Original Research

Three Sessions of Radial Extracorporeal

Shockwave Therapy Gives No Additional Benefit
Over “Minimal-Dose” Radial Extracorporeal
Shockwave Therapy for Patients With Chronic
Greater Trochanteric Pain Syndrome: A Double-
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Blinded, Randomized, Controlled Trial

Patrick C. Wheeler, MBChB, PhD, FFSEM (UK),*†‡ Chloe Dudson, RN,* Rachel Calver, BSc, MCSP, SRP,*
Duncan Goodall, MBChB, FFSEM (UK),*§ Kim M. Gregory, MBChB, FFSEM (UK),*‡ Harjinder Singh, BMBS, FFSEM
(UK),*‡ and Kevin T. Boyd, MBBS, FRCS (Tr&Ortho)*

Abstract
Objective: To investigate the outcomes following 3 weekly sessions of radial extracorporeal shockwave therapy (rESWT) in
patients with chronic greater trochanteric pain syndrome (GTPS) presenting to an NHS Sports Medicine Clinic in the United
Kingdom. Design: Double-blinded randomized controlled trial. Setting: A single NHS Sports Medicine Clinic, in the United
Kingdom. Patients: One hundred twenty patients in an NHS Sports Medicine clinic presenting with symptoms of GTPS who had
failed to improve with a minimum of 3 months of rehabilitation were enrolled in the study and randomized equally to the intervention
and treatment groups. Mean age was 60.6 6 11.5 years; 82% were female, and the mean duration of symptoms was 45.4 6 33.4
months (range, 6 months to 30 years). Interventions: Participants were randomized to receive either 3 sessions of ESWT at either
the “recommended”/“maximally comfortably tolerated” dose or at “minimal dose.” All patients received a structured home exercise
program involving flexibility, strength, and balance exercises. Main Outcome Measures: Follow-up was at 6 weeks, 3 months,
and 6 months. Outcome measures included local hip pain, validated hip PROMs (Oxford hip score, non-arthritic hip score, Victorian
Institute of Sport assessment questionnaire), and wider measures of function including sleep (Pittsburgh sleep quality index) and
mood (hospital anxiety and depression scale). Results: Results were available for 98% of patients at the 6-month period. There
were statistically significant within-group improvements in pain, local function, and sleep seen in both groups. However, fewer
benefits were seen in other outcome measures, including activity or mood. Conclusion: There were no time 3 group interaction
effects seen between the groups at any time point, indicating that in the 3 sessions, the “recommended-dose” rESWT had no
measurable benefit compared with “minimal dose” rESWT in this group of patients with GTPS. The underlying reason remains
unclear; it may be that rESWT is ineffective in the treatment of patients with chronic GTPS, that “minimal dose” rESWT is sufficient for
a therapeutic effect, or that a greater number of treatment sessions are required for maximal benefit. These issues need to be
considered in further research.
Key Words: extracorporeal shockwave therapy, tendons, outcome assessment, greater trochanteric pain syndrome
(Clin J Sport Med 2021;00:1–12)

INTRODUCTION “greater trochanteric pain syndrome” (abbreviated to “GTPS”)

will be used, although the criticisms and limitations of this
Greater trochanteric pain syndrome is a common cause of lateral
terminology are accepted.4,7,8
hip pain, with an incidence of 1.8/1000 patients per year in
Greater trochanteric pain syndrome describes an area of
primary care 1 and accounts for 20% of referrals to some reproducible lateral hip pain over the area of the greater
orthopedic spinal centers.2 Greater trochanteric pain syndrome is trochanter, typically spreading to the buttock, or upper lateral
more common in women than in men, and most typically affects thigh and occasionally further, which can sometimes mimic other
people in their 50s and 60s.3–5 It is more common in patients conditions, including nerve root impingement, spinal problem,s
with preexisting low back pain, osteoarthritis of the knee (of or hip joint pathologies.2,4 Examination typically reveals maximal
either leg), and iliotibial band (ITB) pain, although conflicting tenderness in the posterolateral area of the greater trochanter;
evidence exists as to whether it is more common in overweight or however, the majority of clinical tests have been found to have
obese patients.4,6 limited sensitivity for greater trochanteric pain and are poorly able
Greater trochanteric pain syndrome has held a range of to differentiate this from other causes of lateral hip pain.9,10
alternative names over the past few decades, indicating the Identifying those patients with lateral hip pain who do not have
ongoing confusion as to the pathological processes involved. particular problems putting on shoes and socks (differentiating
This varied nomenclature can cause confusion to patients and between GTPS and osteoarthritis of the hip) and those with lateral
clinicians alike, and for the purposes of this article, the phrase hip pain reproduced by the Flexion-Abduction-External Rotation

