Mastersthesis Ægir Óli Hreint Skjal
Mastersthesis Ægir Óli Hreint Skjal
Mastersthesis Ægir Óli Hreint Skjal
Fjöldi eininga: 30
Námsbraut í sjúkraþjálfun
Læknadeild
Maí 2021
Extracorporeal Shockwave Therapy
Does a systematic review of the literature (2017-2020) justify It being taught to
physical therapy students?
Number of credits: 30
Faculty of Medicine
May 2021
Thesis for Master degree in Physiotherapy at the University of Iceland. No part of this
publication may be reproduced in any form without the prior permission of the copyright
holder.
© Ægir Óli Kristjánsson 2021
Niðurstöður: Tuttugu rannsóknir voru valdar til skoðunar. Það eru sterkar, rökstuddar sannanir fyrir
notkun ESWT, óháð greiningu. Niðurstöður benda til þess að öll svið orkuþéttni sýni áberandi jákvæðar
niðurstöður. Meðalhætta á hlutdrægni er til staðar í athugunum á rannsóknum.
Mælt með kennslu um rafmagnstæki fyrir alla sjúkraþjálfunarnema þar sem þekking og innsýn er
grunnur fyrir frekari þróun meðferðarúrræða og notkunar í framtíðinni.
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Abstract
Objective: This study aims to evaluate the evidence for the use of extracorporeal shockwave therapy
(ESWT) based on energy flux density range, regardless of diagnosis or tissue type targeted, and to
determine if it is justifiable to teach physical therapy students about the modality.
Methods: A systematic review of randomised controlled trials from 2017 to 2020 following PRISMA
guidelines was conducted on the PubMed, PEDro and Cochrane databases. Inclusion criteria included
reporting on ESWT and a control group and giving detailed treatment parameters such as energy flux
density, frequency, number of shocks per session and length of treatment. Risk of bias assessment and
data synthesis on the articles chosen for review was performed.
Results: Twenty articles were chosen for the review. There was strong, substantiated evidence for
the use of ESWT, regardless of diagnosis. Evidence suggested that all energy flux density ranges show
strong, substantiated evidence but mid-range level showed prominently more positive results. Moderate
level risk of bias was present in the studies reviewed.
Discussion and conclusion: Evidence for the efficacy of ESWT was strong and substantiated within
the recent literature (2017-2020). Older systematic reviews reported conflicting results on some
diagnoses but were consistent with other diagnoses reviewed when compared to the current study.
Future systematic reviews will need to define inclusion and exclusion criteria further using a single
energy level range to establish clear evidence for substantiated recommendation for the optimal use of
the modality in practice. The evidence would suggest that ESWT be taught to physical therapy students
as knowledge and insight are a foundation for further development of treatment opportunities and uses
for modalities.
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Acknowledgements
Thanks to my advisor, Abby Snook, for her seemingly unending patience and helpfulness and
my girlfriend, Saga Hilma, for putting up with me during the process of this project.
No funding to declare.
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Table of Contents
Contents
Ágrip .........................................................................................................................................................1
Abstract.....................................................................................................................................................3
Acknowledgements ..................................................................................................................................5
1 Introduction .....................................................................................................................................11
4 Results ............................................................................................................................................21
5 Discussion ......................................................................................................................................30
6
5.2 Strengths and limitations ....................................................................................................... 32
6 Conclusions ....................................................................................................................................33
References .............................................................................................................................................34
Attachments ............................................................................................................................................38
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List of figures
Figure 1 - Graph of pressure vs. time for radial and focused shockwaves ...................................... 11
8
List of tables
Table 1 - Effects of energy dose on tendon tissue ........................................................................... 14
9
List of abbreviations
ESWT – -extracorporeal shockwave therapy
Hz – Hertz
mm – millimeter
mJ – millijoule
PF – plantar fasciitis
AT – Achilles Tendinopathy
PT – patellar tendinopathy
CC – claudication
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1 Introduction
Extracorporeal shockwave therapy (ESWT) is a more recent modality in physical therapy and has been
used to treat orthopedic conditions over the last two decades (Prentice & Thigpen, 2018). In the
beginning, it was used to treat mostly musculoskeletal conditions by physical therapists and by other
medical professionals (e.g., urologists using shockwaves to treat kidney stones (Thiel et al., 2000)). In
more recent years, it has, however, been tested on other conditions such as spasticity in stroke patients
and erectile dysfunction in men (Fojecki et al., 2017) (Xiang et al., 2018). Despite some evidence for its
effectiveness in treating musculoskeletal conditions, spasticity and erectile dysfunction, there also
appears to be conflicting evidence that does not show the same effect when similar studies are done
(Speed, 2014).
