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Invited Review
Efficacy and safety of extracorporeal shock wave
therapy for orthopedic conditions: a systematic
review on studies listed in the PEDro database
Christoph Schmitz†,*, Nikolaus B. M. Császár†, Stefan Milz†,
Matthias Schieker‡, Nicola Maffulli§,¶, Jan-Dirk Rompe||, and John P. Furia††
†
Extracorporeal Shock Wave Research Unit, Department of Anatomy II, Ludwig-Maximilians-University of
Munich, Pettenkoferstr. 11, Munich 80336, Germany,
‡
Department of Surgery, Experimental Surgery and
Regenerative Medicine, Ludwig-Maximilians-University of Munich, Nussbaumstr. 20, Munich 80336,
Germany,
§
Department of Musculoskeletal Disorders, University of Salerno School of Medicine, Salerno,
Italy,
¶
Queen Mary University of London, Centre for Sports and Excercise Medicine, Mile End Hospital,
Mann Ward, 275 Bancroft Road, London E1 4DG, UK,
||
OrthoTrauma Evaluation Institute, Oppenheimer
Str. 70, Mainz 55130, Germany, and
††
SUN Orthopaedics and Sports Medicine, Division of Evangelical
Community Hospital, 900 Buffalo Road, Lewisburg, PA 17837, USA
*Correspondence address. E-mail: christoph_schmitz@med.uni-muenchen.de
Accepted 12 October 2015
Abstract
Background: Extracorporeal shock wave therapy (ESWT) is an effective and safe non-
invasive treatment option for tendon and other pathologies of the musculoskeletal system.
Sources of data: This systematic review used data derived from the Physiotherapy Evidence
Database (PEDro; www.pedro.org.au, 23 October 2015, date last accessed).
Areas of agreement: ESWT is effective and safe. An optimum treatment protocol for ESWT
appears to be three treatment sessions at 1-week intervals, with 2000 impulses per session
and the highest energy flux density the patient can tolerate.
Areas of controversy: The distinction between radial ESWT as ‘low-energy ESWT’and
focused ESWT as ‘high-energy ESWT’is not correct and should be abandoned.
Growing points: There is no scientific evidence in favour of either radial ESWT or focused
ESWT with respect to treatment outcome.
Areas timely for developing research: Future randomized controlled trials should primarily
address systematic tests of the aforementioned optimum treatment protocol and direct
comparisons between radial and focused ESWT.
British Medical Bulletin, 2015, 1–24
doi: 10.1093/bmb/ldv047
© The Author 2015. Published by Oxford University Press.This is an Open Access article distributed under the terms of the Creative Commons Attribution
Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/), which permits non-commercial re-use, distribution, and reproduction in any
medium, provided the original work is properly cited. For commercial re-use, please contact journals.permissions@oup.com
British Medical Bulletin Advance Access published November 18, 2015
by guest on December 10, 2015http://bmb.oxfordjournals.org/Downloaded from
Key words: ESWT, RSWT, PEDRo, musculoskeletal system
Introduction
Extracorporeal shock wave therapy (ESWT) has been
successfully used for over 20 years to manage a variety
of orthopedic conditions.
1–3
A byproduct of extracor-
poreal shock wave lithotripsy (ESWL), ESWT has
emerged as an acceptable and popular non-invasive
management option for tendon and other pathologies
of the musculoskeletal system. Prior studies on tendino-
pathy showed that ESWT can be as or more effective
than other forms of treatment including eccentric
exercise, traditional physiotherapy, steroid injections,
injections of platelet-rich plasma and surgery.
4–7
One of the primary reasons for the underuse of
ESWT is a generalized unfamiliarity with the tech-
nique. Prior systematic reviews support the widely
accepted notion that ESWT is safe, technically easy
to perform and helpful in some conditions.
2,3,8
That
said, many of these reviews are dated and have also
added to the already pre-existing confusion regard-
ing terminology, protocols, energy levels and treat-
ment parameters. The studies that form the basis of
these reviews differ greatly in regards to design, proto-
col, application technique and length of follow-up.
This heterogeneity makes it difficult for the practi-
tioner to adopt a ‘best practice’approach.
Yet there is no shortage in information. A search
in PubMed on ‘shockwave OR shockwaves OR shock
wave OR shock waves OR shock-wave OR shock-
waves NOT urol* NOT stone NOT stones’on May
17, 2015 yielded over 5000 citations. For this and the
above-mentioned reasons, there remains a need for a
concise summary of the evidence for the use of ESWT
in clinical practice, as well as for developing a gener-
ally applicable ‘best practice’protocol for ESWT.
The PEDro database (www.pedro.org.au,23
October 2015, date last accessed) is a freely available
database of over 31 000 randomized controlled trials
(RCTs), systematic reviews and clinical practice guide-
lines in physical and rehabilitation medicine. For each
RCT, review or guideline, the PEDro database pro-
vides the citation details, the abstract and a link to the
full text, where possible. All RCTs listed in the PEDro
database (henceforth referred to as ‘RCTs in PEDro’)
are independently assessed for quality (the assessment
criteria are summarized in Table 1). All but two of the
PEDro scale items are based on the Delphi list.
9
PEDro is currently the largest independent database
on topics related to physical and rehabilitation medi-
cine and is often used by investigators in Norway,
Australia and New Zealand; less so by other Euro-
pean and North American investigators.
The present systematic review used data derived
from the PEDro database according to the PRISMA
(Preferred Reporting Items for Systematic Reviews
and Meta-Analyses) guidelines
10
to compare (i) ESWT
with other non-operative treatment for tendon and
other pathologies of the musculoskeletal system, (ii)
radial ESWT with focused ESWT (see Figs. 1and 2)
and (iii) high-energy ESWT with low-energy ESWT.
Materials and methods
An evidence-based systematic review of literature
was performed according to the PRISMA (Preferred
Reporting Items for Systematic Reviews and Meta-
Analyses) guidelines
10
to examine efficacy and safety
of ESWT for orthopedic conditions.
Data source
The PEDro database (www.pedro.org.au, 23 October
2015, date last accessed) was searched from its date of
inception to May 17, 2015 to find potentially relevant
publications.
Study selection
Afirst search addressed the key terms shock wave,
shock waves, shockwave, shockwaves, lithotrypsy
and lithotrypter. Based on the outcome of the first
search (as outlined in detail in the next paragraph),
a second search was performed on the key terms
plantar, Achilles, epicondylitis, subacromial, non-
calcific and calcifying.
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Data extraction
The outcome of the first search is shown in Figure 3.
We identified n= 209 records in the PEDro database
of which n= 47 were duplicates. All reviews (n=48)
were excluded, as well as records that did not
address ESWT (n= 3).
13–15
Furthermore, all ESWT
studies on wound healing and chronic decubitus
were excluded (n=5).
