
Patients were recruited from the participating study sites and from community-
based referring physicians (primary care physicians, podiatrists, and ortho-
paedic surgeons). A total of 250 patients were randomized. The Consolidated
Standards of Reporting Trials (CONSORT) diagram for the study is displayed
in Figure 1.
TABLE I Demographic and Baseline Characteristics of the Intention-to-Treat Population
Intention-to-Treat Population
Characteristic
Extracorporeal Shock Wave
Therapy Group (N = 125)
Placebo Group
(N = 121)
Age* (yr) 50.0 ±11.2 47.4 ±10.6
Male sex 32.0% 27.3%
Body mass index* (kg/m
2
)28.6 ±6.18 29.5 ±7.19
Activity†
Sedentary 7 (5.6%) 14 (11.6%)
Active 101 (80.8%) 87 (71.9%)
Athletic 17 (13.6%) 20 (16.5%)
Heel pain duration†
Six to twelve months 40 (32.0%) 37 (30.6%)
More than twelve to twenty-four months 38 (30.4%) 37 (30.6%)
More than twenty-four months 47 (37.6%) 47 (38.8%)
VAS* (points)
Heel pain while taking first steps in the morning 7.9 ±1.55 8.0 ±1.61
Heel pain while doing daily activities 7.9 ±1.55 7.9 ±1.51
Heel pain after application of the F-Meter 9.3 ±1.25 9.3 ±1.28
Roles and Maudsley score* (points) 3.6 ±0.49 3.7 ±0.48
*The values are given as the mean and the standard deviation. †The values are given as the number of patients, with the percentage in
parentheses.
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EXTRACORPOREA L SHOCK WAVE THERAPY FOR PLANTAR FASCIITIS
Inclusion Criteria
Inclusion required a history of plantar fasciitis resistant to nonsurgical treat-
ment for at least six months. All participants had failed at least four nonsurgical
treatment modalities, including at least two nonpharmacological and at least
two pharmacological treatments. Diagnosis of plantar fasciitis was made by
experienced foot and ankle specialists with more than ten years of professional
experience according to the clinical practice guideline of the American College
of Foot and Ankle Surgeons
1
. Magnetic resonance imaging (MRI), nerve
conduction velocity/electromyography, or other diagnostic testing was per-
formed if appropriate to confirm plantar fasciitis or to rule out other diagnoses.
Fig. 1
A CONSORT diagram showing the flow of participants through the study. The safety analysis population included all patients receiving at least one
treatment session. The intention-to-treat (ITT) population included all subjects who had had at least one treatment session and also at least one evaluation
following the first treatment without severe deviation of entry criteria (i.e., the ITT population was the full analysis set as defined in the ICH guideline
E9 [biostatistics]
25
). The per-protocol (PP) population also included the patients excluded from the intention-to-treat population because of protocol
violations (inclusion and exclusion criteria, incomplete study treatment, or premature discontinuation). ESWT =extracorporeal shock wave therapy, and
AE =adverse event.
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Participants had to self-rate ‡5 points on all three VAS scores (heel pain while
taking the first steps in the morning, heel pain while doing daily activities, and
heel pain while applying a standardized local pressure with the Force-Meter [F-
Meter; Storz Medical, T¨agerwilen, Switzerland]). Pain was measured on a 10-cm
VAS in which 0 points indicated no pain and 10 points indicated excruciating
pain. To be eligible, subjects must also have had a Roles and Maudsley score of fair
or poor
23
. A minimum washout phase after preceding nonsurgical treatments
was required prior to enrollment (a time gap of at least six weeks since the last
corticosteroid injection; four weeks since the last local anesthetic injection,
iontophoresis, ultrasound, or electromyostimulation; one week since the last
nonsteroidal anti-inflammatory drugs; and two days since the last analgesics,
heat, ice, massage, stretching, modification of night splinting, and orthosis). The
complete list of inclusion criteria is summarized in the Appendix.
Exclusion Criteria
The main reasons for exclusion were active infection or history of chronic
infection in the treatment area, systemic inflammatory disease, neurological or
vascular insufficiencies, nerve entrapment, disturbance of coagulation, bilateral
heel pain in need of medical treatment, and pregnancy. The complete list of
exclusion criteria is provided in the Appendix.