Figure 1 - Graph of pressure vs. time for radial and focused shockwaves, MPa = MegaPascal; ms
= millisecond; µsec = microsecond (attribution) (Venn Healthcare 2020)
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Focused shock wave devices generate energy electromagnetically, electro-pneumatically, or
piezoelectrically which has a small focus area with the maximum energy output targeting up to 12
centimeters subcutaneously (Shrivastava & Kailash, 2005). The energy generated with a fESWT
machine is then delivered to a small point, resulting in more energy in a smaller space. This method has
been used in the treatment of kidney stones for example. When using shockwaves to treat kidney stones
the goal is to get rid of unwanted material without the destruction of the targeted tissue. Each of the
energy generation methods have a different penetration depth and focal volume so, when targeting
different sites or tissues, one method might be better suited than another. Radial shock wave devices,
on the other hand, are most often pneumatically actuated, but can also be electromagnetically
generated, and develop their maximum energy at the skin surface and distribute it radially into the tissue
(Staritz et al., 1989). An advantage of this method over fESWT is that a larger volume of tissue can be
treated and the lower pressure generated has less destructive effect on the tissue targeted (Lohrer et
al., 2010). See Figure 2 for a representation of how the energy is distributed as well as a demonstration
of the difference between rESWT and fESWT as to how the shockwaves spread and how the energy
flux density differs between the modalities (Prentice & Thigpen, 2018). Additional effect of delivering
less pressure over longer time is the reduced chance for patient to require local anesthesia. Local
anesthesia has been shown to reduce the effects of ESWT so reducing the need for anesthesia would
also increase the desirable effects of the treatment (Klonschinski et al., 2011).
Figure 2 - Different wave generation and target of shock waves, (Kiessling, Milz, Frank, Korbel, &
Schmitz, 2015)
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water content of tissues is based on the intracellular matrix and water in the extracellular space. The
more water that is inside and between cells in a tissue, the more flow of nutrients and blood there is
(Prentice & Thigpen, 2018). ESWT has been shown to increase the cell permeability, increase flow of
water in tissues and improve the cellular environment for healing in vivo and in vitro (van der Worp et
al., 2013) (Alderfer et al., 2018). The effects of ESWT on tissues are the reasons different parameters
are used when treating ailments affecting different tissues. (Prentice & Thigpen, 2018).
ESWT is thought to have an effect on the interface between cancellous and cortical bone. It is
thought that the shockwave therapy causes cavitation in the tissue and increases cell permeability
allowing increased vascularity and bony regeneration (Prentice & Thigpen, 2018). Additionally, the local
increase in growth factor, neovascularization, and protein synthesis, in addition to the increase in
osteoprogenitor cells, suggests that shockwave therapy can improve the tissue environment for healing
to occur (Yamaya et al., 2014). There are dangers to using shockwave therapy on bone at higher
intensities, however, as the damage caused in the tissue can be too great and the body is unable to
overcome the damage. This damage can delay the healing and cause mechanical instability (Wang et
al., 2002). The process of tendon healing is thought to be the same as in bone but, instead of primary
healing taking place between cancellous and cortical bone, it is thought to take place between the
tendon and the bone (Wang et al., 2002).
There has been animal research conducted on the use of ESWT to encourage vascular growth by
stimulating vascular endothelial growth factor (VEGF) (Yamaya et al., 2014). The authors of this
experiment concluded that low-energy ESWT significantly increased expressions of VEGF in subjects
without any detrimental effect. ESWT also significantly reduced neuronal loss in damaged neural tissue
and improved locomotor function after spinal cord injury (SCI) (Yamaya et al., 2014). These results are
promising in the treatment of patients with SCI as the treatment is non-invasive and according to this
study, harmless. The parameters used in this research were 0.1 mJ/mm2 (2.5 bar is roughly 0.1 mJ/mm2
), 4 Hz with 200 shots per spot and 2 spots per treatment (Rompe, 2010). This was not a human trial
but performed on rats, but the results are none the less promising.