16–20
The remaining records
(n=106) were divided into studies on (i) radial
ESWT with positive outcome (i.e. radial ESWT sig-
nificantly better statistically than either placebo or
alternative treatment modalities) (rESWT+; n= 23),
(ii) radial ESWT with negative outcome (i.e. radial
ESWT not significantly better statistically than
either placebo or alternative treatment modalities)
(rESWT−;n= 3), (iii) focused ESWT with positive
outcome (fESWT+; n= 66) and (iv) focused ESWT
with negative outcome (fESWT−;n= 15) (note that
one RCT
12
addressed both radial and focused ESWT
and, thus, was listed in both groups rESWT+ and
fESWT+).
For each of these groups (i.e. rESWT+, rESWT−,
fESWT+ and fESWT−), mean and standard error
of the mean (SEM) of the following variables were
calculated: (i) number of treatment sessions; (ii)
interval between treatment sessions for those RCTs
with more than one treatment session; (iii) number
of impulses per treatment session; (iv) energy flux
density (EFD) of the impulses; (v) total EFD that was
applied (calculated as the product of the number of
treatment sessions, the number of impulses per treat-
ment session and the EFD of the impulses) and (vi)
PEDro score (between 0 and 10). Comparison of
groups was performed using Kruskal–Wallis test
(non-parametric analysis of variance) followed
by pairwise comparisons using Dunn’s multiple
Table 1 Assessment criteria of the PEDro database (modified from www.pedro.org.au, 23 October 2015, date last
accessed)
Part 1: Criteria for inclusion of clinical trials in PEDro (all criteria must be fulfilled)
•The trial must involve comparison of at least two interventions. One of these interventions could be a no treatment control
or a sham treatment.
•At least one of the interventions being evaluated must be currently part of physiotherapy practice or couldbecome part of
physiotherapy practice. However, the study need not be carried out by physiotherapists.
•The interventions should be applied to subjects who are representative (or who are intended to be representative) of those
to whom the intervention might be applied in the course of physiotherapy practice.
•The trial should involve random allocation or intended-to-be-random allocation of subjects to interventions.
•The paper must be a full paper (not an abstract) in a peer-reviewed journal.
Part 2: Assessment criteria of clinical trials included in PEDro
No. Assessment criterion
1
a
Eligibility criteria were specified.
2 Subjects were randomly allocated to groups.
3 Allocation was concealed.
4 The groups were similarat baseline regarding the most important prognostic indicators.
5 There was blinding of all subjects.
6 There was blinding of all therapists who administered the therapy.
7 There was blinding of all assessors whomeasured at least one key outcome.
8 Measures of at least one key outcome were obtained from >85% of the subjects initially allocated to groups.
9 All subjects for whom outcome measures were available received the treatment or control condition as allocated or,
where this was not the case, data for at least one key outcome were analysed by ‘intention to treat’.
10 The results of between-group statistical comparisons are reported forat least one keyoutcome.
11 The study provides both point measures and measures of variability for at least one key outcome.
a
This criterion influences external validity, but not the internal or statistical validity of the trial. It has been included in the PEDro scale so that all
items of the Delphi scale
9
are represented on the PEDro scale. This item is not used to calculatethe PEDro score.
Efficacy and safety of extracorporeal shock wave therapy for orthopedic conditions, 2015 3
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comparison test. Many RCTs in PEDro did not
specify whether the reported EFD was the positive
EFD (EFD
+
) or the total EFD (EFD
total
) (details about
EFD
+
and EFD
total
are provided in Refs.
21,22
). Accord-
ingly, calculations of mean EFDs were based on mixed
EFD
+
and EFD
total
data.
Furthermore, absolute and relative numbers of
studies performed with, respectively, electrohydrau-
lic, electromagnetic or piezoelectric shock wave
generators were calculated. This was done separately
for the groups fESWT+ and fESWT−. Comparison
of groups was performed using χ
2
test.
All calculations were performed with GraphPad
Prism (version 5.00 for Windows; GraphPad Soft-
ware, San Diego, CA, USA). A P-value of <0.05 was
considered statistically significant.
Finally, we investigated which orthopedic condi-
tions were repeatedly (i.e. more than two times)
addressed in the retrieved RCTs on ESWT in PEDro.
This was the case for the indications plantar fascio-
pathy, Achilles tendinopathy, lateral epicondylitis,
subacromial pain syndrome, non-calcific supraspina-
tus tendinopathy and calcifying tendonitis of the
shoulder. On this basis, a second search in the
PEDro database was performed. For each of the key
terms plantar, Achilles, epicondylitis, subacromial,
non-calcific and calcifying, we calculated (i) the total
number of records, the number of reviews and the
number of RCTs in PEDro, (ii) the number of RCTs
in PEDro that addressed the corresponding condi-
tion and (iii) the number of RCTs on ESWT in
PEDro for the corresponding condition. Full-text
articles were not assessed for eligibility during the
second search.
Results
All studies included in the qualitative synthesis of the
first literature search are listed in Tables 2and 3. The
average number of treatment sessions among all
RCTs on ESWT in PEDro was 2.88 ± 0.15 (mean ±
SEM; range: 1–12), with highest numbers in RCTs
on rESWT+ and lowest numbers in RCTs on fESWT+
(Fig. 4A). The difference in the mean number of
treatment sessions between these two groups was
statistically significant (P<0.01).
Fig. 1 Working principle of focused and radial extracorporeal shock wave technology. In case of focused shock waves,
single acoustic pulses are generated either with a spark-gap (electrohydraulic principle), a technology similar to a
loudspeaker (electromagnetic principle) or piezocrystals ( piezoelectric principle) (details are provided in Fig. 2). By means
of reflectors of certain shape, the acoustic pulses are converted into a focused acoustic pressure wave/shock wave with a
point of highest pressure at the desired target within pathological tissue. In case of radial shock waves, a projectile is fired
within a guiding tube that strikes a metal applicator placed on the skin. The projectile generates stress waves in the
applicator that transmit pressure waves into tissue. It is of note that any disturbance in the pathway of the acoustic pulses
between a focused shock wave source and the target within tissue (such as bone, calcifications, etc.; grey dots in the
figures) may result in some parts of the acoustic pulse not reaching the target and, thus, weakening the shock wave energy
(i.e. the energy flux density) at the target. The same disturbances would not impact the energy of radial shock waves at the
target. This is most probably the reason why in muscle tissue, the energy of focused shock waves was found to be
decreased by >50% compared with measurements in water, whereas for radial shock waves, measurements in muscle
tissue and water were consistent.
11
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Among those RCTs on ESWT in PEDro with more
than one treatment session, the average interval
between treatment sessions was 9.13 ± 0.66 days
(range: 1–42 days). On average, the longest intervals
between treatment sessions were reported for Group
fESWT−and the shortest intervals for Group rESWT
−. However, there were no statistically significant
(P< 0.05) differences between the groups (Fig. 4B).