Study Interventions
Focused shock waves were generated electromagnetically with the Duolith SD1
shock wave device (Storz Medical). The total energy flux density was increased
continuously from 0.01 to 0.25 mJ/mm
2
within 500 introductory impulses.
Thereafter, 2000 treatment impulses with 0.25 mJ/mm
2
(four impulses per
second) were administered per session, and the intervention was repeated up to
a total of three sessions in weekly intervals.
The placebo group received identical sham intervention with an air-
filled standoff that prevented the transmission of shock waves. The placebo
handpiece was identical in design, shape, and weight to ensure that there was no
way for the participants to identify the placebo handpiece.
The applicator was directed to the most tender point, controlling
proper placement by patient-controlled feedback, and was adjusted during
treatment if necessary. No radiograph or ultrasound was used. The participants
had the option to request local anesthesia.
The participants were allowed to use a standardized rescue medication
throughout the study (2 g of acetaminophen per day for up to fourteen days
following the last intervention; thereafter, 2 g of acetaminophen per week). No
other therapies were allowed.
Primary Outcome Measures
One of the primary outcomes was the overall reduction of heel pain, measured
by percentage change of the VAS composite score twelve weeks after the last
intervention compared with the score at baseline. The heel pain composite
score was defined as the sum of three single VAS scales: (1) heel pain while
taking the first steps in the morning, (2) heel pain while doing daily activities,
and (3) heel pain while applying a standardized local pressure with the F-Meter.
The blinded investigator (one of whom [B.F.] was an author of this
study) used the F-Meter to measure pressure sensitivity at the point of maxi-
mum tenderness. The pressure level that just elicited unbearable pain (a VAS
score of 10 points) was quantified by the F-Meter and was documented as an
individual baseline value for each participant. At each follow-up visit, the same
individual F-Meter pressure was then applied and the subject was asked to score
the pain on the VAS. An increased pressure pain tolerance resulted in a decreased
scoring in the VAS.
Functional improvement was measured by the Roles and Maudsley
score
23
, which is a four-level grading scale: excellent indicates no pain, full
movement, and activity; good indicates occasional discomfort, full move-
ment, and activity; fair indicates some discomfort after prolonged activity;
and poor indica tes pain-limiting activities. Because we wished to maintain the
overall alpha level for the study, both of the primary efficacy criteria would
need to be significantly superior (one-sided p < 0.025) to prove the superi-
ority of the intervention. Primary outcome measures were analyzed with the
last value carried forward to replace missing values and with correction for
interfering analgesic therapy. Potential limitations of using percentage
changes in pain VAS scales were avoided by the use of robust nonparametric
statistics.
Secondary Outcome Measures
Secondary outcome measures included the investigator’s (one of whom [B.F.]
was an author of this study) global judgment of effectiveness (on a 5-point scale
ranging from very good to poor), rates of success defined as at least 60% pain
reduction in the single VAS scores, the overall rate of success with regard to
heel pain defined as at least 60% decrease of heel pain in at least two of the
three VAS measurements, the Roles and Maudsley score rate of success
defined as a rating of excellent or good, and the consumption of concomitant
analgesic medication (all at twelve weeks after treatment). Additionally, par-
ticipants’judgment of satisfaction with therapy was assessed on a nonvalidated
7-point scale (ranging from very satisfied to very unsatisfied) at that time
(follow-up 1).
Furthermore, the VAS composite score, the Roles and Maudsley score,
and success rates were assessed at the time of follow-up 2 for the subpopulation
that demonstrated sufficient response to treatment at the time of follow-up 1.
Safety Criteria
All subjects with at least one intervention were included in the safety anal-
ysis population. All local tissue effects and adverse events were recorded.