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P.C. Wheeler et al. (2021) Clin J Sport Med

benefitting at 3 months.15 However, 1 RCT found a

WHAT IS THE CLINICAL RELEVANCE OF significant improvement favoring injections over “usual care”
THIS RESEARCH? at 3 months, but by 12 months, there was no additional benefit
from the injection.16
Many patients with chronic greater trochanteric pain Other conservative treatment options that have been shown
syndrome (GTPS) will improve in measures of local hip to be effective include nonsteroidal anti-inflammatory drugs
function with a graded home exercise program (HEP) and weight loss.4 Surgery has been undertaken in recalcitrant
(flexibility, strength, balance) and 1 of the 2 strengths of cases with mixed results with a wide range of different surgical
radial extracorporeal shockwave therapy (ESWT). techniques reported focusing on the bursa, the tendinopathy,
The benefits seen did not relate to the “dose” of the radial or the ITB components of GTPS, highlighting the uncertainties
ESWT given, with no additional benefits seen in the group as to the underlying pathologies in this condition.17–19
receiving “recommended-dose” versus “minimal dose” Extracorporeal shockwave therapy can also be used to treat
radial ESWT. patients with GTPS. This is the use of high-energy, inaudible,
This study does not support the current practice of the use of sound waves generated externally to the body, which are
3 sessions of radial ESWT performed at the “maximally transmitted through the skin, and are often felt as vibrations.
comfortably tolerated dose” in patients with chronic GTPS. In radial shockwave therapy (rESWT), which is sometimes
called radial pressure-wave (RPW), pressure waves are
typically generated by the means of a pneumatic system with
test, or a positive Trendelenburg test, are considered more reliable compressed air accelerating a projectile to high speed against a
to discriminate GTPS from other hip pain sources.9–11 transmitter head, which is held against the area being treated.
Imaging studies have demonstrated that 88% of patients This kinetic energy is transmitted into the local tissue where it
with trochanteric symptoms having magnetic resonance spreads out into adjacent tissue as a radial wave aspherically,
imaging (MRI) evidence of gluteus tendinopathy compared and although this radial pressure wave loses power the deeper
with 50% of those with hip pain but without specific it passes into tissue, it can potentially cover a broad area
trochanteric symptoms; this difference was found to be through the expansion of the radial wave.20 Extracorporeal
significant.7,12 However, these changes can also occur in a shockwave therapy is most typically performed over 3 sessions
high proportion of patients without GTPS.10,12 Rather than a at weekly intervals to promote a healing response alongside a
diagnostic tool, investigations may be more useful in ruling structured rehabilitation program.21 However, the treatment
out other conditions, such as osteoarthritis of the hip or tears numbers vary between studies with uncertainty as to “optimal
of the gluteal tendons.12 treatment,” 22 with evidence from a case–control study
Many cases of GTPS will settle with simple conservative suggesting benefits of a single treatment session of rESWT in
management options such as time, activity modification, patients with GTPS,23 and another case series that used
physiotherapy, and steroid injections; however, a study based between 1 and 11 sessions (mean, 5.6 sessions) of rESWT.24
in primary care has shown that 1 year after the diagnosis, 36% Currently, there is limited evidence of benefit from the use
of patients with GTPS will still experience pain, and at 5 years, of ESWT in patients with GTPS (Table 1), and the 2011 NICE
this figure is 29%, indicating the often chronic and ongoing guidance (IPG 376) highlighted that the overall evidence was
nature of this condition.1 inconclusive.25 There is case series evidence that suggests
Recent evidence has demonstrated superiority of physio- benefit of rESWT,23,24,26 and 1 RCT has found that rESWT
therapy exercises over steroid injections for patients with was better than physiotherapy or corticosteroid injection at 4
GTPS and supports the use of patient education and exercises months, but at 15 months, there were similar results from
6injection with follow-up periods of up to 1 year.13,14 A study rESWT and physiotherapy and that both were more effective
has demonstrated that patients who received a corticosteroid than corticosteroid injections alone.3 A subsequent systematic
injection had a 2.7-fold chance of recovery compared with review looking at evidence in a range of lower-limb tendon
those who did not.1 Both ultrasound-guided and ultrasound- conditions has suggested that ESWT may be useful in
unguided injections have both been found to be effective in the managing patients with GTPS as an alternative to other
short and medium term, with 41% to 47% patients still conservative treatments, including corticosteroid injection.27