The average number of impulses per treatment
session among all RCTs on ESWT in PEDro varied
only slightly among the groups rESWT+, rESWT−,
fESWT+ and fESWT−, with a mean value of
2029 ± 96 (range: 250–6000). There were no statis-
tically significant (P< 0.05) differences between the
groups (Fig. 4C).
The EFD of the impulses applied in all RCTs on
ESWT in PEDro was on average 0.19 ± 0.01 mJ/mm
2
(range: 0.03–0.78), with the highest mean value in
Group fESWT+ and the lowest mean value in Group
rESWT+ (Fig. 4D). The difference in the mean EFD
Fig. 2 Schematic representation of the mode of operation of focused (A–C) and radial (D) extracorporeal shock wave generators.
(A) Electrohydraulic principle ( fESWT): a high voltage discharges rapidly across two electrode tips (spark-gap) (1) that are
positioned in water. The spark-gap serves as the first focal point (1). The heat generated by this process vaporizes the
surrounding water. This generates a gas bubble centered on the first focal point, with the gas bubble being filled with water
vapor and plasma. The result of the very rapid expansion of this bubble is a sonic pulse, and the subsequent implosion of this
bubble causes a reverse pulse, manifesting a shock wave. By means of reflectors of certain shape (2), this shock wave can be
converted into a convergent/focused acoustic pressure wave/shock wave with a point of highest pressure at the second focal
point (3). (B) Electromagnetic principle (fESWT): a strong, variable magnetic field is generated by passing a high electric current
through a coil (4). This causes a high current in an opposed metal membrane (5), which causes an adjacent membrane (6) with
surrounding liquid to be forced rapidly away. Because the adjacent membrane is highly conductive, it is forced away so rapidly
that the compression of the surrounding liquid generates a shock wave within the liquid. By means of an acoustic lens (7)of
certain shape, this shock wave can be converted into a convergent/focused acoustic pressure wave/shock wave with a point of
highest pressure at a focal point (8). (C) Piezoelectric principle ( fESWT): a large number of piezocrystals (9) are mounted in a
bowl-shaped device (10); the number of piezocrystals can vary from a few to several thousands (typically between 1000 and
2000). When applying a rapid electrical discharge, the piezocrystals react with a deformation (contraction and expansion), which
is known as the piezoelectric effect. This induces an acoustic pressure puls in the surrounding water that can steep into a shock
wave. Because of the design of the bowl-shaped device an acoustic pressure wave/shock wave can emerge with a point of
highest pressure at a focal point (11). (D) Ballistic principle (rESWT): compressed air ( pneumatic principle; 12) or a magnetic
field (not shown) is used to fire a projectile (13) within a guiding tube (14) that strikes a metal applicator (15) placed on the
patient’s skin. The projectile generates stress waves in the applicator that transmit pressure waves into tissue (16).
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between these two groups was statistically significant
(P< 0.01). However, one cannot exclude that this
resulted from the fact that for many RCTs in Groups
fESWT+ and fESWT−, it remained unclear whether
the reported EFD was EFD
+
or EFD
total
(which is
higher than EFD
+
; c.f. Refs.
21,22
). In contrast, for
most studies in Groups rESWT+ and rESWT−,itwas
known that the reported EFD was EFD
+
.
Among all RCTs on ESWT in PEDro, the average
total EFD applied (calculated as the product of
the number of treatment sessions, the number of
impulses per treatment session and the EFD of
Fig. 3 Systematic review flow chart of the first literature search according to the PRISMA (Preferred Reporting Items
for Systematic Reviews and Meta-Analyses) guidelines.
10
*, one study
12
addressed both radial and focused ESWT
and, thus, was listed in both categories rESWT+ and fESWT+.
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Table 2 RCTs on radial ESWT listed in the PEDro database included in the present systematic review
Ps Indication Study O Device T EFD SIImpulses PEDro assessment criteria
234567891011
9 Calcifying tendonitis
of the shoulder
Cacchio et al.
23
+ Not specified
(Elettronica
Pagani)
R 0.10 (EFD
+
) 4 7 2500 ++++−++++ +
Plantar fasciopathy Gerdesmeyer
et al.
24
+ DolorClast (EMS) R 0.16 (EFD
+
) 3 14 2000 ++++−++++ +
Ibrahim et al.
25
+ DolorClast (EMS) R 0.16 (EFD
+
) 2 7 2000 ++++−++++ +
8 Achilles
tendinopathy
Rompe et al.
26
+ DolorClast (EMS) R 0.10 (EFD
+
) 3 7 2000 + + + −−++++ +
Rompe et al.
27
+ DolorClast (EMS) R 0.12 (EFD
+
) 3 7 2000 + + + −−++++ +
Rompe et al.
5
+ DolorClast (EMS) R 0.10 (EFD
+
) 3 7 2000 + + + −−++++ +
Plantar fasciopathy Rompe et al.
28
−DolorClast (EMS) R 0.16 (EFD
+
) 3 7 2000 + + + −−++++ +
Lohrer et al.
12
+ Duolith SD 1 radial
part (Storz)
R 0.17 (EFD
total
) 3 7 2000 + −++−++++ +
Proximal hamstring
tendinopathy
Cacchio et al.
29
+ DolorClast (EMS) R 0.18 (EFD
+
) 4 7 2500 + + + −−++++ +
Subacromial pain Engebretsen
et al.
30
−DolorClast (EMS) R 0.1–0.16 (EFD
+
)4–6 7 2000 −−
7 Calcifying tendonitis
of the shoulder
Kolk et al.
31
−DolorClast (EMS) R 0.11 (EFD
+
) 3 12 2000 ++++−−−++ +
Subacromial pain Engebretsen
et al.
32
−DolorClast (EMS) R 0.1–0.16 (EFD
+
) 3 5 2000 + + + −−−+++ +
Lateral epicondylitis Gündüz et al.
33
+ Not specified R ‘1.4 bar’10 1 500 + + + −−++−++
Plantar fasciopathy Chow and
Cheing
34
+ DolorClast (EMS) R 0.05 to max.
tolerable EFD
+
3 7 1000 + −++−++−++
6 Plantar fasciopathy Shaheen
35
+ DolorClast (EMS) R 0.06–0.14 (EFD
+
) 3 7 2000 + −++−+−−++
5 Non-specific
shoulder pain
Damian and
Zalpour
36
+ Masterpuls MP 200
(Storz)
R Not specified 5.5 7 ? + −+−−−+−++
Primary long
bicipital
tenosynovitis
Liu et al.
37
+ DolorClast (EMS) R 0.12 (EFD
+
) 4 7 1500 + −+−−−+−++
Cho et al.
