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Efficacy and safety of extracorporeal shock wave therapy for orthopedic conditions: A systematic review on studies listed in the PEDro database

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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.
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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Invited Review
Efcacy 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 ux density the patient can tolerate.
Areas of controversy: The distinction between radial ESWT as low-energy ESWTand
focused ESWT as high-energy ESWTis not correct and should be abandoned.
Growing points: There is no scientic 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, 124
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.
13
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.
47
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 difcult for the practi-
tioner to adopt a best practiceapproach.
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 stoneson 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 practiceprotocol 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 efcacy 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 nd potentially relevant
publications.
Study selection
Arst search addressed the key terms shock wave,
shock waves, shockwave, shockwaves, lithotrypsy
and lithotrypter. Based on the outcome of the rst
search (as outlined in detail in the next paragraph),
a second search was performed on the key terms
plantar, Achilles, epicondylitis, subacromial, non-
calcic and calcifying.
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Data extraction
The outcome of the rst search is shown in Figure 3.
We identied 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).
1315
Furthermore, all ESWT
studies on wound healing and chronic decubitus
were excluded (n=5).
1620
The remaining records
(n=106) were divided into studies on (i) radial
ESWT with positive outcome (i.e. radial ESWT sig-
nicantly better statistically than either placebo or
alternative treatment modalities) (rESWT+; n= 23),
(ii) radial ESWT with negative outcome (i.e. radial
ESWT not signicantly 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 ux
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 KruskalWallis test
(non-parametric analysis of variance) followed
by pairwise comparisons using Dunns multiple
Table 1 Assessment criteria of the PEDro database (modied 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 fullled)
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 specied.
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 inuences 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.
Efcacy 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 signicant.
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-calcic 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-calcic 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
rst 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: 112), 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 signicant (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 reectors 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 red
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, calcications, etc.; grey dots in the
gures) may result in some parts of the acoustic pulse not reaching the target and, thus, weakening the shock wave energy
(i.e. the energy ux 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: 142 days). On average, the longest intervals
between treatment sessions were reported for Group
fESWTand the shortest intervals for Group rESWT
. However, there were no statistically signicant
(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: 2506000). There were no statis-
tically signicant (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: 0.030.78), 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 (AC) 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 rst focal point (1). The heat generated by this process vaporizes the
surrounding water. This generates a gas bubble centered on the rst focal point, with the gas bubble being lled 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 reectors 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 eld 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
eld (not shown) is used to re a projectile (13) within a guiding tube (14) that strikes a metal applicator (15) placed on the
patients skin. The projectile generates stress waves in the applicator that transmit pressure waves into tissue (16).
Efcacy and safety of extracorporeal shock wave therapy for orthopedic conditions, 2015 5
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between these two groups was statistically signicant
(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 ow chart of the rst 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 specied
(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 0.10.16 (EFD
+
)46 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 0.10.16 (EFD
+
) 3 5 2000 + + + −−−+++ +
Lateral epicondylitis Gündüz et al.
33
+ Not specied R 1.4 bar10 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 0.060.14 (EFD
+
) 3 7 2000 + +++−−++
5 Non-specic
shoulder pain
Damian and
Zalpour
36
+ Masterpuls MP 200
(Storz)
R Not specied 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
Efcacy 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 0.060.12 (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 signicantly better statistically than either placebo or alternative treatment modalities; , rESWT not signicantly better statistically than either placebo or
alternative treatment modalities; T, shock wave technology; R, radial; EFD, energy ux density; EFD
+
, positive EFD; EFD
total
, total EFD; (?), not specied whether EFD
+
or EFD
total
;S, number of
treatment sessions; I, interval between treatment sessions (days). The PEDro assessment criteria 211 are outlined in detail in Table 1. Note that the rst PEDro assessment criterion (Eligibility criteria
were specied) 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 0.080.32 (?) 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 0.0680.40
(EFD
+
)
3 7 2000 + + + + ++++ +
Achilles
tendinopathy
Rasmussen et al.