TABLE II Primary Efficacy Criteria at Twelve Weeks (Follow-up 1)
Intention-to-Treat Groups
Primary Efficacy Criteria*
Extracorporeal Shock Wave
Therapy Group (N = 124) Placebo Group (N = 121) P Value†
Mann-Whitney
Effect Size‡
Composite score for heel pain (VAS)§ 0.0027 0.6026 (0.5306)
Median change from baseline# 269.2% 234.5%
Mean change from baseline** 254.5% (261.4% to 247.7%) 240.3% (247.5% to 233.1%)
Roles and Maudsley score** (points) 2.5 (2.3 to 2.7) 2.9 (2.7 to 3.1) 0.0006 0.6135 (0.5466)
*All results have the last value carried forward to replace missing values and score correction for interfering concomitant therapy. †The p values
were determined by a one-sided test for superiority with use of the Wilcoxon-Mann-Whitney test. ‡The values are given as the effect size, with the
lower bound of the one-sided 97.5% confidence interval in parentheses. §The values are the sum of scores of heel pain (VAS) while taking the first
steps of the day, heel pain (VAS) while doing daily activities, and heel pain (VAS) after application of the F-Meter. #The values are given as the
median. **The values are given as the mean, with the 95% confidence interval in parentheses.
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Additionally, the investigator’s global judgment of tolerability was assessed on a
7-point rating scale twelve weeks after the last treatment.
Statistical Analysis
The sample size calculation was based on the model of stochastic superiority
within the Wilcoxon-Mann-Whitney test for the primary outcome measure of
percentage change of the VAS composite score. The following stipulations were
made: a relevant Mann-Whitney effect size of 0.64, an alpha (one-sided) of
0.025, and a beta of 0.10 (power of 90%). Because of the expected usual losses
(for example, dropouts), the sample size for the study was enhanced to 125
participants per group.
To keep the multiple levels of alpha, the efficacy of the extracorporeal
shock wave therapy was proven if both primary criteria of effectiveness (the
VAS composite score and the Roles and Maudsley score) showed a significant
result with a value of p < 0.025 (one-sided).
To identify differences in effect size between the groups, the Mann-
Whitney effect size with predefined benchmarks was used. In accordance with
Colditz et al.
24
, we used benchmarks that corresponded to a Mann-Whitney
effect size of 0.5 for equality (active therapy was neither better nor worse than
the placebo), 0.44 or 0.56 for small inferiority or superiority, 0.36 or 0.64 for
medium (clinically important) inferiority or superiority, and 0.29 for large
inferiority or 0.71 for large superiority.
Primary and secondary criteria were evaluated by univariate Wilcoxon-
Mann-Whitney tests. In addition, secondary criteria were combined by a
multivariate directional Wilcoxon test (the Wei-Lachin procedure). Statistical
analyses were performed by an independent institute (idv-Data Analysis and
Study Planning, Gauting, Germany), using its REPORT, TESTIMATE, and
AE-Base software programs, which is in accordance with the recommendations
of the ICH E9 Biostatistics Guideline
25
.
Source of Funding
The present study was conducted as anFDA-approved study. Three authors (H.G.,
A.S., and J.C.V.) received funding from Storz Medical. Funds were used to pay
for travel expenses, consultancy in study planning, and realization. The sponsors
of this study did not have any influence on subject recruitment, data collection,
data analysis, or preparation of the manuscript.
Results
Enrollment and Treatment
Atotal of 250 patients were enrolled over a fifty-week period
and were randomly assigned to extracorporeal shock wave
therapy (n =126) or placebo intervention (n =124). The flow of
participants through the study is displayed in the Consolidated
Standards of Reporting Trials (CONSORT) diagram (Fig. 1).
Both groups showed comparable characteristics with respect to
demographic variables, intensity and duration of heel pain (Table
I), and previous therapies. No subject requested local anesthesia.