38
+ R 0.12 (?) 1 1000 + −+−−−+−++
Table continues
Efficacy and safety of extracorporeal shock wave therapy for orthopedic conditions, 2015 7
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Table 2 Continued
Ps Indication Study O Device T EFD SIImpulses PEDro assessment criteria
234567891011
Myofascial pain
syndrome
JEST-2000
(Joeunmedical,
Korea)
Lateral epicondylitis Sarkar et al.
39
+ Masterpuls MP 100
(Storz)
R 0.06 (?) 3 7 2000 + −+−−−+−++
Lateral and medial
epicondylitis
Lee et al.
6
+ DolorClast (EMS) R 0.06–0.12 (EFD
+
) 3 7 2000 + −+−−−+−++
Greater trochanteric
pain syndrome
Rompe et al.
40
+ DolorClast (EMS) R 0.12 (EFD
+
) 3 7 2000 −−+−−−+++ +
Plantar fasciopathy Grecco et al.
41
+ DolorClast (EMS) R 0.12 (EFD
+
) 3 7 2000 + −+−−−+−++
Greve et al.
42
+ DolorClast (EMS) R 0.12 (EFD
+
) 3 7 2000 + −+−−−+−++
Marks et al.
43
−DolorClast (EMS) R 0.16 (EFD
+
) 3 3 2000 + −+−−++−− +
4 Plantar fasciopathy
and tennis elbow
Mehra et al.
44
+ DolorClast (EMS) R 0.10 (EFD
+
) 3 14 2000 + −−−−−+−++
Spasticity Vidal et al.
45
+ DolorClast (EMS) R 0.10 (EFD
+
) 3 7 2000 + −−−−+−−++
Ps, PEDro score; O, outcome; +, rESWT significantly better statistically than either placebo or alternative treatment modalities; −, rESWT not significantly better statistically than either placebo or
alternative treatment modalities; T, shock wave technology; R, radial; EFD, energy flux density; EFD
+
, positive EFD; EFD
total
, total EFD; (?), not specified whether EFD
+
or EFD
total
;S, number of
treatment sessions; I, interval between treatment sessions (days). The PEDro assessment criteria 2–11 are outlined in detail in Table 1. Note that the first PEDro assessment criterion (Eligibility criteria
were specified) is not used to calculate the PEDro score.
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Table 3 RCTs on focused ESWT listed in the PEDro database included in the present systematic review
Ps Indication Study O Device T EFD SI Impulses PEDro assessment criteria
234567891011
9 Calcifying tendonitis
of the shoulder
Gerdesmeyer et al.
46
+ Epos Ultra (Dornier) EM 0.08–0.32 (?) 2 14 1500 or 6000 + + + + −++++ +
Lateral epicondylitis Rompe et al.
47
+ Sonocur Plus
(Siemens)
EM 0.09 (EFD
total
) 3 7 2000 + + + + −++++ +
Pettrone and McCall
48
+ Sonocur Plus
(Siemens)
EM 0.06 (?) 3 7 2000 + + + + −++++ +
Patellar
tendinopathy
Zwerver et al.
49
−Piezowave (Wolf) PE 0.068–0.40
(EFD
+
)
3 7 2000 + + + + −++++ +
Achilles
tendinopathy
Rasmussen et al.
50
+ Piezoson 100 (Wolf) PE 0.12–0.51 (?) 3 7–14 2000 + + + + −++++ +
Plantar fasciopathy Buchbinder et al.
51
−Epos Ultra (Dornier) EM 0.02–0.33 (?) 3 7 2000 or 2500 + + + + −++++ +
Kudo et al.
52
+ Epos Ultra (Dornier) EM 0.36 (EFD
+
) 1 3500 + + + + −++++ +
Gollwitzer et al.
53
+ Duolith SD 1 (Storz) EM 0.25 (EFD
total
) 3 7 2000 + + + + −++++ +
8 Calcifying tendonitis
of the shoulder
Schmitt et al.
54
−Minilith SL 1 (Storz) EM 0.11 (EFD
+
) 3 7 2000 + + + + −++−++
Haake et al.
55
+ Minilith SL 1 (Storz) EM 0.78 (EFD
total
) 2 7 2000 + + + + −++−++
Ioppolo et al.
56
+ Modulith SLK (Storz) EM 0.10 and 0.20 (?) 4 7 2400 + + + −−++++ +
Albert et al.
57
+ Modulith SLK (Storz) EM 0.45 (?) 2 14 2500 + −++−++++ +
Lateral epicondylitis Speed et al.
58
−Sonocur Plus
(Siemens)
EM 0.18 (?) 3 28 1500 + −++−++++ +
Staples et al.
59
−MedTech Epos
(Dornier)
EM Maximum
tolerable
3 7 2000 + −++−++++ +
Haake et al.
60
−Various devices EM/PE 0.04–0.22
(EFD
+
)
3 7 2000 + + −+−++++ +
Chung and Wiley
61
−Sonocur Basic
(Siemens)
EM 0.03–0.17 (?) 3 7 2000 + + + −−++++ +
Plantar fasciopathy Buch et al.
62
+ Epos Ultra (Dornier) EM 0.03–0.36 (?) 1 3800 + + + + −++−++
Haake et al.
63
−Epos Ultra (Dornier) EM 0.08 (EFD
+
) 3 14 4000 + −++−++++ +
Speed et al.
64
−Sonocur Plus
(Siemens)
EM 0.12 (?) 3 28 1500 + −++−++++ +
Lohrer et al.
12
+ Duolith SD 1 (Storz) EM 0.20 (EFD
total
) 3 7 2000 + −++−++++ +
Table continues
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Table 3 Continued
Ps Indication Study O Device T EFD SI Impulses PEDro assessment criteria
234567891011
7 Calcifying tendonitis
of the shoulder
Peters et al.
65
+ Minilith SL 1 (Storz) EM 0.15 and 0.44 (?) 5 42 1500 + + −+−++−++
Hearnden et al.
66
+ Not specified 0.28 (?) 1 2000 + + −+−++−++
Pleiner et al.
67
+ Orthospec
(Medispec)
EH 0.28 (?) 2 14 2000 + −+−+++−++
Tornese et al.
68
+ Epos Ultra (Dornier) EM 0.22 (?) 3 7 1800 + −+−−++++ +
Sabeti-Aschraf et al.
69
+ Modulith SLK (Storz) EM 0.08 (?) 3 7 1000 + + −−−+++ +
0.20 (?) 2 7 2000
Non-calcific
supraspinatus
Haake et al.
70
+ Minilith SL 1 (Storz) EM 0.33 (EFD
+
) 3 7 2000 + −+−−++++ +
tendinopathy Groß et al.
71
−Minilith SL 1 (Storz) EM 0.33 and 0.44
(EFD
+
)
3 7 2000 + −+−−++++ +
Galasso et al.
72
+ Modulith SLK (Storz) EM 0.068 (?) 2 7 3000 + −++−++−++
Plantar fasciopathy Rompe et al.