Submitted for publication February 4, 2020; accepted July 3, 2020.

From the *Department of Sport and Exercise Medicine, University Hospitals of Leicester NHS Trust, Leicester, United Kingdom; †School of Sport, Exercise and Health
Sciences, Loughborough University, Loughborough, United Kingdom; ‡National Centre of Sport and Exercise Medicine, Loughborough, United Kingdom; and §DMRC
Stanford Hall, Leicestershire, United Kingdom.
All authors contributed to the writing of the manuscript. P. C. Wheeler is the lead author and principal investigator of the study, performed initial recruitment and final
assessments, and data analysis. C. Dudson performed the rESWT procedures in this study. R. Calver and D. Goodall undertook the interim reviews for many of the
participants. P. C. Wheeler, K. T. Boyd, K. M. Gregory, H. Singh, R. Calver, and D. Goodall undertook active recruitment for the study.
Ethical approval information: This study had all necessary permissions and was registered on a publicly accessible database (ClinicalTrials.Gov identifier NCT02546128.). The
study was given a favorable opinion from an NHS Research Ethics Committee (REC ref 15/EM/0122) and had all required local site approvals. Ongoing reporting to, and
monitoring by, the host Sponsor (UHL NHS Trust) was undertaken (UHL study id 11401/EDGE ref 41336).
As per the submission system, all data are included in this manuscript. Patient involvement, yes or no. No—indirectly only. Although all study participants were asked at
recruitment if they wished to receive a copy of the lay summary of the study results, those who indicated that they did will have a brief lay result of the study posted to their
address.
Corresponding Author: Patrick C. Wheeler, MBChB, PhD, FFSEM (UK), Department of Sport and Exercise Medicine, University Hospitals of Leicester NHS Trust, Leicester
LE1 5WW, United Kingdom (p.wheeler@lboro.ac.uk).
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http://dx.doi.org/10.1097/JSM.0000000000000880