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delivering enough energy there in a short duration of time. The parameters give us the information on
these factors. The energy flux density (mJ/mm2), number of shocks per session and frequency (hertz)
informs the therapist as to the energy being delivered to the targeted tissue. The targeted tissue however
must be within the focal volume of the shock wave generating device. This focal volume can be
manipulated to make sure the energy is reaching its desired target (Prentice & Thigpen, 2018).
It would be of interest to look at the research published from beginning of 2017 till the end of
2020. The reason for that is that there are several systematic reviews published around 2017 and earlier
that state a need for clearer reporting on treatment protocols, having a better quality of studies to review,
comparison between fESWT and rESWT and having a longer follow-up period (Fojecki et al., 2017;
Huisstede et al., 2018; Korakakis et al., 2018; Mani-Babu et al., 2015; Roerdink et al., 2017; Schmitz et
al., 2015). Mani-Babu et.al. determined ESWT to be an effective intervention for lower limb
tendinopathies, but suggested more robust RCTs with larger sample sizes, control groups, and objective
functional tests are needed to build upon the limited/moderate evidence that is currently available (Mani-
Babu et al., 2015). Studies on the effect of ESWT on spasticity have, likewise, reported positive findings
but also concluded that there was a need for further meta-analysis with well-designed and large-scale
RCTs (Guo et al., 2017). Reviewing RCTs from the years following these publications, it is fair to
assume that reporting on treatment protocols may be more detailed and would allow for synthesis of
these factors that earlier systematic reviews claimed were lacking.
In recent years, the information and knowledge on the best practice and use of ESWT in clinical
settings has improved. Earlier there were still gaps as to what kind of treatment parameters worked best
on different tissues and pathologies. More recent studies have made a conscious effort to research the
effect of parameters to fill this void of knowledge (Liao et al., 2018; Stania et al., 2019; Thiele et al.,
2015).
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2 Aims and objectives
The aim of this systematic review of recent literature is to evaluate the latest evidence from 2017-2020
for the use of ESWT with particular interest in treatment parameters. When reviewing the parameters
used, the reviewer can identify further where the evidence leads with regard to optimal parameters and
treatment protocols. The aim was to examine the effectiveness of ESWT for a variety of pathologies,
comparing the modality with a control group to single out the use of shockwave therapy as the
independent variable.
The clinical usage of this these is to provide current evidence of the optimal use in the treatment of
different pathologies and tissues to both clinicians and teachers. With the assessment of current
evidence for the use of ESWT, teachers are more able to weigh whether a modality should be taught to
students. That leads to the question, should ESWT be taught to students in physical therapy?
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3 Methods and Materials:
A systematic review of recent literature was performed according to the PRISMA (preferred Reporting
Items for Systematic Reviews and Meta-Analyses) guidelines (Page et al., 2021). To achieve a good
overview of the outcomes and statistically significant efficacy of a modality, a systematic review is a
good approach if performed with diligence and good guidelines.
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Articles being searched for were randomized controlled trials and clinical trials of ESWT as a modality
on any pathology, tissue type, or population. Inclusion criteria included that there must be a control
group present. Control groups could receive either placebo, sham-therapy or standard care. Studies
that only compared ESWT to another modality (e.g., ultra-sound) were excluded as, without a control
group, the researchers are unable to make a claim as to whether the condition would have improved
with or without treatment. Furthermore, studies must have presented information on parameters used
for each shock wave treatment, the population, ailments, tissue types targeted, length of treatment,
outcome measures and follow-up duration. Incomplete data on more than one of these excluded a study
from review. Some leeway was given to inclusion of an article if one of the parameters are missing but
others were given, or if one of the two outcome measures were not a part of the study. The studies
selected had a publishing date from the beginning of 2017 to the end of 2020, spanning a 4-year period.
Any studies earlier than that were not included as previous systematic reviews should include any
articles worth reviewing.