73
+ Sonocur Plus
(Siemens)
EM 0.16 (?) 3 7 2100 + + + −−++−++
Ogden et al.
74
+ Ossatron (HMT) EH 0.22 (?) 1 1500 + + + + −++−+−
Theodore et al.
75
+ Epos Ultra (Dornier) EM 0.36 (?) 1 3800 + −++−++−++
Porter and Shadbolt
(2005)
76
−Not specified EH 0.08 (?) 3 7 1000 + + + −−++−++
Liang et al.
77
+ Piezoson 100 (Wolf) PE 0.12 and 0.56
(EFD
total
)
3 7 2000 + + + −−++−++
Malay et al.
78
+ Orthospec
(Medispec)
EH Not specified 1 3800 + −++−++−++
Vahdatpour et al.
79
+ Duolith SD 1 (Storz) EM 0.20 (?) 3 7 4000 + −++−−+++ +
Radwan et al.
80
+ Ossatron (HMT) EH 0.22 (?) 1 1500 + + + −−−+++ +
Knee osteoarthritis Chen et al.
81
+ Piezowave (Wolf) PE 0.275 (EFD
+
) 6 7 2000 + + + −−−+++ +
6 Myogelosis of the
masseter muscle
Kraus et al.
82
+ Sonocur Plus
(Siemens)
EM 0.04 (?) 1 250 + −−+−++−++
Calcifying tendonitis
of the shoulder
Pan et al.
83
+ Orthospec
(Medispec)
EH 0.26–0.32 (?) 2 14 2000 + −+−−++−++
Perlick et al.
84
+ Lithostar (Siemens) EM 0.33, 0.42,
0.54 (?)
2 21 2000 + + + −−−+−++
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Sabeti-Aschraf et al.
85
+ Modulith SLK (Storz) EM 0.08 (?) 3 7 1000 + −+−−++−++
Lateral epicondylitis Rompe et al.
86
+ Osteostar (Siemens) EM 0.08 (?) 3 7 1000 + −+−−++−++
Haake et al.
87
Various devices EM/PE 0.04–0.22
(EFD
+
)
3 7 2000 + −++−−+−++
Melikyan et al.
88
−Epos Ultra (Dornier) EM 333 (total EFD
delivered) (?)
3? ? +−++−++−+−
Melegati et al.
89
+ Epos Ultra (Dornier) EM 0.16 (?) 3 7 1800 + −++−−+−++
Long bone fracture Wang et al.
90
+ Ossatron (HMT) EH 0.62 (?) 1 6000 + −+−−++−++
Achilles
tendinopathy
Costa et al.
91
−Modulith SLK (Storz) EM 0.20 (?) 3 28 1500 + + −−−++−++
Plantar fasciopathy Ogden et al.
92
+ Ossatron (HMT) EH 0.22 (?) 1 1500 + −++−++−+−
Rompe et al.
93
+ Osteostar (Siemens) EM 0.08 (?) 3 7 1000 + + −−−−+++ +
Chew et al.
94
+ Epos Ultra (Dornier) EM 0.42 (?) 2 7 2000 + + + −−+−−++
Tornese et al.
95
+ Epos Ultra (Dornier) EM 0.22 (?) 3 7 1800 + −+−−++−++
Saxena et al.
96
+ Duolith SD 1 (Storz) EM 0.24 (EFD
total
) 3 7 2000 + + + −−−+−++
Spasticity El-Shamy et al.
97
+ Modulith SLK (Storz) EM 0.03 (?) 12 7 1500 + + + −−+−−++
5 Calcifying tendonitis
of the shoulder
Cosentino et al.
98
+ Orthima (Direx
Medical) EH
EH 0.28 (?) 4 5.5 1200 + −++−+−−+−
Hsu et al.
99
+ OrthoWave (MTS) EH 0.55 (?) 2 14 1000 −−++−++−+−
Farr et al.
100
+ Modulith SLK (Storz) EM 0.30 (?) 1 3200 + −−−−++−++
0.20 (?) 2 7 1600
Tenonitis of the
rotator cuff
Speed et al.
101
−Sonocur (Siemens) EM 0.12 (?) 3 28 1500 + −+−−−−++ +
Lateral epicondylitis Rompe et al.
102
+ Osteostar (Siemens) EM 0.08 (?) 3 7 1000 + −+−−+−−++
Rompe et al.
103
+ Sonocur (Siemens) EM 0.16 (?) 3 7 1000 −−+−−++−++
Chung et al.
104
−Sonocur Basic
(Siemens)
EM 0.03–0.17 (?) 3 7 2000 + −+−−−+−++
Lateral epicondylitis Ozturan et al.
105
+ Stonelith V5 (PCK) EH 0.17 (?) 3 7 2000 + −+−−−+−++
Patellar
tendinopathy
Wang et al.
106
+ Ossatron (HMT) EH 0.18 (?) 1 1500 −−+++++−++
Plantar fasciopathy Rompe et al.
107
+ Osteostar (Siemens) EM 0.08 (?) 3 7 1000 + + + −−−−−++
Plantar fasciopathy Krischek et al.
108
+ Osteostar (Siemens) EM 0.08 (?) 3 7 500 + −+−−−+−++
Plantar fasciopathy Cosentino et al.
109
+ Orthima (Direx
Medical)
EH Between 0.03
and 0.4 (?)
6 8.5 1200 + −++−−+−+−
Table continues
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Table 3 Continued
Ps Indication Study O Device T EFD SI Impulses PEDro assessment criteria
234567891011
Plantar fasciopathy Hammer et al.
110
+ Piezoson 300 (Wolf) PE 0.20 (?) 3 7 3000 + −+−−−+−++
4 Calcifying tendonitis
of the shoulder
Seil et al.
111
+ Piezolith 2501 (Wolf) PE 0.10 and 0.30 (?) 3 7 5000 + −+−−−+−+−
1 5000
Loew et al.
112
+ MFL 5000 (Philips)
and Compact
(Dornier)
EH 0.10 1 2000 −−+−−−+−++
+ MFL 5000 (Philips)
and Compact
(Dornier)
EM 0.3 1 2000
+ MFL 5000 (Philips)
and Compact
(Dornier)
EM 0.3 2 7 2000
Supraspinatus
tendon syndrome
Schmitt et al.
113
−Minilith SL1 (Storz) EM 0.33 (EFD
+
) 3 7 2000 + −−−−−+−++
Lateral epicondylitis Haake et al.
114
−Minilith SL 1 (Storz) EM 0.22 (EFD
+
) 3 7 2000 −−++−−−−++
Osteonecrosis of the
femoral head
Wang et al.
115
+ Ossatron (HMT) EH 0.62 (?) 1 6000 −−+−−−+−++
Plantar fasciopathy Rompe et al.
116
+ Osteostar (Siemens) EM 0.06 (?) 3 7 1000 + −+−−−−−++
Wang et al.