50
+ Piezoson 100 (Wolf) PE 0.120.51 (?) 3 714 2000 + + + + ++++ +
Plantar fasciopathy Buchbinder et al.
51
Epos Ultra (Dornier) EM 0.020.33 (?) 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 0.040.22
(EFD
+
)
3 7 2000 + + +++++ +
Chung and Wiley
61
Sonocur Basic
(Siemens)
EM 0.030.17 (?) 3 7 2000 + + + −−++++ +
Plantar fasciopathy Buch et al.
62
+ Epos Ultra (Dornier) EM 0.030.36 (?) 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 specied 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-calcic
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 specied 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 specied 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 0.260.32 (?) 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 0.040.22
(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 0.030.17 (?) 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 specied 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 specied
(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 specied
(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 signi-
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: 19), with the highest
mean score in Group fESWTand the lowest mean
score in Group fESWT+ (Fig. 4F). The difference in the
meanPEDroscorebetweenthesetwogroupswas
statistically signicant (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-
nicant (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-calcic: 3/8 = 37.5%
RCTS on non-calcic 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 signicantly better statistically than either placebo or alternative treatment modalities; , fESWT not signicantly better statistically than either placebo or
alternative treatment modalities; T, shock wave technology; EH, electrohydraulic; EM, electromagnetic; PE, piezoelectric; EFD, energy ux density; EFD
+
, positive EFD; EFD
total
, total EFD; (?), not
specied whether EFD
+
or EFD
total
;S, number of treatment sessions; I, interval between treatment sessions [days]. The PEDro assessment criteria 211 are outlined in detail in Table 1. Note that the
rst PEDro assessment criterion (Eligibility criteria were specied) 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-calcic 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 dening 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
conrmed independently.
127
Using RCTs derived only
from the PEDro database, we sought to (i) clarify some
common misconceptions regarding ESWT and (ii) for
specic indications, compare ESWT with other forms
of non-operative treatment.
A meta-analysis is often very helpful when the ef-
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 ux density of the impulses (D), total energy ux
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 briey substantiated by sci-
entic 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 efcacy 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 signicantly 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 fullled for the indications
plantar fasciopathy, non-calcic 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-calcic 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-calcic 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 signicance 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 nding contradicts the belief that betterRCTs
(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.*
130132
* 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 insufcient 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 scientic 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 scientic 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 qualityof RCTs on ESWT in PEDro with positive or negative outcome.
5 Application of local anesthesia adversely affects outcome of ESWT.
6 Application of insufcient energy adversely affects outcome of ESWT.
7 There is no scientic evidence in favor of either rESWT or fESWT with respect to treatment outcome.
8 The distinction between radial ESWT as low-energy ESWTand focused ESWT as high-energy ESWTis not correct
and should be abandoned.
9 There is no scientic 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 ux 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 ESWTand focused ESWT
as high-energy ESWTis not correct
and should be abandoned
Rompe et al.
8
arbitrarily dened an EFD of 0.2 mJ/
mm
2
as the margin between low- and high-energy
shock wave treatments. Following this denition,
100% of the RCTs on rESWT, 45% of the fESWT+
RCTs and 77% of the fESWTRCTs in PEDro
were performed with low-energy shock waves (c.f.
Tables 2and 3). However, other denitions 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 scientic 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 signicant (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 reects 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
ndings 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 betterrecommendation.
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
ESWTaccording to different denitions 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
Efcacy and safety of extracorporeal shock wave therapy for orthopedic conditions, 2015 17
by guest on December 10, 2015http://bmb.oxfordjournals.org/Downloaded from
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 rst 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-
calcic 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 identied 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.
Conict of interest statement
N.B.M.C., S.M., M.S., J.-D.R. and J.P.F. declare that
no competing nancial interests exist. C.S. serves
as a paid consultant for and receives benets 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 conicts
of interest relevant to this article were reported.