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TABLE 1. Summary of Published Evidence for the Use of ESWT for GTPS
Author ESWT Device/ Participant Age Participant Symptom Duration Conclusion/
(Year) Type Study Notes Number (in yr) Gender in mo F/U Outcome Ref
Seo Case series Radial 18 pts Mean, 59.0 (range, 56% female Mean, 31.8 6 44.5 Mean Effective—but effect (24)
(2018) ESWT—Evotron (from 38 31-78) (range, 6-180 mo) 27 mo possibly decreases
(SwiTech, identified) over time
Kreuzlingen, Significant
Switzerland) multiple improvement in pain
sessions of rESWT at immediate and
until Roles–Maudsley longer-term outcome
score improved “Success” was
(mean, 5.6 sessions; 83.3% (immediate)
range, 1-11 rESWT vs 55.6% (longer
sessions) term)
Korakakis Systematic 1 RCT,25 1 295 pts Mean 46-51 . .12 Effective (54)
(2018) review case–control study23 total mo
were included ESWT
. physio at 3 and 12
mo
Wheeler Case series Radial 45 pts Mean, 60.0 6 15.4 80% female Mean, 43.2 6 29.8 6 mo Effective (26)
(2016) ESWT—“Intelect” (range, 6-120) Significant
RPW ESWT machine improvements in
(DJO global pain, sleep quality,
Chattanooga) 3 local hip function,
weekly sessions of and depressive
rESWT symptoms but no
change in activity
levels and global
health markers
following rESWT
Mani- Systematic 2 studies included in Probably effective (27)
Babu review review—1 RCT,25 1
(2014) case–control study23
NICE Review Inconclusive (25)
(2011)
Rompe Unblinded Radial shock wave 229 pts Mean 47.7 72% female Mean, 13.4 (range, 15 mo Effective (3)
(2009) RCT device—Swiss 8-40) At 1 mo: CS . ESWT
DolorClast, (Electro At 4 mo: ESWT .
medical systems, HEP/CS
Munich, Germany) At 15 mo: HEP/ESWT
RCT: Home exercise . CS
program (HEP) v
corticosteroid
injection (CS) v 3
sessions of rESWT
Furia Case- Radial shock wave 66 pts total rESWT: Mean, 51.0 67% female rESWT group: Mean, 12 mo Effective (23)
(2009) control device—Swiss 6 9.9 (range, 18- patients (in both 13.7 6 4.1 (range, Improvements in both
DolorClast, (Electro 71) groups) 80-23) groups, with better
medical systems, Control: Mean, 50.2 Control group: Mean, outcomes in rESWT
Munich, Germany) 6 14.0 (range, 18- 14.0 6 4.3 (range, group
Single treatment 74) 8-22)
session of rESWT v
“additional forms of
nonoperative
treatment” (including
NSAIDs,
physiotherapy)
CS, corticosteroid (injection); ESWT, extracorporeal shockwave therapy (“r”-radial/“F”-focal); F/U, follow-up.

Few serious side effects following ESWT are reported in skin (21%), pain (4.8%), and small haematomas (3%); in
most articles across a range of conditions treated.28 The addition, there was a possibility of ESWT triggering migraine
reported side effects in a placebo-controlled study involving or possible fainting.29 The risk of hematoma was reported
more than 270 patients included transitory reddening of the following the use of a non-musculoskeletal (MSK)–specific

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P.C. Wheeler et al. (2021) Clin J Sport Med