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administered (radial or focused). Targeted tissues in the study as well as pathologies were also
recorded. Author name and publication year were also recorded. The outcome measures chosen were
pain (measured with visual analog scale (VAS), numeric rating scale (NRS), Western Ontario and
McMaster Universities osteoarthritis index (WOMAC), pressure pain threshold (PPT), thermometer pain
scale (TPS) and pain-free walking distance (PFWD)) and movement and/or mobility. The latter category
was intentionally broad as no homogeneity was present among articles that study this specific modality.
Some examples of movement and/or mobility measures were the following instruments:
Lequesne
Running distance
proprioception
SF-36 - short-form 36
Six of the seven risk assessment criteria from The Cochrane Collaboration’s Tool for Assessing Risk of
Bias in Randomised Trials were chosen as the reviewer did not feel adequate to judge “other bias”, the
seventh criteria (Higgins, 2011). Risk of bias assessment was performed on six fields of possible bias.
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These fields were random sequence generation, allocation concealment, blinding of participation,
blinding of personnel, blinding of outcome assessment and incomplete outcome data (Higgins, 2011).
These fields were chosen as they were relevant to the bias of the articles, as well as evaluators
confidence in being able to accurately assess these factors.
Points were assigned to each criteria based on the study meeting the standards set in the
Cochrane assessment tool, not meeting the standards, or if it was unclear. Meeting the standard means
a low (+) risk of bias and scores 2 points for said criteria. If it is unclear if the article meets the criteria or
not, it is rated unclear (?) and scores 1 point. If it is clear the article does not meet the criteria it is rated
a high (-) risk of bias and scores 0 points (Higgins, 2011). Given the scoring mentioned and the 6 criteria,
each article could score a maximum of 12 points. Low risk of bias for an article was defined as scoring
10 or more points out of 12 possible points. Medium risk of bias was defined as scoring between 8 to
10 points out of 12 possible. High risk of bias was defined as scoring fewer than 8 points out of the 12
possible total points (Harniman et al., 2004).
A similar standard was used for the overview of all the articles together. Articles with a high risk
of bias overall were scored 0 points, with a medium risk of bias were scored 1 point, and with a low risk
of bias were scored 2 points. For example, if 20 articles were combined, the maximum score would be
40 points. In this case, if the overview score was 32 or more points out of 40 possible, the overall risk of
bias would be considered low. Score of 24 to 31 would result in a medium risk of bias and any fewer
points than 24 would result in a high risk of bias from the selection.
3.6 Synthesis
Data was extracted by the reviewing researcher and put into tables for ease of viewing and interpreting.
The information was presented in separate tables, showing the demographic, the parameters, and the
effect on the outcome. To calculate the effectiveness of the modality over non-use or a control group,
results from each trial were gathered and marked within the table.
A synthesis of the data was performed with respect to the energy flux density levels, separated
into low, medium, and high ranges. Low energy flux density range was defined as <0.08 mJ/mm2,
medium energy flux density range was defined as 0.08 – 0.28 mJ/mm2 and high energy flux density
range was defined as >0.28 mJ/mm2. While there is no standard definition for these ranges, they are
commonly accepted and used frequently in research (Ioppolo et al., 2013; J.-D. et al., 2007;
Mouzopoulos et al., 2007; Rompe et al., 1998). The energy flux density reported in each article was
noted and used to determine what range (low, medium, high) was used. If an article cited energy flux
density that spanned two or more ranges, it was marked into all applicable levels as there was no way
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for an outside reviewer to assess what ranges were effective in treatment. Therefore, the total data
points in the synthesis were expected to exceed the total number of articles applicable for review.
The goal of the synthesis was to be able to provide a statement on where the evidence leads and
how strongly it does so. First of all, research can be classified into 4 classes:
Next, the strength of the evidence was evaluated. The proportion of studies is then used as a basis
for the strength of the evidence:
- Substantiated: when the number of studies reporting improvement is greater or equal to 60%
- Conflicting: when the number of studies reporting improvement is between 40% and 60%
- Unsubstantiated: the number of studies reporting improvement is less than 40%
- Lack of evidence: when there are fewer than five studies of any type.