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... This resulted in the demonstration of the stimulation of fracture healing with ESWs in animal models [7]. Since these beginnings, the application of ESWs has been expanded to a variety of pathologies of the musculoskeletal system, with the treatment of non-unions (reviewed in [8]) and tendinopathies (reviewed in [9][10][11]) being, by far, the largest groups of indications. The treatment of pathologies of the musculoskeletal system with ESWs is commonly referred to as Extracorporeal Shock Wave Therapy (ESWT) and is thus distinguished from ESWL. ...
... The second take-home message of this study is that different tissues respond to the same mechanical stimulus in different ways. Based on many years of clinical experience and numerous clinical studies, various pathologies of the musculoskeletal system are known nowadays that can be successfully treated with ESWT [8][9][10][11]. These indications include mainly degenerations and injuries of muscle, bone and cartilage tissue. ...
... Numerous effects were described for both fESWT and rESWT, however, more effects were described for fESWT (Tables 1-3). This may be due to the fact that fESWT was developed before rESWT [10]. From a physics point of view, these two forms of ESWT appear to differ greatly. ...
Article
Full-text available
Extracorporeal shock wave therapy (ESWT) is a safe and effective treatment option for various pathologies of the musculoskeletal system. Many studies address the molecular and cellular mechanisms of action of ESWT. However, to date, no uniform concept could be established on this matter. In the present study, we perform a systematic review of the effects of exposure of musculoskeletal tissue to extracorporeal shock waves (ESWs) reported in the literature. The key results are as follows: (i) compared to the effects of many other forms of therapy, the clinical benefit of ESWT does not appear to be based on a single mechanism; (ii) different tissues respond to the same mechanical stimulus in different ways; (iii) just because a mechanism of action of ESWT is described in a study does not automatically mean that this mechanism is relevant to the observed clinical effect; (iv) focused ESWs and radial ESWs seem to act in a similar way; and (v) even the most sophisticated research into the effects of exposure of musculoskeletal tissue to ESWs cannot substitute clinical research in order to determine the optimum intensity, treatment frequency and localization of ESWT.
... ESWT can be used as a monotherapy [16], but is usually part of a multimodal treatment strategy [11], and is considered to improve long-term outcomes when combined with eccentric exercises [17]. ESWT is reported to be safe [18,19] and (cost) effective for patients with persistent AT who have low responsiveness to standard care [11,19], but the evidence is conflicting [11,12,20,21]. ...
... Caution is warranted when interpreting this pooled estimate, as it is unlikely that ESWT nullifies the effect of a standard care program. Both R-ESWT and F-ESWT have been reported to be safe interventions, with adverse effects such as post-therapy transient skin reddening or discomfort, typically being minor or occurring rarely [18,19,54]. Our negative pooled estimate is most likely the consequence of including the study of Notarnicola et al. [43] in our synthesis, being the only study showing a statistically significant negative effect of ESWT for ins-AT (Fig. 4). ...
Article
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Background Extracorporeal shockwave therapy (ESWT) is used commonly to treat pain and function in Achilles tendinopathy (AT). The aim of this study was to synthesize the evidence from (non-) randomized controlled trials, to determine the clinical effectiveness of ESWT for mid-portion Achilles tendinopathy (mid-AT) and insertional Achilles tendinopathy (ins-AT) separately. Methods We searched PubMed/Medline, Embase (Ovid), and Cochrane Central, up to January 2021. Unpublished studies and gray literature were searched in trial registers (ACTRN, ChiCTR, ChiCtr, CTRI, DRKS, EUCTR, IRCT, ISRCTN, JPRN UMIN, ClinicalTrials.gov, NTR, TCTR) and databases (OpenGrey.eu, NARCIS.nl, DART-Europe.org, OATD.org). Randomized controlled trials (RCTs) and non-randomized controlled clinical trials (CCTs) were eligible when investigating the clinical effectiveness of ESWT for chronic mid-AT or chronic ins-AT. We excluded studies that focused on treating individuals with systemic conditions, and studies investigating mixed cohorts of mid-AT and ins-AT, when it was not possible to perform a subgroup analysis for both clinical entities separately. Two reviewers independently performed the study selection, quality assessment, data extraction, and grading of the evidence levels. Discrepancies were resolved through discussion or by consulting a third reviewer when necessary. Results We included three RCTs on mid-AT and four RCTs on ins-AT. For mid-AT, moderate quality of evidence was found for the overall effectiveness of ESWT compared to standard care, with a pooled mean difference (MD) on the VISA-A of 9.08 points (95% CI 6.35–11.81). Subgroup analysis on the effects of ESWT additional to standard care for mid-AT resulted in a pooled MD on the VISA-A of 10.28 points (95% CI 7.43–13.12). For ins-AT, we found very low quality of evidence, indicating that, overall, ESWT has no additional value over standard care, with a standardized mean difference (SMD) of − 0.02 (95% CI − 0.27 to 0.23). Subgroup analysis to determine the effect of ESWT additional to standard care for ins-AT showed a negative effect (SMD − 0.29; 95% CI − 0.56 to − 0.01) compared to standard care alone. Conclusions There is moderate evidence supporting the effectiveness of ESWT additional to a tendon loading program in mid-AT. Evidence supporting the effectiveness of ESWT for ins-AT is lacking. Trial Registration : PROSPERO Database; No. CRD42021236107.