machine, and newer more MSK-specific ESWT devices, which component, and a balance component, with individual programs
seem to have a safer side effect profile.29 A previous case series being set by the participants’ treating physiotherapists. All
involving 45 patients with GTPS treated with ESWT participants had the diagnosis confirmed on either ultrasound
demonstrated that less than 10% developed any bruising, or MRI.
and there were no significant side effects reported following Exclusion criteria included previous or current partial or
ESWT.26 Other patients reported of side effects from the full-thickness tears of the gluteus medius or minimus tendons
NICE guidance for lateral hip/trochanteric pain (IPG 376) (to avoid risk of further injury), those with other known
also reports than in 2% of patients there was increased pain of causes for their pain (such as referred pain or inflammatory/
more than 1 day following ESWT treatment, and skin connective tissue disorders), those unable or unwilling to do
irritation in 33% of patients at 1 month 25 Although the risk the structured rehabilitation program alongside the treatment,
of tendon injury is considered in the NICE guidance,25 this is those who had received a corticosteroid injection within 3
not reported specifically in the previously published articles months, and those on anticoagulation due to the increased risk
investigating the use of ESWT in GTPS, and the absolute risk of bleeding and possible rupture that this may cause.
remains unknown at this time. An a priori power calculation was performed (with power
This study seeks to understand any effect that the addition set at 0.95 and a set at 0.05) using data for improvements in
of 3 weekly sessions of rESWT has for patients with GTPS, self-reported pain as the primary outcome measure from the
when added to a structured rehabilitation process. results of the preliminary study and from other published
research and with a minimum clinical important difference of
between 0.9 and 2.0 points.30–33 This indicated that a
METHODS minimum number of 52 participants in total were needed to
show a measurable effect, based on previously published pre/
Study Outline post differences. Allowing for attrition, initial permissions
were granted to recruit a total of 60 participants, split evenly
This double-blinded randomized controlled trial (RCT) recruited between the intervention and control groups. An in-study
patients who were being treated by the authors in their clinic for power calculation, performed after 2 years with data to that
symptoms of chronic GTPS, who had symptoms for at least 6- point, suggested a smaller than expected difference between
month duration, and who had not received sufficient benefit the groups. Following this, ethical and sponsor permissions
from a HEP over a period of at least 3 months. In this study, were obtained to increase recruitment to a total of up to 120
participants were randomized evenly to 1 of the 2 groups. The participants, submitted through a formal study amendment
first (intervention) group received 3 rESWT sessions performed (IRAS ref 159000.R2).
at weekly intervals using the “recommended dose” of rESWT
from a “Intelect” RPW ESWT machine (DJO Global Chatta-
nooga), with energy level controlled by the operator to the Consent, Randomization, and Masking
“maximally comfortably tolerated dose” for the individual Suitable patients who met the inclusion criteria met with the
patient. The second (control) group received 3 sessions with lead researcher (P.C.W.) during their routine clinical care and
“minimal dose” of rESWT using the lowest possible energy dose had the study outline and aims discussed with them. Patients
from this rESWT machine. The randomization processes, and were provided with written information about the study, as
interventional procedures are described in the relevant sub- well as the NICE patient information leaflet about ESWT for
sections below. In addition to the rESWT members of both GTPS. They were advised that the study was designed to assess
groups received an identical structured HEP, which is described any benefits fromESWT, by comparing 2 different rESWT
below. Patients were encouraged to continue with their HEP “doses,” a “higher-dose” and a “lower-dose.” Following this
throughout the whole duration of their study inclusion. discussion, if they wished to participate in the study, they were
Baseline assessments were conducted before the procedure booked in to commence formal enrollment. In keeping with
using a range of patient-rated outcome measures investigating NHS research guidance, all study participants were given a
aspects of local hip pain/function, global function, mental minimum period of 24 hours between the study being
health, sleep quality, and physical activity; these are described discussed with them and being formally consented to enter
below. The study follow-up duration was 6 months, with the study using signed written consent forms. As this study
interim data recorded at 6 weeks, and 3 months. All patients was open to patients seen in routine NHS clinics by the
were reviewed by clinicians blinded to treatment group. researcher who assessed potential suitability based on in-
clusion and exclusion criteria, a formal screening log was not
kept for this study.
Participants
At enrollment, after consent was taken, participants were
This study was open to patients who were being treated for randomized to intervention or control group by a study nurse
symptoms of GTPS in an NHS secondary care sports medicine/ practitioner who also conducted the rESWT sessions and
musculoskeletal clinic. Patients were required to meet the afterward remained independent from the remainder of the
following inclusion criteria: aged older than 18 years at time of study. Participants were allocated equally to either an
enrollment, to have had pain for at least 6-month duration, to “intervention” group (who received 3 treatment sessions of
have had their pain reproduced on palpation of the greater “recommended-dose” rESWT) or a “control” group (who
trochanter, with their pain reproduced on either resisted external received 3 treatment sessions of “minimal-dose” rESWT)
rotation or resisted abduction of the hip in a side-lying position. using the “Sealed Envelope” software (www.sealedenvelope.
Patients were required to have tried a structured rehabilitation com, ©Sealed Envelope Ltd).
program over a minimum of 3-months; this included a Steps were taken during the rESWT procedure to blind
mobilization and stretch-based component, a strengthening participants to treatment group allocation, and these are