Primary Outcome Measures
The primary end points of the percentage change in the VAS
composite score and the Roles and Maudsley score at twelve
weeks compared with the scores at baseline could be assessed in
TABLE III Secondary Efficacy Criteria at Twelve Weeks (Follow-up 1)
Secondary Efficacy Criteria*
Intention-to-Treat Group
P Value
Odds
Ratio
No. of
Patients
Needed
to Treat
Extracorporeal Shock Wave
Therapy†(N = 125) Placebo†(N = 121)
Success rate‡
Heel pain overall§ 54.4% (45.3% to 63.3%) 37.2% (28.6% to 46.4%) 0.0035# 2.015 5.8
Heel pain while taking first steps of
the day**
50.4% (41.3% to 59.5%) 36.4% (27.8% to 45.6%) 0.0136# 1.778 7.1
Heel pain during daily activity** 49.6% (40.5% to 58.7%) 38.8% (30.1% to 48.1%) 0.0464# 1.550 9.3
Heel pain with F-Meter** 53.6% (44.5% to 62.6%) 42.2% (33.2% to 51.5%) 0.0380# 1.586 8.7
Roles and Maudsley score†† 60.8% (51.7% to 69.4%) 37.2% (28.6% to 46.4%) 0.0001# 2.620 4.2
Investigator’s global judgment of
effectiveness: very good or good‡‡
73.9% (88 of 119) 54.4% (62 of 114) 0.0110§§
Subject’s global judgment of therapy
satisfaction: very satisfied or satisfied‡‡
47.9% (57 of 119) 33.3% (38 of 114) 0.0021§§
Concomitant analgesic medication‡## 74.4% (65.8% to 81.8%) 71.1% (62.1% to 79.0%) 0.7420# 0.846
*All results have the last value carried forward to replace missing values and score correction for interfering concomitant therapy. †According to
the predefined criteria for response to treatment to continue the study after follow-up 1, a sufficient response was considered to be at least 60%
reduction in pain on two of three VAS scores (heel pain overall success rate) or, alternatively, if all three of the following criteria were fulfilled: the
study participant was able to work, the participant was satisfied with the treatment outcome, and no concomitant therapy to control heel pain was
required. The response to treatment for the decision to continue until follow-up 2 was eighty-one patients (64.8%) in the extracorporeal shock wave
therapy group and fifty-six patients (46.3%) in the placebo group. ‡The values are given as the mean percentage of patients, with the 95%
confidence interval in parentheses. §Success was defined as a decrease of heel pain of at least 60% from baseline for at least two of three heel
pain VAS measurements. #The p values of the one-sided test for superiority were determined with use of the unconditional exact R¨ohmel-
Mansmann test. **Success was defined as a decrease of heel pain of at least 60% from baseline. ††These values were the percentage of
subjects with a Roles and Maudsley score of excellent or good at the time of follow-up 1. ‡‡The values are given as the percentage of patients,
with the number of patients responding out of the total number of patients who completed follow-up 1 in parentheses. §§The p values of the one-
sided test for superiority were determined with use of the Wilcoxon-Mann-Whitney test (ordinal scale). ##This value was based on the frequency
count of patients with at least one concomitant analgesic therapy during the study.
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98.4% of the enrolled subjects (Fig. 1 and Table II). All partici-
pants providing post-baseline data were included in the analysis
with the last value carried forward to replace missing values and
the predefined adjustment of the VAS score in cases of interfering
concomitant analgesic therapy (see Appendix).
The superiority of extracorporeal shock wave therapy
compared with a placebo in chronic plantar fasciitis was confirmed
to be proven for both primary outcome measures. The median
composite score of heel pain (VAS) was reduced by 69.2% in the
extracorporeal shock wave therapy group compared with 34.5% in
the control group (p =0.0027, one-sided). Furthermore, the dif-
ference in the Roles and Maudsley score was 0.4 point in favor of
extracorporeal shock wave therapy (p =0.0006, one-sided).
Secondary Outcome Measures
Secondary outcome measures are displayed in Table III. The
combined overall result of the eight secondary criteria showed
significance (p =0.0015, one-sided) in favor of extracorporeal
shock wave therapy. Five single secondary criteria showed sig-
nificance: the investigator’s global judgment of effectiveness (p =
0.0110), the subject’sjudgmentoftherapysatisfaction(p=
0.0021), the Roles and Maudsley success rate (p =0.001), the heel
pain overall success rate (p =0.0035), and the single-VAS success
rate for heel pain while taking the first steps in the morning (p =
0.0136).