... Early intervention in the precollapse stage of the femoral head is still critical for a successful outcome [3][4][5]. High-energy extracorporeal shock wave therapy (ESWT) is a noninvasive technology that has been successfully used in various musculoskeletal conditions, such as tennis elbow, plantar fasciitis, fracture nonunions, and lateral epicondylitis [6][7][8]. e extracorporeal shock wave is a kind of mechanical wave with high pressure and energy that forms reflection and precipitation on the interface between soft tissue and bone [9][10][11]. Multiple clinical studies have demonstrated the therapeutic potential of ESWT in the early stage of ONFH with improved clinical prognosis and a decrease in osteonecrosis [12,13]. ...
Article
Full-text available
Background. Multiple reports have demonstrated the therapeutic potential of extracorporeal shock wave (ESWT) in osteonecrosis of the femoral head (ONFH). However, few studies reported the changes in hip articular cartilage after the intervention. This study aimed to investigate the effect of ESWT on femoral head cartilage using a novel technique, quantitative T2-mapping magnetic resonance imaging. Methods. A total of 143 eligible patients with unilateral early-stage ONFH were randomized into the ESWT group and control group. Seventy-three patients in the ESWT group received two sessions of ESWT with oral drug treatment, while seventy patients in the control group received oral drug treatment only. The visual analog pain scale (VAS) and Harris hip score (HHS) at 3-month, 6-month, and 12-month follow-up were used as the clinical evaluation index. The radiological evaluation index used the T2 mapping values, necrotic size, and China-Japan Friendship Hospital (CJFH) classification. Results. A total of 143 patients (62 females and 81 males) were finally included, and the characteristics before treatment were comparable between the two groups. At the last follow-up (12 months), the T2 values and ΔT2 changes in the ESWT group were all smaller than those in the control group ( p = 0.042 ; p = 0.039 ), while the CJFH classification of ONFH and necrotic lesion size were not statistically significant. At 3 months and 6 months, the VAS in the ESWT group was lower than that in the control group ( p = 0.021 ; p = 0.046 ) and the HHS in the ESWT group was higher ( p = 0.028 ; p = 0.039 ). However, there were no significant differences in the VAS and HHS at 12 months between the ESWT and control groups. Conclusions. The results of the current study indicated that, based on drug treatment, ESWT is an effective treatment method for nontraumatic ONFH, which could result in significant pain relief and function restoration. Furthermore, it could delay the injury of femoral head cartilage during the progression of ONFH.
... ESWT might represent a valuable therapeutic tool for enhancing tissue regeneration in various musculoskeletal diseases [27][28][29] . SW are acoustic waves that when applied to living tissue induce a cascade of biological cellular reactions based on the activation of interconnected biomechanical pathways that ultimately stimulate local tissue regeneration through the secretion of various growth factors 2,30-34 . ...