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discussed in the following section. Only the clinician tightness. Participants were recommended to undertake the
administering the rESWT (study nurse practitioner) was stretches 3 times per day, gradually lengthening the time that
aware of group allocation and who subsequently remained positions were held for as tolerated by the participant, aiming to
independent during the remainder of the study period. The build up to 3 sets of each stretch, 3 times per day, holding each for
study participants were reviewed subsequently in clinic, where 30 seconds. The strengthening component used a once/daily
follow-up data were recorded, by clinicians who were blinded concentric–eccentric approach addressing hip abductor and
to group allocation throughout their involvement in the study. external rotator strength (eg, side-lying adduction and clam
Participants completed final data at the 6-month point, and exercises) and other exercises such a double-leg bridge or sit-
the completion of this final data set marked their individual stand exercises as tolerated by the participant. These commenced
completion of the study. They consulted with the lead with the number of repetitions that the participant was able to do
investigator (P.C.W.) after these data were collected, their with only subjective mild discomfort, with a gradual increase
progress was assessed, and only after this point did patient week by week as they were able. The balance component started
unblinding occur. No accidental unblinding occurred during with single-leg balance with eyes open, with a progression to eyes
the study period. closed and then an unstable surface and single-leg minidips were
also added for participants if they progressed that far. The
technique of the participants was checked at the interim
Interventions
appointments by their treating clinicians, and any necessary
Members of both the intervention and the control groups corrections to the technique were made to optimize rehabilita-
undertook 3 sessions of rESWT, which was performed once tion. All study participants were also given written material to
per week for 3 weeks using an “Intelect” RPW ESWT machine support the use of this HEP and to progress the rehabilitation as
(DJO Global Chattanooga) administered by a single practi- their individual symptoms allowed. Participants were instructed
tioner following a standardized protocol. The treatment to recommence the structured HEP as tolerated from the evening
protocol was for rESWT delivered at a frequency of 20 Hz of each ESWT session and to continue this throughout the
with 2000 shocks per treatment session, with the level of duration of the study period.
energy differing between the intervention and control groups.
The intervention group had rESWT performed following
the manufacturer’s representative recommendations, and that Outcome Measures
the “energy dose” from the generated pressure wave
All study participants completed a structured questionnaire
(measured in bar), it should be controlled by the operator to
about their symptoms at baseline (up to 24 hours before
use a “maximal comfortably tolerated” level, rather than a
single specified pressure setting. This level was individual for their treatment commenced) and at the 6-week, 3-month,
different patients and varied between sessions depending on and the final/6-month follow-up visits after their final
comfort. In this study, the mean value of the pressure waves (third) rESWT procedures. This questionnaire contained a
generated in the intervention group was 2.3 6 0.3, 2.8 6 0.3, series of different outcome measures, including questions
and 3.3 6 0.4 bar for the first, second, and third treatment about pain including the pain felt by the patient “on
sessions, respectively. average,” “at its best,” and “at its worst” using a 0 to 10
The members of the control group received a “minimal pain numerical rating scale. In addition, this questionnaire
dose” rESWT, using the lowest practical settings from this contained a number of validated PROMs covering a wide
commercially available rESWT machine. This minimal dose range of aspects of function. These included PROMs
rESWT used a frequency of 20.0 Hz (same as intervention investigating local hip function using the Oxford hip score
group), with 500 shocks per treatment (as opposed to 2000 in (OHS),34,35 the non-arthritic hip score (NAHS),36,37 and
the intervention group) and a 1.4 bar pressure (approximately the GTPS version of the Victorian Institute of Sport
half that of the intervention group.) assessment questionnaire (VISA-G).38 In addition, a range
Participants were blinded in both groups as to the strength of other measures were used including a measure of global
the rESWT that they received. Before treatment, participants function (EQ-5D-5L),39,40 an assessment of the possibility
were advised that the sensation felt during rESWT by individuals of neuropathic pain (painDETECT) or “Central Sensitisa-
was very variable. In both groups, the study participants’ views tion” (CSI),41,42 and assessments of the impact of symptoms
of the rESWT device were obscured by patient positioning and of other specific domains of patient functioning, including
efforts made by the administrator to obscure the strength of the measures of anxiety and depression symptoms (hospital
rESWT delivered by asking the patients throughout about the anxiety and depression scale)43,44 and sleep quality
comfort levels and altering/appearing to alter the settings on the [Pittsburgh sleep quality index(PSQI)].45–47 Physical activ-
rESWT machine throughout the treatment based on patient ity was assessed with the short-form (7-day recall) version
responses. of the International Physical Activity Questionnaire (IPAQ)
48
The after-care following each of the rESWT sessions of both and 2 “vital signs” physical activity questions.49
groups, including initial advice, use of analgesia, and the HEP The primary outcome measure was the between-group
given, was identical. At baseline, before rESWT was carried out, changes in self-reported “average pain” (as recorded on a 0-10
all participants were taught how to perform and progress their numerical rating scale) between baseline and 6 months, with the
HEP by the lead clinician. This rehabilitation program included a remainder of the outcome measures being secondary to this.
mobilization and stretch-based component, a strengthening Those participants who believed that they had not improved
component, and a balance component. The mobilization sufficiently (self-rated) at the 6-month point were offered further
component of the rehabilitation program addressed the range treatment if they wished after the final study follow-up. These
of movement of the hip and low back, addressing hip flexor, included choices between the higher “dose” of rESWT (for those
iliotibial band/tensor fascia latae (ITB/TFL), and hamstring who were in the control group) or options such as surgical