To assess the stability of the results, different sensitivity
analyses were performed for the primary efficacy criteria at the
time of follow-up 1: a per-protocol analysis, a supportive analysis
for the intention-to-treat data set without any correction for in-
terfering analgesic therapy, a supportive sensitivity analysis for the
intention-to-treat data set with correction for interfering analgesic
therapy by means of the worst-rank score technique, a sensitivity
analysis for the intention-to-treat data set counting all patients lost
to follow-up as treatment failures, and an analysis of the data set
with the data as available instead of the last value carried forward
to replace missing values. All sensitivity analyses resulted in de-
scriptively significant superiority of extracorporeal shock wave
therapy compared with a placebo (all p values, <0.025). Thus, the
results of the sensitivity analyses provide strong support for the
results of the primary analysis (see Appendix).
One hundred and thirty-seven subjects met the criteria for
treatment success at the time of follow-up 1 (sufficient response),
and the rate of responders was 64.8% for the extracorporeal
shock wave therapy group and 46.3% for the placebo group
(Table III). Of the 137, 124 subjects continued the study in the
follow-up 2 period (seventy-three subjects in the extracorporeal
shock wave therapy group and fifty-one subjects in the placebo
therapy group). At the time of follow-up 2, two subjects in the
extracorporeal shock wave therapy group were lost to follow-up,
and three subjects in the control (placebo) group discontinued
early (one for an administrative reason, one for early recovery,
and one for worsening with an adverse event). In the subpopu-
lation that continued the study after follow-up 1, the percentage
change of the VAS composite score from baseline increased from
284.0% at the time of follow-up 1 to 296.0% at the time of
follow-up 2 in the extracorporeal shock wave therapy group
compared with 284.0% at the time of follow-up 1 to 296.3% at
the time of follow-up 2 in the placebo group. The mean change
of the Roles and Maudsley score from baseline increased from
21.7 to 22.1 in the extracorporeal shock wave therapy group
compared with 21.6 to 21.9 in the placebo group. Furthermore,
the single VAS assessments showed comparable results. Thus, the
successful status of the subjects at the time of follow-up 1 con-
tinued and increased during follow-up 2, confirming stability of
treatment success for at least twelve months. The results of the
analyses of the per-protocol population supported these results.
Tolerability and Safety Criteria
The tolerability of the study therapy was judged as very good or
good in 89.1% (106 of 119) of the extracorporeal shock wave
therapy subjects and in 91.2% (104 of 114) of the placebo subjects
at twelve weeks. All 250 randomized subjects received at least one
treatment and were included in the safety analysis population
(Fig. 1). One hundred and one adverse events occurred prior to
follow-up 1. A total of seventy-seven adverse events were found
in forty-three patients in the extracorporeal shock wave therapy
group. In the placebo group, twenty-four adverse events were
seen in seventeen subjects. The preponderance of adverse events
in the extracorporeal shock wave therapy group was due to
known minor untoward effects of treatment (pain and/or dis-
comfort during treatment, pain after treatment, and swelling);
there were sixty-five such adverse events in thirty-four of 126
subjects in the extracorporeal shock wave therapy group and
eleven such adverse events in seven of 124 subjects in the placebo
group, with a rate difference of 21.4%). There were no other
device-related adverse events and no group differences regarding
the remaining adverse events that have been considered to not be
related to treatment (twelve events in eleven subjects in the ex-
tracorporeal shock wave therapy group and thirteen events in
eleven subjects in the placebo group).
Discussion
Extracorporeal shock wave therapy for plantar fasciitis has
been investigated in multiple randomized controlled trials,
providing evidence of effectiveness and safety
7,12,18,19,22,26
. However,
previous studies on extracorporeal shock wave therapy also dem-
onstrated a significant influence of treatment protocols on
outcome
17,18,20,21
. Double-blind randomized controlled trials di-
recting shock waves to anatomical landmarks rather than to the
point of greatest tenderness, using lower energy levels or using
local analgesia, failed to show superiorityof extracorporeal shock
wave therapy over a placebo
11,13,14
. A randomized controlled trial
has demonstrated that local anesthesia significantly reduces the
effectiveness of extracorporeal shock wave therapy
18
, which may
be explained by the inhibition of hyperstimulation, modification
of the gate-control mechanism, and modification of pain medi-
ators
3,13,16,27,28
. Because effectiveness of extracorporeal shock wave
therapy is dependent on treatment parameters, pooling of data in
systematic reviews is inadequate. Effectiveness should be analyzed
individually for specific devices and treatment protocols.