Article
Full-text available
Objective: The aim of the study is to review the available literature on the use of Extracorporeal Shock Wave Therapy (ESWT) for the treatment of osteonecrosis (ON) and bone vascular disease (BVD), to understand its therapeutic potential and compare it with other therapies. Materials and methods: A systematic review was performed on the PubMed, Scopus, Science Direct, and Research Gate databases with the following inclusion criteria: 1) randomized controlled trials (RCTs); 2) written in English; 3) published in indexed journals within the last 25 years (1995-2020); and 4) dealing with the use of ESWT for the treatment of BVD or ON. The risk of bias was assessed by the Cochrane Risk of Bias tool for RCTs. Results: Five studies involving 199 patients in total (68 female and 131 male) were included. Patients in the control groups received different treatments, like surgery, bisphosphonates in combination with prostacyclin or ESWT, and hyperbaric oxygen therapy. Looking at the quality of the available literature, none of the studies included could be considered a "good quality" study; only one was ranked as "fair" and the remaining were marked "poor" quality studies. No major complications or serious adverse events were reported in any of the included studies. Based on the available data, ESWT can produce rapid pain relief and functional improvement. Conclusions: Overall, a substandard quality of method emerged from the analysis of the literature, with most studies flawed by relevant bias. Ultimately, ESWT has the potential to be a useful conservative treatment in bone degeneration due to vascular and tissue turnover impairment.
... Collectively, the studies on ESWT for MTrPs of the UTM published so far [20][21][22][23][24][25][26][27][28][29][30][31][32][33][34][35][36][37] did not show any advantage of focused ESWT (fESWT) over rESWT or vice versa (a detailed discussion of differences between and similarities of fESWT and rESWT is provided in [56]). This is important because the use of fESWT is restricted to physicians in many countries (as is the case in Germany where chiropractors and physiotherapists who have been trained in Germany are not legally entitled to use fESWT). ...
Article
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Background and Objectives: This study tested the hypothesis that treatment of myofascial trigger points (MTrPs) in the upper trapezius muscle (UTM) with repeated injection of 1% lidocaine results in better alleviation of muscular stiffness and soreness as well as improved metabolism in the hypercontracted MTrP area than treatment with radial extracorporeal shock wave therapy (rESWT). Materials and Methods: A single-blinded, prospective, randomized controlled trial was conducted on patients suffering from MTrPs in the UTM. Thirty patients were treated with repeated injection of 2 mL of 1% lidocaine (three injections; one injection per week). Another 30 patients were treated with rESWT (three treatment sessions; one treatment session per week; 2000 radial extracorporeal shock waves per treatment session; positive energy flux density = 0.10 mJ/mm2). The primary outcome measure was pain severity using the VAS score. The secondary outcome measures included muscle elasticity index, pressure pain threshold and neck disability index. Evaluation was performed at baseline (T1), 15–30 min after the first treatment in order to register immediate treatment effects (T2), before the second treatment (i.e., one week after baseline) (T3) and one week after the third treatment (i.e., four weeks after baseline) (T4). Results: There were no statistically significant differences in the primary and secondary outcome measures between the patients in the lidocaine arm and the patients in the rESWT arm at T1 and T4. Within the arms, the mean differences of all outcomes were statistically significant (p < 0.001) when comparing the data obtained at T1 with the data obtained at T3 and the data obtained at T4. Conclusions: The results of this pilot study suggest that the use of rESWT in patients with MTrPs in the UTM is safe and leads to reduced pain and improved muscle elasticity, pressure pain threshold and neck disability index, without adverse effects. Larger trials are necessary to verify this. Clinicians should consider rESWT instead of injections of lidocaine in the treatment of MTrPs in the UTM.
... ESWT has been extensively used for the management of MSK disorders like unhealed fractures, plantar fasciitis, lateral epicondylitis, calcific RC tendinopathies, and heel pain [20]. These multiple mechanisms are involved in the therapeutic effects of ESWT; mechanical stimulation increased regional blood flow and enhanced expression of growth factors [21]. ...