(Belanger, 2009; Michlovitz & Nolan Jr, 2016)
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4 Results
4.1 Study selection
This systematic review included 20 trials. Flow chart 1 provides the flow diagram of the search and
selection process. All the trials that met the inclusion criteria presented in Table 3 were assessed and
included.
Figure 3 - Flow chart: Exclusion process of choosing papers. ESWT = extracorporeal shockwave
therapy; RCT = randomized controlled trial
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4.2 Quality assessment
The RCTs revealed a mixed risk of bias. Table 3 provides a detailed overview of biases per study.
This was performed in accordance with the Cochrane handbook for systematic reviews of interventions,
version 5.1.0. (Higgins, 2011).
Generally, these studies eliminated risk of bias with regards to random sequence generation,
allocation concealment and incomplete data well but the other areas of risk of bias presented more
mixed results. Blinding of personnel seemed to be the most difficult to eliminate the risk of bias since
the personnel applying the modality is generally aware of their actions but there are precautions that
can be taken and were in a minority of studies.
Half of the studies, or ten, presented with a low risk of bias (earning 2 points each), six studies
presented with a medium risk of bias (earning 1 point each), and 4 presented with a high risk of bias
(earning 0 points). When all the scores were added together (26 points) and were divided by the total
number of points possible (40 points) the overall risk of bias was considered being a medium level of
risk of bias based on the system used. Therefore, some caution should be exercised when assessing
the results.
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Table 3: Risk of bias
generation (selection
(performance bias)
Blinding of outcome
(performance bias)
Random sequence
(attrition bias)
(detection bias)
outcome data
concealment
incomplete
Blinding of
assessment
Allocation
personnel
participant
Blinding of
bias)
(Joo et al., 2020) ? + + - ? +
(Uysal et al., 2020) + + + + ? ?
(Cinar et al., 2020) + + + + ? +
(Ramon et al., 2020) + + + + + +
(Zhong et al., 2019) + + + + + +
(Guo et al., 2019) + + - - + +
(Farhan et al., 2019) + + - - - +
(Takla & Rezk, 2019) + + - + - +
(Aktürk et al., 2018) + + + + ? ?
(Vahdatpour et al., 2018) + + + - + +
(Samhan & Abdelhalim, 2019) + + + - + +
(Kvalvaag et al., 2018) + + + - + +
(Dolibog et al., 2018) + + - - - +
(Harwood et al., 2018) + + + - + +
(Akinoglu et al., 2017) + + - - ? -
(Taheri et al., 2017) + + - - ? +
(Yoon et al., 2017) + + + - - +
(Moon et al., 2017; Thijs et al., 2017) ? + + - + +
(Moon et al., 2017) + + + - + +
(Gomez Garcia et al., 2017) + + - - + +
- signifies high risk of bias, + signifies low risk of bias, ? signifies unclear risk of bias
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4.3 Population characteristics
The total number of articles was 20 with a total of 1161 participants, treating 6 different tissue types and
using both radial and focused shock waves. The order in which the articles are presented in Tables 4-6
is based on the range of energy used to treat going from low to high. Additional information on the
population characteristics of each article can be seen in table 4 below. Muscles and tendons were the
most targeted tissues and spasticity was the most common pathology, followed by plantar fasciitis.
Studies were mostly on adults, aged 30 to 70 and women were better represented in the population.
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4.4 Research parameters
Table 5 provides the treatment parameters for each article. Duration of treatment is the length of the
active treatment protocol and the length of the study refers to the time from the start of treatment until
the final measurements. The frequency range for the selected studies was between 2 and 16 with most
reporting a frequency between 4 and 8 Hz. The energy flux density ranged from .01 mJ/mm 2 to .35
mJ/mm2 with most studies in the low and medium ranges. The most common impulses per session were
2000 impulses per session. Majority of the studies treated once per week for 3 weeks and follow-up
ranged from the duration of the treatment or 3 weeks and 12 months, with most following up the results
for 2-3 months from the beginning of treatment.
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Table 5 Treatment parameters for each article, as well as pathology
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4.5 Outcome measure results
Table 6 provides the outcome measures of each article, as well as energy flux density, the range
assigned to the energy, whether there was a statistically significant improvement (green) or not (red) or
grey if not reported. Measurement tools are also reported with each outcome. Clinically significant
results are marked as a positive and then explained how they are beneficial over the control group and
what measurement tool was used to assess. Results that do not meet the clinically significant values
are marked as negative as the use of the modality in that case is not contributing to the effective
treatment of that patient population.