At the primary end point, 98.4% of subjects were available
for analyses, and all sensitivity analyses supported the final results.
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EXTRACORPOREA L SHOCK WAVE THERAPY FOR PLANTAR FASCIITIS
The present study confirmed both significant and clinically rele-
vant
29
superiority of extracorporeal shock wave therapy compared
with the placebo, with a between-group difference of nearly 35%
pain reduction. The relevant superiority of extracorporeal shock
wave therapy was strongly supported by sensitivity analyses as well
as secondary outcome measures. The rate of responders who
continued the study after the twelve-week follow-up was 64.8% in
the extracorporeal shock wave therapy group compared with
46.3% in the placebo group. Although a relevant number of
participants did not reach the criteria for success, a clinically
relevant superiority of extracorporeal shock wave therapy com-
pared with the placebo was demonstrated; for example, the Roles
and Maudsley success rate was 60.8% for the extracorporeal shock
wave therapy group compared with 37.2% for the placebo group.
Furthermore, the assessment of treatment responders demon-
strated stability of treatment success for at least one year; the study
design did not follow the nonresponders of both groups after the
twelve-week follow-up.
Finally, the mean VAS score improvement of >30% in the
placebo group confirms the power of the placebo effect in pain
studies
1-4,7,8,12,15,22
and emphasizes the effectiveness of blinding in
the present study.
In conclusion, focused extracorporeal shock wave ther-
apy applied in weekly interventions (totaling 3 ·2000 impulses,
0.25 mJ/mm
2
) without local analgesia demonstrated relevant
clinical effectiveness in the treatment of chronic plantar fasciitis.
Appendix
Tables showing inclusion and exclusion criteria, time
gaps and correction methods for interfering concomitant
analgesic therapy, and results of the sensitivity analyses re-
garding the a priori-ordered primary efficacy criteria are avail-
able with the online version of this article as a data supplement
at jbjs.org. n
Hans Gollwitzer, MD
Ingo J. Banke, MD
Rainer Burgkart, MD
Clinic of Orthopedics and Sports Orthopedics,
Klinikum Rechts der Isar,
Technische Universit¨
at M¨
unchen,
Ismaninger Strasse 22,
81675 Munich, Germany.
E-mail address for H. Gollwitzer: info@drgollwitzer.de
Amol Saxena, DPM
Palo Alto Medical Foundation,
795 El Camino Real,
Palo Alto, CA 94301
Lawrence A. DiDomenico, DPM
Regional Referral Center,
Northside Medical Center,
500 Gypsy Lane,
Youngstown, OH 44505
Louis Galli, DPM
Advanced Footcare Specialists,
25 Central Park West, Suite 1R,
New York, NY 10023
Richard T. Bouch´
e, DPM
The Sports Medicine Clinic,
10330 Meridian Avenue North, Suite 300,
Seattle, WA 98133
David S. Caminear, DPM
Connecticut Orthopaedic Specialists,
2408 Whitney Avenue,
Hamden, CT 06518
Brian Fullem, DPM
Elite Sports Podiatry,
1700 North McMullen Booth Road, Suite C-2,
Clearwater, FL 33759
Johannes C. Vester
Biometrics in Medicine,
idv-Data Analysis and Study Planning,
Wessobrunner Strasse 6,
82131 Gauting, Germany
Carsten Horn, MD
Unfallchirurgie und Orthop¨
adie,
Klinikum Dachau,
Krankenhausstrasse 15,
85221 Dachau, Germany
Ludger Gerdesmeyer, MD
Klinik f¨
ur Orthop¨
adie und Unfallchirurgie,
Universit¨
atsklinikum Schleswig Holstein,
Arnold Heller Strasse,
24105 Kiel, Germany
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EXTRACORPOREA L SHOCK WAVE THERAPY FOR PLANTAR FASCIITIS