Article
Full-text available
Objective: The current trial was designed to evaluate the effects of high-energy shockwave therapy on objective and subjective outcomes among participants with calcified rotator cuff tendinopathy. Methods: This parallel-group, randomized trial consists of 42 patients affected by calcific tendinopathies divided into two groups of 21 participants. Patients having calcified tendinopathy aged between 30 and 65 years with type A or B calcification were selected in the trial after signing the written consent form. Participants in the ESWT+RPT group received eight sessions of shockwaves, while the RPT group was treated by routine physical therapy. About 2000 shockwaves of 0.32 mJ/mm2, 120 Hz per treatment, were given as 12 sessions for the first six weeks (2 sessions/week). Pain intensity and shoulder functional ability, ultrasonographic changes, and quality of life were assessed with the numeric pain rating scale (NPRS), Constant-Murley score (CMS), ultrasonography, and Western Ontario rotator cuff index (WORC). Results: There were significant differences regarding NPRS and CMS between the two groups, at baseline and 6th and 12th weeks after intervention (p < 0.05). Within-group differences also showed statistically significant results after treatment (all p < 0.05). Significant results were seen in the WORC and ultrasonographic results pre- and posttreatment; more significant findings were found in the experimental group as compared to others. Conclusion: High-energy shockwave therapy has been proved to be effective and thus strongly recommended for the management of calcified rotator cuff tendinopathy, improving the pain, functionality, and quality of life of these participants and decreasing the size of calcified deposits. Shockwave therapy is proved to be superior to routine physiotherapy.
Article
This systematic review evaluates the available evidence for extracorporeal shockwave therapy (ESWT) use in the treatment of medial tibial stress syndrome (MTSS). PubMed, EMBASE, Scopus, ISI Web of Science, and Cochrane Central Register of Controlled Trials (Cochrane CENTRAL) database searches were performed without a time limit in August 2021. Two independent researchers performed the search, screening, and final eligibility of the articles. Data were extracted using a customized spreadsheet, which included detailed information on patient characteristics, interventions, and outcomes. The methodological quality of the included studies was independently assessed by two reviewers using the Physiotherapy Evidence Database scale (PEDro). Three studies were identified that compared 23, 12, and 22 participants in the intervention group with 19, 12, and 20 participants in the control group, respectively. The mean age of participants in these studies was 26.51 yr, and the mean duration of symptoms in the two studies that reported this was 16.36 mo. All studies used focus shockwave therapy. Extracorporeal shockwaves reduced pain and time to recovery and increased patient satisfaction. No study reported adverse effects. Based on the limited studies, ESWT may reduce pain and shorten recovery duration in MTSS. Further randomized clinical trials with sham control may substantiate these findings in other patient populations. Level II.
Chapter
Ultraschall ist eine Anwendung, bei der mechanische Energie umgesetzt wird in Wärme. Die mechanische Einwirkung hat außerdem wahrscheinlich eine spezifische eigene Wirkung. Die Erwärmung findet vor allem statt in Gewebe mit einer hohen Dichte, wie Bändern, Gelenkkapseln und Narbengewebe, auf einer Tiefe von maximal 5 cm. Die Schallenergie wird auch benutzt, um Medikamente einzuschleusen, wobei die Sonophorese dazu besser geeignet scheint als die Iontophorese.
Article
Full-text available
This randomised controlled trial was designed to evaluate the efficacy of low-energy extracorporeal shockwave therapy with a supervised exercise protocol for the treatment of chronic lateral epicondylitis. Thirty patients of lateral epicondylitis were randomly placed into two groups: an experimental group (n = 15) and a control group (n = 15). The experimental group received low-energy extracorporeal shockwave therapy and supervised exercise once a week for 3 weeks, whereas the control group received a supervised exercise protocol three times a week. Both the groups were instructed to carry out a home exercise programme twice daily for 4 weeks.Outcome parameters included in this study were pain intensity, pain-free grip strength, and the Disability of Arm, Shoulder, and Hand questionnaire. Data were collected at baseline and after the end of treatment (at 4th week). There was a decline in pain, and improvements in pain-free grip strength and limb function in both groups compared with the baseline values. At the end of the treatment period, the experimental group had greater reduction in pain intensity and better improvement in limb function (p < 0.01). It can be concluded that low-energy extracorporeal shockwave therapy, when combined with regular exercise, is an effective method for reducing pain and improving upper limb function in patients with chronic lateral epicondylitis.