Of the studies reviewed, 80% of them reported a positive result in either one or both domains
of outcome measures. This was regardless of energy level, tissue targeted or diagnosis. This is
indicative of a wide applicability of the modality in practice.
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Table 6 Results and outcome measures
Research
article Tissue targeted Pathology Energy flux density Range Pain Movement/mobility
(Kvalvaag
et.al. 2018) tendon SPS 0.01-0.35 mJ/mm2 L/M/H NRS SPADI
(Cinar et.al.
2020) fascia PF 0.02 mJ/mm2 L
(Takla et.al.
2019) fascia PF 0.02-0.28 mJ/mm2 L/M/H VAS and PPT FFI - disability subscale
(Farhan
et.al. 2019) muscles SCP 0.03 mJ/mm2 L Not reported MAS and MHC
(Samhan NRS, PPT and physical capabilities
et.al. 2018) skin Burn 0.05-0.20 mJ/mm2 L/M NRS (BSHS-B)
(Joo et.al.
2020) skin Burn 0.05-0.30 mJ/mm2 L/M/H VAS
(Yoon et.al. Less spasticity MAS imp
2017) muscle SPS 0.068-0.093 mJ/mm2 L/M not reported hand function MTS scores
(Aktürk muscles and VAS, PPT and
et.al. 2018) fascia MPS 0.07-0.12 mJ/mm2 L/M TPS imp SF-36 scores
(Uysal et.al.
2020) bone KOA 0.09-0.12 mJ/mm2 M VAS imp. perf and ROM
(Guo et.al.
2019) muscles/tendons SPS 0.09-0.12 mJ/mm2 M MAS MAS and FMA
(Moon et.al.
2017) bone SIJP 0.09-0.25 mJ/mm2 M NRS ODI
(Taheri reduced spasticity (LEFS)
et.al. 2017) muscle SPS 0.1 mJ/mm2 M VAS and increased P-ROM
(Zhong VAS and
et.al. 2019) cartilage/bone KOA 0.105 mJ/mm2 M WOMAC womac and Lequesne
(Harwood max walking distance
et.al. 2017) muscles CC 0.16 mJ/mm2 M PFWD (MWD)
(Dolibog 0.173 mJ/mm2 F
et.al. 2018) skin Ulcers 0.17 mJ/mm2 R M not reported reduced ulceration area
QoL and performance
(Ramon during ADL, (HHS, LEFS,
et.al. 2020) tendon GTPS 0.2 mJ/mm2 M VAS EQ-5D)
(Thijs et.al.
2017) tendon PT 0.2 mJ/mm2 M NRS VISA-P
(Garcia
et.al. 2017) bone, muscle MTSS 0.20 mJ/mm2 M VAS increased running distance
(Vahdatpour 0.25-0.4 mJ/mm2 F
et.al. 2018) tendon AT 1.8-2.6 mJ/mm2 R M/H VAS AOFAS
(Akinoglu increased proprioception
et.al. 2017) fascia PF 0.3 mJ/mm2 H and AOFAS score
SPS – Spasticity post stroke; SCP – Spasticity, cerebral palsy; PT – patellar tendinopathy; AT – Achilles
tendinopathy; PF – plantar fasciitis; MPS – Myofascial pain syndrome; KOA – Knee osteoarthritis;
GTPS – Greater trochanter pain syndrome; MTSS – Medial tibial stress syndrome; SAJP – Sacroiliac
join pain; CC – Claudication; R – Radial; F – Focused; mJ – Millijoule; mm2 – millimeters squared.
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4.6 Data synthesis
Table 7 provides the data synthesis on the energy ranges and provides level of evidence for the use of
the modality. All studies were considered class 1 making the evidence provided strong. Each of the
criteria meets the minimum requirement of five studies to be able to make a claim regarding ESWT’s
therapeutic effectiveness. As over 60% of the studies show improvement in pain and mobility, the overall
evidence is considered substantiated for all energy levels (Belanger, 2009; Michlovitz et al., 2012).