117
+ Ossatron (HMT) EH 0.32 (?) 1 1500 −−+−−−+−++
Yucel et al.
118
+ Stonelith V5 (PCK) EH Not specified 1 3000 + −+−−−−−++
Hammer et al.
119
+ Piezoson 300
(Richard Wolf)
PE 0.20 (?) 3 7 3000 + −+−−−+−− +
Achilles
tendinopathy
Notarnicola et al.
120
−Minilith SL1 (Storz) EM 0.06 (?) 3 3.5 1600 + −+−−−−−++
3 Calcifying tendonitis
of the shoulder
Rompe et al.
121
+ Not specified
(Siemens)
EM 0.06 and 0.28 (?) 1 1500 + −−−−−−−++
Lateral epicondylitis Crowther et al.
122
+ Minilith SL1 (Storz) EM 0.10 (?) 3 7 2000 + + −−−−−−+−
Lateral epicondylitis Rompe et al.
123
+ Osteostar (Siemens) EM 0.08 (?) 3 7 1000 + −+−−−−−+−
Lateral epicondylitis/
tendinosis
calcarea of the
shoulder
Rompe et al.
124
+ Not specified
(Siemens)
EM 0.08 (?) 3 7 1000 + −−−−−+−− +
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the impulses) was 0.99 ± 0.08 J/mm
2
(range: 0.01–
3.72 J/mm
2
), with the highest mean value in Group
fESWT+ and the lowest mean value in Group
rESWT+. However, there were no statistically signifi-
cant (P< 0.05) differences between the groups
(Fig. 4E).
The average PEDro score among all RCTs on ESWT
in PEDro was 6.33 ± 0.17 (range: 1–9), with the highest
mean score in Group fESWT−and the lowest mean
score in Group fESWT+ (Fig. 4F). The difference in the
meanPEDroscorebetweenthesetwogroupswas
statistically significant (P<0.01).
Furthermore, in 17 RCTs on fESWT with posi-
tive outcome in PEDro, an electrohydraulic (EH)
device was used, in 42 RCTs an electromagnetic
(EM) device and in 6 RCTs a piezoelectric (PE)
device (in 1 RCT both EH and EM device were
used). For the RCTs on fESWT with negative
outcome in PEDro, the corresponding numbers
were 1 (EH), 13 (EM) and 2 (PE) (1 study with both
EH and EM devices). The distribution of numbers
of EH, EM and PE devices was not statistically sig-
nificant (P= 0.229) between RCTs on fESWT with
positive outcome and RCTs on fESWT with nega-
tive outcome.
The results of the second search are summarized
in Table 4. For the key word plantar, 82 out of 288
records (28.5%) in the PEDro database were RCTs
on plantar fasciopathy, of which 41 (41/82 = 50%)
had a PEDro score of 6 or higher. For the other key
words, the corresponding numbers were as follows:
Achilles: 44/130 = 33.8% RCTs on Achilles tendino-
pathy, among them 27/44 = 61.4% with PEDro
score ≥6. Epicondylitis: 106/106 = 100% RCTs on
lateral epicondylitis, among them 48/106 = 45.3%
with PEDro score ≥6. Non-calcific: 3/8 = 37.5%
RCTS on non-calcific supraspinatus tendinopathy,
among them 2/3 = 66.6% with PEDro score ≥6.
Calcifying: 16/21 = 76.2% RCTs on calcifying ten-
donitis of the shoulder, among them 9/16 = 56.3%
with PEDro score ≥6. Subacromial: 63/76 = 82.9%
RCTS on subacromial pain syndrome, among them
40/63 = 63.5% with PEDro score ≥6.
For plantar fasciopathy, 41.5% of the RCTs listed
in the PEDro database were RCTs on ESWT (56.1%
of the RCTs with PEDro score ≥6). For other
1 Rotator cuff lesions Saggini et al.
125
+ Evotron (HMT) EH 0.132 (?) 3 7 600 + −−−−−−−− −
Ps, PEDro score; O, outcome; +, fESWT significantly better statistically than either placebo or alternative treatment modalities; −, fESWT not significantly better statistically than either placebo or
alternative treatment modalities; T, shock wave technology; EH, electrohydraulic; EM, electromagnetic; PE, piezoelectric; EFD, energy flux density; EFD
+
, positive EFD; EFD
total
, total EFD; (?), not
specified whether EFD
+
or EFD
total
;S, number of treatment sessions; I, interval between treatment sessions [days]. The PEDro assessment criteria 2–11 are outlined in detail in Table 1. Note that the
first PEDro assessment criterion (Eligibility criteria were specified) is not used to calculate the PEDro score.
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indications, the corresponding relative numbers of
RCTs on ESWT were as follows: Achilles tendinopa-
thy: 11.4% of all RCTs, and 18.5% of those RCTs
with PEDro score ≥6. Lateral epicondylitis: 15.1% of
all RCTs, and 18.8% of those RCTs with PEDro
score ≥6. Non-calcific supraspinatus tendinopathy:
100% of all RCTs. Calcifying tendonitis of the shoul-
der: 81.3% of all RCTs, and 77.8% of those RCTs
with PEDro score ≥6. Subacromial pain syndrome:
4.8% of all RCTs, and 7.5% of those RCTs with
PEDro score ≥6.
Discussion
Methodological considerations
Prior systematic reviews attempted to assimilate the
raw data from hundreds of studies investigating ESWT
so as to draw meaningful conclusions. Unfortunately,
many of these reviews, by not defining terminology,
and by not drawing a distinction between the various
types of ESWT have at times added to the confusion.
Concepts such as radial ESWT, focused ESWT, low-
energy ESWT and high-energy ESWT have clinical,
practical and economic implications and therefore
need explanation by reviewers.
The reliability of the PEDro scale for rating the
quality of RCTs was demonstrated
126
and subsequently
confirmed independently.
127
Using RCTs derived only
from the PEDro database, we sought to (i) clarify some
common misconceptions regarding ESWT and (ii) for
specific indications, compare ESWT with other forms
of non-operative treatment.
A meta-analysis is often very helpful when the effi-
cacy of an intervention is not known. The preponder-
ance of the RCTs derived from our search of the
PEDro database demonstrated that ESWT is better than
placebo, no treatment or an alternative treatment (>80%
of all studies on ESWT in PEDro). However, there are
substantial differences among RCTs on ESWT listed in
PEDro with regard to clinical condition, study design,
ESWT technology and device, treatment protocol and
follow-up period. Therefore, we felt a clinical review
would be the more appropriate format for our purposes.
We have derived 10 main statements about ESWT
basedontheRCTsonrESWTandfESWTinPEDro
Fig. 4 Mean and standard error of the mean (SEM) of the
number of treatment sessions (A), interval between treatment
sessions (B), number of impulses per treatment session (C),
energy flux density of the impulses (D), total energy flux
density that was applied (E) and the PEDro score of all RCTs on
radial (rESWT) and focused (fESWT) extracorporeal shock wave
therapy with positive (+) or negative (−) outcome listed in the
PEDro database (deadline: May 17, 2015). Details are provided
in the main text.