Article
We have performed a double-blind placebo-controlled trial of moderate doses of extracorporeal shock-wave therapy (ESWT) for non-calcific tendonitis of the rotator cuff. Adults (74) with chronic tendonitis of the rotator cuff were randomised to receive either active (1500 pulses ESWT at 0.12 mJ/mm ² ) or sham treatment, monthly for three months. All were assessed before each treatment, and at one and three months after the completion of treatment. The outcome was measured with regard to pain in the shoulder, including a visual analogue score for night pain, and a disability index. There were no significant differences between the two groups before treatment. The mean duration of symptoms in both groups was 23.3 months. Both showed significant and sustained improvements from two months onwards. There was no significant difference between them with respect to change in the Shoulder Pain and Disability Index (SPADI) scores or night pain over the six-month period. A mean (±sd; range) change in SPADI of 16.1 ± 27.2 (0 to 82) in the treatment group and 24.3 ± 24.8 (−11 to 83) in the sham group was noted at three months. At six months the mean changes were 28.4 ± 25.9 (−24 to 69) and 30.4 ± 31.2 (−12 to 88), respectively. Similar results were noted for night pain. We conclude that there is a significant and sustained placebo effect after moderate doses of ESWT in patients with non-calcific tendonitis of the rotator cuff, but there is no evidence of added benefit when compared with sham treatment.
Article
We have performed a controlled, randomised study to analyse the effects of low-energy shock-wave therapy (ESWT) on function and pain in tendinitis of the supraspinatus without calcification. There were 20 patients in the treatment group and 20 in the control group. The former group received 6000 impulses (energy flux density, 0.11 mJ/mm ² ) in three sessions after local anaesthesia. The control group had 6000 impulses of sham ESWT after local anaesthesia. The patients were examined at six and 12 weeks after treatment by an independent observer who evaluated the Constant score and level of pain. We found an increase in function and a reduction of pain in both groups (p ≤ 0.001). Statistical analysis showed no difference between the groups for the Constant score and for pain. We therefore do not recommend ESWT for the treatment of tendinitis of supraspinatus.
Article
We report a prospective study of the effects of extracorporeal shock-wave therapy in 195 patients with chronic calcifying tendinitis. In part A 80 patients with chronic symptoms were randomly assigned to a control and three subgroups which had different treatment by low-energy and high-energy shock waves. In part B 115 patients had either one or two high-energy sessions. We recorded subjective, functional and radiological findings at six months after treatment. The results showed energy-dependent success, with relief of pain ranging from 5% in our control group up to 58% after two high-energy sessions. The Constant scores and the radiological disintegration of calcification were also dose-dependent. Shockwave therapy should be considered for chronic pain due to calcific tendinitis which is resistant to conservative treatment.
Article
Background and Purpose. Assessment of the quality of randomized controlled trials (RCTs) is common practice in systematic reviews. However, the reliability of data obtained with most quality assessment scales has not been established. This report describes 2 studies designed to investigate the reliability of data obtained with the Physiotherapy Evidence Database (PEDro) scale developed to rate the quality of RCTs evaluating physical therapist interventions. Method. In the first study, 11 raters independently rated 25 RCTs randomly selected from the PEDro database. In the second study, 2 raters rated 120 RCTs randomly selected from the PEDro database, and disagreements were resolved by a third rater; this generated a set of individual rater and consensus ratings. The process was repeated by independent raters to create a second set of individual and consensus ratings. Reliability of ratings of PEDro scale items was calculated using multirater kappas, and reliability of the total (summed) score was calculated using intraclass correlation coefficients (ICC [1,1]). Results. The kappa value for each of the 11 items ranged from .36 to .80 for individual assessors and from .50 to .79 for consensus ratings generated by groups of 2 or 3 raters. The ICC for the total score was .56 (95% confidence interval=.47–.65) for ratings by individuals, and the ICC for consensus ratings was .68 (95% confidence interval=.57–.76). Discussion and Conclusion. The reliability of ratings of PEDro scale items varied from “fair” to “substantial,” and the reliability of the total PEDro score was “fair” to “good.”