Based on the studies reviewed, published 2017 to 2020, there is strong, substantiated evidence
for the use of ESWT, regardless of tissue targeted or diagnosis, presented with a medium risk of bias
of the studies reviewed.
In addition, the author has made available an online dataset where all the information from Tables 4-6
is combined into one Table. It can be viewed at bit.ly/ESWTsr .
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5 Discussion
5.1 Main discussion
This systematic review contributed to the current knowledge by reviewing the ESWT literature from
2017-2020. The goal was to create evidence-based information for clinicians and teachers about the
effectiveness of ESWT with various energy flux density ranges in the treatment of various pathologies.
Eighty percent of the studies reviewed reported positive findings for one or both domains of outcome
measures. This is substantial evidence for the efficacy of the modality. Coupled with the bias
assessment and data synthesis, it can be said that there is strong, substantiated evidence for the use
of ESWT, with an overall medium risk of bias. The bias adds a caveat that cannot be overlooked when
interpretating these results but, nonetheless, the results are positive.
It was encouraging to see that studies appear to have improved at reporting treatment parameters.
Looking at older systematic reviews, it was common to read about a study that reported no treatment
parameters but only outcome measures. This kind of reporting provides very little insight into the efficacy
of the modality as the result is worthless if there is no way to evaluate the treatment parameters (Alves
et al., 2009). Continued efforts should be made to thoroughly report treatment parameters in future
research.
By reviewing the recent literature, there were fields of study that have not been explored before
regarding the use of ESWT. One such that has increased in recent years is the use of ESWT on
spasticity, as there was a stark increase in publications on this subject beginning in 2013. According to
the current study, there continues to be promising evidence for the use of ESWT for patients with
spasticity (see Table 6). This is the sort of unconventional application that may cause a new approach
to a diagnosis or a treatment and requires knowledge and insight into the modality to be possible.
Introducing physical therapists to these mechanics and ideas early in their career can form a foundation
for further research in these areas.
When viewing the results of this review in context with previous studies, there were interesting
findings. With respect to plantar fasciitis and Achilles tendinopathy, this review found very little evidence
for the use of ESWT in the treatment of these conditions. However, Mani-Babu et.al. claimed the
modality to be an effective intervention and stated it should be considered for greater trochanter pain
syndrome, plantar fasciitis and Achilles tendinopathy (Mani-Babu et al., 2015). These contrasting
findings may need to be evaluated further. Although there was some conflict between studies on Achilles
tendinopathy and plantar fasciitis, this review also found good evidence pointing to ESWT’s efficacy
when treating greater trochanter pain syndrome.
Another systematic review on ESWT treatment for lower limb conditions presented contrasting
findings on some pathologies but similar findings on others when compared to the current study.
Korakakis et.al., (2018) presented no evidence for the effectiveness of ESWT on medial tibial stress
syndrome, which is contrary to the findings of this review. They also stated that there was moderate-
level evidence that suggested that ESWT is no better than placebo for patellar tendinopathy, as well as
low-level evidence for the efficacy of ESWT for greater trochanter pain syndrome. Their results agree
with the findings of this review. Finally, regarding their findings of low-level evidence for the effectiveness
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of ESWT on Achilles tendinopathy, this review is in opposition as it did not find the same evidence.
ESWT has also been studied as a modality for treatment of burn patients. Aguilera-Sáez et.al. reported
positive findings, even if the evidence was weak due to scarcity of studies and their low quality (Aguilera-
Sáez et al., 2019). These results agree with the findings from this thesis as a positive effect was found
for the treatment of burn patients with ESWT.
In the data synthesis, the energy flux density level range that displayed the most promising results
were in the mid-range, where the data synthesis showed strong, substantiated evidence for the use of
EWST, which was far more than the other energy flux density ranges studied (see Table 7). Both
outcome domains (pain and mobility) had a higher percentage of studies that showed a statistically
significant improvement in the mid-range, but there were also more studies which lends even more
weight to the evidence. This is an indication for practitioners to aim for that gap of .08 mJ/mm2 to .28
mJ/mm2 when choosing the parameter of energy flux density. One reason could be the intermediate
effect - not using too much energy as to cause unnecessary damage to the tissue but also providing
enough energy as to cause the desired effects at the target site.