14 C. Schmitz et al., 2015
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(Table 5). Each statement is briefly substantiated by sci-
entific evidence developed in the present systematic
review. References to studies not listed in PEDro were
kept at the absolute minimum and marked by an aster-
isk.
ESWT is effective
The efficacy of ESWT is clearly supported by the
cumulative data. 88.5% (23 out of 26) of all RCTs
on rESWT and 81.5% (66 out of 81) of all RCTs on
fESWT in PEDro had positive outcome (i.e. rESWT
or fESWT significantly better statistically than either
placebo or alternative treatment modalities).
ESWT is safe
The safety of ESWT was also clearly supported by
the cumulative data. There were no reports of serious
adverse events in any of the studies included in this
analysis.
For certain orthopedic conditions, RCTs on
ESWT were the predominant type of RCT
listed in the PEDro database and/or obtained
the highest PEDro scores among all
investigated treatment modalities
Both criteria (i.e. predominant type of RCT in PEDro,
and highest PEDro scores among all investigated treat-
ment modalities) were fulfilled for the indications
plantar fasciopathy, non-calcific supraspinatus tendi-
nopathy and calcifying tendonitis of the shoulder
(Table 4). For Achilles tendinopathy and lateral epi-
condylitis, respectively, 11.4 and 15.1% of all RCTs
in PEDro were RCTs on ESWT, but these RCTs also
obtained among the highest PEDro scores among all
investigated treatment modalities for these conditions.
For other indications (greater trochanteric pain
syndrome, patellar tendinopathy, knee osteoarthritis,
long bone fracture, osteonecrosis of the femoral head,
proximal hamstring tendinopathy, primary long
bicipital tenosynovitis, myofascial pain syndrome,
Table 4 Results of the second search of the PEDro database split up according to key words as outlined in detail
in the main text (deadline: May 17, 2015)
Plantar Achilles Epicondylitis Non-calcific Calcifying Subacromial
Records 288 130 135 8 21 76
Reviews 42 31 29 3 5 13
RCTs 246 99 106 5 16 63
Ps AB AB A B A B AB AB
10 1 0 2 0 0 n/a 0 n/a 0 0 0 n/a
9 7 71.4 1 100 3 66.7 0 n/a 1 100 4 0
8 9 55.6 5 60.0 9 44.4 0 n/a 3 100 10 10.0
7 13 61.5 11 0 17 5.9 2 100 4 75.0 15 13.3
6 11 45.5 8 12.5 19 10.5 0 n/a 1 0 11 0
5 13 46.2 6 0 24 20.8 1 100 3 100 11 0
4 16 25.0 8 0 14 7.1 0 n/a 3 66.7 7 0
3 8 12.5 3 0 7 14.3 0 n/a 1 100 1 0
2 2 0 0 n/a 3 0 0 n/a 0 n/a 2 0
1 1 0 0 n/a 3 0 0 n/a 0 n/a 0 n/a
CE 1 0 0 n/a 7 0 0 n/a 0 n/a 2 0
Total-1 82 41.5 44 11.4 106 15.1 3100 16 81.3 63 4.8
Total-2 41 56.1 27 18.5 48 18.8 2100 977.8 40 7.5
Records, total number of records; Reviews, number of reviews; RCTs, number of RCTs. Ps, PEDro score; A, absolute number of RCTs
addressing the corresponding indication (i.e. plantar fasciopathy, Achilles tendinopathy, lateral epicondylitis, non-calcific supraspinatus
tendinopathy, calcifying tendonitis of the shoulder and subacromial pain), split up according to PEDro scores; B, relative number of RCTs on
ESWT addressing the corresponding indication; split up according to PEDro scores; CE, currently evaluated by PEDro. Total-1, total and
relative numbers of RCTs in categories A and B; Total-2, total and relative numbers of RCTs in categories A and B with a PEDro score of 6 or
higher.
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myogelosis of the masseter muscle and spasticity),
there are not enough RCTs on rESWT and fESWT
in PEDro to draw meaningful conclusions regarding
the significance of ESWT for the corresponding
conditions.
There was no difference in the ‘quality’
of RCTs on ESWT in PEDro with positive
or negative outcome
RCTs on ESWT with either positive or negative
outcome had almost the same averaged PEDro scores.
This finding contradicts the belief that ‘better’RCTs
(i.e. RCTs with a higher PEDro score) generally dem-
onstrate that ESWT is not effective.
Application of local anesthesia adversely
affects outcome of ESWT
Two studies
128
*
,129
* demonstrated that application
of local anesthesia in the area of treatment (as done
in Refs.
54,63
) adversely affects outcome of ESWT.
The molecular mechanisms underlying this phenom-
enon are not yet fully understood, but substantial
evidence points to a central role of the peripheral
nervous system in mediating molecular and cellular
effects of shock waves applied to the musculoskeletal
system.*
130–132
* These effects could be blocked by
local anesthesia.
133
* Thus, it is now generally recom-
mended to apply shock waves without local anesthe-
sia to the musculoskeletal system.
Application of insufficient energy adversely
affects outcome of ESWT
The averaged EFD applied in all RCTs on rESWT
and fESWT for calcifying tendonitis of the shoulder
with positive outcome in PEDro (‘averaged EFD’)
was 0.28 ± 0.04 mJ/mm
2
. This was ∼2.6 times more
than the EFD applied in a negative RCT on rESWT
for this indication (EFD = 0.11 mJ/mm
2
).
31
A similar
situation was found for treating plantar fasciopa-
thy. Here, the averaged EFD was 0.19 ± 0.02 mJ/
mm
2
, which was more than two times the EFD
applied in a negative RCT on fESWT
63
as well as in
another negative RCT on fESWT
76
(0.08 mJ/mm
2
).
Regarding Achilles tendinopathy, averaged EFD
was equal to 0.17 ± 0.04 mJ/mm
2
in RCTs on
ESWT with positive outcome in PEDro, compared
with EFD = 0.06 mJ/mm
2
applied in an RCT on
fESWT with negative outcome.
120
There is no scientific evidence in favor
of either rESWT or fESWT with respect
to treatment outcome
‘Which is better, rESWT or fESWT?’A review of the
PEDro database demonstrated no scientific evidence
in favor of either rESWT or fESWT with respect to
treatment outcome. There are very few studies com-
paring the two techniques. In one such study,
12
better results were reported with fESWT than with
rESWT for treating patients with plantar fasciopathy
Table 5 Main statements about ESWT based on the RCTs on rESWT and fESWT listed in the PEDro database
No. Statement
1 ESWT is effective.
2 ESWT is safe.
3 For certain orthopedic conditions, RCTs on ESWT were the predominant type of RCT listed in the PEDro database
and/or obtained the highest PEDro scores among all investigated treatment modalities.