Article
[Purpose] In order to develop a more effective treatment method for pain and function in myofascial pain syndrome, we examined the effects of ESWT, stability exercises, and combined treatment. [Subjects] The subjects were randomly divided into a stabilization exercise group (n=12), an ESWT (Extracorporeal Shock Wave Therapy) group (n=12), and a combined treatment group (n=12). [Methods] The stabilization exercise group performed shoulder joint stabilization exercises. The ESWT group received ESWT for the upper trapezius. The combined treatment group received a combined treatment of shoulder joint stabilization exercises and ESWT. Pain and function were measured using the visual analog scale (VAS), pressure pain threshold (PPT), neck disability index (NDI), and the Constant Murley Scale (CMS). [Results] The VAS Score showed statistically significant improvements in all of the groups. All of the CMS evaluation items except muscle strength in the stabilization exercise group, and all of the CMS items in the ESWT group and the combined treatment group, exhibited statistically significant improvements. The combined treatment group of ESWT and stabilization exercises showed statistically significant improvements in all VAS of CMS evaluation items, and the NDI test after the four-week intervention. [Conclusion] The combined treatment was more effective at reducing pain than ESWT, and stabilization exercise would be useful for physical therapists treating myofascial pain syndrome in a clinical setting.
Article
Extracorporeal shock wave therapy (ESWT) is seen as a therapeutic option in the treatment of chronic supraspinatus tendinitis by some authors. To test whether ESWT comprising 3×2000 pulses with the positive energy flux density ED+ of 0.33 mJ/mm2 is clinically superior to a sham ESWT treatment, a prospective, randomized, single-blinded, placebo-controlled study with an independent observer was performed. Forty patients were treated either by verum ESWT or sham ESWT under local anesthesia. Target criteria were the age-corrected Constant score, pain at rest and during activity on a visual analogue scale, and subjective improvement. Patients who reported no subjective improvement after 12 weeks were deblinded and received verum ESWT if they had belonged to the placebo group (partial crossover). The results of the verum group lie within the range of results for ESWT published by other authors. Patients in the placebo group with local anesthetic showed equally good results. At 12 weeks, and 1 year after intervention, no difference could be found between the verum and placebo groups regarding Constant score, pain, shoulder function, or subjective improvement. The nonresponders to the placebo ESWT continued to show no improvement after receiving verum ESWT. This contradicts a specific ESWT effect. Based on the results of this placebo-controlled study, ESWT appears to have no clinically relevant effect on supraspinatus tendinitis. The study underlines the importance of a control group in evaluating new treatment methods for diseases with unknown natural history.
Article
Objective: The aim of this study was to investigate the effects of shock wave therapy on gait pattern in children with hemiplegic cerebral palsy. Design: Fifteen children were assigned to the study group, whose members received shock wave therapy (1500 shots/muscle, frequency of 5Hz, energy of 0.030 mJ/mm, one session/wk). Another 15 were assigned to the control group, whose members participated in a conventional physical therapy exercise program for 3 successive months. Baseline and posttreatment assessments were performed using the Modified Ashworth Scale to evaluate spasticity degrees and using a three-dimensional gait analysis to evaluate gait parameters. Results: Children in the study group showed a significant improvement when compared with those in the control group (P < 0.005). The Modified Ashworth scores after treatment were 1.86 (0.22) and 1.63 (0.23) for the control and study groups, respectively. The gait parameters (stride length, cadence, speed, cycle time, and stance phase percentage) after treatment were 0.5 m, 125 steps/min, 0.6 m/sec, 0.48 sec, and 50.4% and 0.74 m, 119 steps/min, 0.75 m/sec, 0.65 sec, and 55.9% for the control group and the study group, respectively. Conclusions: Shock wave therapy may be a useful tool for improving spasticity and gait pattern in children with hemiplegic cerebral palsy.