Although there is some evidence for treatment within the mid-range, the range of energy flux
densities used in the articles that were part of the current study continues to be too broad. That results
in inability to be able to confidently say which range is the most effective, what range is the least effective
and what range is destructive. When the energy flux density ranges from .01 to .35 mJ/mm 2 it is very
difficult to determine at what stage the desired effect is being caused. Doing a systematic review of
ESWT in the future where the inclusion criteria require that the energy flux density fall completely within
one of the level ranges and targeting a single tissue type or a single diagnosis could lead to a more
robust result. This could result in clinical guidelines for that specific treatment or determining it to be
sub-optimal when compared with other energy flux density ranges. There is still need for more research,
or at least further reviewing of the research being done. Future research should be more selective and
precise with inclusion/exclusion criteria to work towards the statements of optimal parameters of use.
This would provide reviewers with a more substantial and significant evidence that would allow them to
make optimal recommendations for best practice in a clinical setting. To further progress the knowledge
and field of applications, a more stringent treatment protocol for a research could be beneficial as to
determine the precise effects of a specific protocol on a pathology.
31
5.2 Strengths and limitations
The quality of the studies selected as RCTs (class 1) is a strength of this review. The RCTs presented
a medium risk of bias, which while not optimal is still a satisfactory result. The studies provided a good
insight into the treatment protocols so inquiring further into a single study is bound to bear fruit if those
specific criteria are similar between the study and practice. The studies are also recent so previous
reviews and studies were available for them to build upon and avoid pitfalls which may have been more
common earlier in the study of ESWT. ESWT is being used in more fields now than before so having
RCTs studying newer uses, such as spasticity post stroke or caused by cerebral palsy, sheds a new
light on the versatility of the modality and further possibilities for treatment. It should be noted that only
RCTs were considered for this review so there must be some speculation as to the strength of the review
regarding the substantiation of the evidence since non-RCTs were excluded from the analysis.
There were some limitations to the study. The evidence presented is on a wide variety on
parameters, pathologies, and populations over a brief period (2017-2020). This results in a very broad
take on the use of the modality across many pathologies, but limits coming to clear and precise
recommendations regarding best use for a particular pathology in a clinical setting. In addition, the
review was performed by a single, inexperienced reviewer, which may have led to an unknown personal
bias. Having another reviewer would have added a different view and made it possible to challenge one
another in the article screening, establishing criteria and other facets of the review process. Having
reviewers that possessed greater experience in the field of conducting reviews would avoid this limitation
as well but would lead to fewer reviewers over time as learning through actions is required to learn and
gain the experience.
The outcome measures used to assess the effectiveness of the modality were broad. This
broadness allowed for a wider comparison but also limited the certainty with which the evidence can be
claimed to be effective. Circumventing this limitation in the future could be to define specific outcome
measures to be in the inclusion criteria and excluding others. This would provide reviewers with the
ability to make claims on the effectiveness or a lack of on those specific outcome measures.
32
6 Conclusions
The author of this thesis draws the conclusion, based on data synthesis and the articles reviewed, that
there is strong, substantiated evidence for the use of ESWT. When care and effort is put into the
treatment with the modality, it shows statistically relevant improvements over sham therapies or control
groups. The evidence shows that there is good reason to use all energy ranges but showing a slight
preference for the mid-range. Using each energy range for their optimal situation yields better results
instead of using a modality with only one set of parameters for all pathologies.
The evidence presented presents a solid case for the teaching of ESWT to physical therapy students.
Not only is ESWT providing statistically better results in practice today but teaching future physical
therapists the mechanics and optimal use is a good foundation to build best practices on. Having
informed physical therapists that are knowledgeable about a subject will provide the users of healthcare
with a better service. Having the insight into the modality also opens the doors for a different view on
possible uses, spawning new uses for a modality that may or may not be useful but has not been
explored yet. Knowledge, insight and understanding are a solid foundation to build upon and serves as
fuel for the innovation and experimentation for future practitioners.
33
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Attachments
Web address for online document with information from this systematic review, accessible for viewing
by practitioners or the curious: bit.ly/ESWTsr
- Note that the web address is case-sensitive and should be written exactly as displayed above.
38