4 There was no difference in the ‘quality’of RCTs on ESWT in PEDro with positive or negative outcome.
5 Application of local anesthesia adversely affects outcome of ESWT.
6 Application of insufficient energy adversely affects outcome of ESWT.
7 There is no scientific evidence in favor of either rESWT or fESWT with respect to treatment outcome.
8 The distinction between radial ESWT as ‘low-energy ESWT’and focused ESWT as ‘high-energy ESWT’is not correct
and should be abandoned.
9 There is no scientific evidence that a certain fESWT technology is superior to theother technologies.
10 An optimum treatment protocol for ESWT appears to be three treatment sessions at 1-week intervals, with 2000
impulses per session and the highest energy flux density that can be applied.
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(EFD was higher in fEWST than in rESWT in this
study
12
). However, using the same rESWT and
fESWT devices than in Ref.
12
and the same EFD in
fESWT and rESWT, other authors found no differ-
ence in effectiveness between rESWT and fESWT for
patients with patellar tendinopathy.
134
*
The distinction between radial ESWT
as ‘low-energy ESWT’and focused ESWT
as ‘high-energy ESWT’is not correct
and should be abandoned
Rompe et al.
8
arbitrarily defined an EFD of 0.2 mJ/
mm
2
as the margin between low- and high-energy
shock wave treatments. Following this definition,
100% of the RCTs on rESWT, ∼45% of the fESWT+
RCTs and ∼77% of the fESWT−RCTs in PEDro
were performed with low-energy shock waves (c.f.
Tables 2and 3). However, other definitions of the mar-
gin between low- and high-energy shock wave treat-
ments were published
135
*
,136
*(Table6). Accordingly,
it is not correct to characterize rESWT as low-energy
shock wave treatment and fESWT as high-energy
shock wave treatment, as different authors have used
different thresholds for this distinction. Because there
is no consensus in the literature about the difference
between low- and high-energy ESWT, this distinction
appears arbitrary and should be abandoned.
There is no scientific evidence that a certain
fESWT technology is superior to other
technologies
Focused shock waves can be produced by electrohy-
draulic, electromagnetic and piezoelectric shock wave
generators. In 2001, Ogden et al.
92
in an early review
of ESWT technology stated that ‘the electrohydraulic
method . . .has been shown to be superior to other
generation methods (electromagnetic, piezoelectric)’.
These authors
92
used literature derived from urology
(i.e. from ESWL) to substantiate this claim. However,
we found no statistically significant (P< 0.05) differ-
ence in the distribution of numbers of RCTs on
fESWT in PEDro using electrohydraulic, electromag-
netic and piezoelectric shock wave generators among
studies with positive outcome and studies with nega-
tive outcome. Hence, the RCTs on fESWT in PEDro
do not indicate an advantage of a certain fESWT tech-
nology over other technologies.
An optimum treatment protocol for ESWT
appears to be three treatment sessions at
1-week intervals, with 2000 impulses per
session and the highest EFD that can be
applied
This recommendation is based on the quantitative
analysis shown in Figure 4and reflects the average
number of treatment sessions and the average inter-
val between treatment sessions among all RCTs on
ESWT in PEDro. With respect to the EFD of the
impulses (to be as high as possible, i.e. what can be
tolerated by the individual patient without application
of local anesthesia), this recommendation is based on
findings of one study on rESWT for plantar fasciopa-
thy with positive outcome
34
and another study on
fESWT for calcifying tendonitis of the shoulder with
positive outcome
112
that ‘more is better’. There is not
a single RCT on ESWT in PEDro, contradicting this
‘more is better’recommendation.
Limitations
There are three main limitations inherent to the
present systematic review on ESWT. First, with few
Table 6 Percentage of studies on ESWT listed in the PEDro database that would be considered ‘high-energy
ESWT’according to different definitions of the margin between low- and high-energy shock wave treatments in
the literature
References Margin [mJ/mm
2
] rESWT+ (%) rESWT−(%) fESWT+ (%) fESWT−(%)
Rompe et al.
8
0.20 0 0 54.7 23.1
Neufeld and Cerrato
135
* 0.12 57.1 66.6 73.4 61.5
Lei et al.
136
* 0.10 90.5 100 78.1 76.9
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exceptions, only RCTs on ESWT in PEDro were con-
sidered. This approach was adopted to minimize
selection bias by using the selection process and cri-
teria of an independent third party that has never
been involved in planning, performing and funding
any study on ESWT, and to rely on the proven reli-
ability of the PEDro scale for rating the quality of
RCTs. Accordingly, all analyses, interpretations and
conclusions of the present study are only valid for
those RCTs on ESWT in PEDro.
Second,nometa-analysiswasperformed.Thiswas
because of the substantial differences among RCTs on
ESWT in PEDro with regard to clinical condition,
study design, ESWT technology and device, treatment
protocol and follow-up period.
Third, because of the first and second limitations,
all conclusions of the present study are only valid for
those shock wave generators that were used in the
RCTs on ESWT in PEDro (Tables 2and 3). This is
particularly important considering the substantial
variability in treatment success and rates of unwanted
side effects found when treating the same clinical con-
dition (lateral epicondylitis) with different electromag-
netic and piezoelectric fESWT devices operated at
comparable energy settings.
60,87
Conclusion
ESWT has been proven as effective and safe non-
invasive treatment option for tendon and other path-
ologies of the musculoskeletal system in a multitude
of high-quality RCTs. For plantar fasciopathy, non-
calcific tendinopathy of the supraspinatus tendon
and calcifying tendonitis of the shoulder RCTs on
ESWT are the predominant type of RCT in PEDro
and obtained the highest PEDro scores among all
investigated treatment modalities for these condi-
tions. The latter criterion was also achieved for Achil-
les tendinopathy and lateral epicondylitis, albeit in a
smaller number of RCTs. Therefore, ESWT should be
considered by medical doctors, therapists, patients and
payers when discussing treatment options for certain
musculoskeletal pathologies. Future RCTs on ESWT
should primarily address systematic tests of the
optimum treatment protocol identified in this sys-
tematic review (three treatment sessions at 1-week
intervals, with 2000 impulses per session and the
highest EFD that can be applied) and direct compari-
sons between radial and focused ESWT.
Conflict of interest statement
N.B.M.C., S.M., M.S., J.-D.R. and J.P.F. declare that
no competing financial interests exist. C.S. serves
as a paid consultant for and receives benefits from
Electro Medical Systems (Nyon, Switzerland), the
manufacturer and distributor of the Swiss Dolor-
Clast radial shock wave device. However, C.S. has
not received any honoraria or consultancy fee in
writing this manuscript. No other potential conflicts
of interest relevant to this article were reported.
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