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P.C. Wheeler et al. (2021) Clin J Sport Med

consideration depending on clinical reasoning and patient set of follow-up data for them. A small number of interim
preferences. appointments were missed due to participant availability, staff
availability including unexpected staff absence due to sickness, or
administrative errors. Participant numbers were as follows:
Statistical Analysis baseline n 5 120, of whom, 119 completed all 3 treatment
Data are presented as mean 6 SD. Data were collated sessions, 6 weeks, n 5 117/120 (98%), 3 months n 5 115/120
prospectively into an Excel spreadsheet (MS Excel from MS (96%), and 6 months n 5 117/120 (98%). Information for study
Office 2011, version 14.5.7) and analyzed using SPSS (IBM recruitment is detailed in the included CONSORT 2010 Flow
SPSS Statistics, version 24). Comparisons were made between Diagram (Figure 1).
the data at baseline and each of the posttreatment time points. The mean age of the participants at baseline was 60.6 6
Most of the outcome measures in this data set are scale data. 11.5 years; 82% of participants were female. The participants
All data were analyzed on an intention-to-treat basis, regard- had a mean duration of symptoms of 45.4 6 33.4 months
less of how well the participants had reported that they had (range, 6 months to 30 years); there was a median symptom
conducted their rehabilitation program alongside the specific duration of 24 months, with 27 of 120 participants (23%)
ESWT administered. having had symptoms for 5 years or longer, and 13 of 120
As the sample sizes were small, the Shapiro–Wilk test was participants (11%) having had symptoms for $10 years.
used to assess normality. Parametric testing was undertaken There were no significant differences in any of the de-
for data that were found to be normally distributed, with mographics recorded between participants in the intervention
nonparametric testing for data that were not normally and control groups (Table 2).
distributed. Either unpaired T tests or Mann–Whitney U tests Before inclusion, all patients had previously undertaken a
were used to compare data at baseline to ensure that groups HEP, and all had tried regular analgesia. Participants had
were comparable. Additional x2 testing was performed for received a mean of 0.65 6 0.97 steroid injections before
categorical data. A 2-way repeated-measures analysis of rESWT (range, 0-12 injections), with a mean of 2.66 6 6.13
variance (ANOVA) (time 3 treatment group allocation) was weeks of benefit reported from their last injection (range, 0-52
performed to assess if a significant time 3 group interaction weeks benefit). All participants had undergone either an
effect occurred between baseline and the final (6-month) and ultrasound assessment (n 5 115/120) or MRI (n 5 62/120)
also at the different interim time points, which is widely before rESWT, and in addition, 33% of participants had also
considered to be robust to manage data that do not conform to received an x-ray in the 3 months preceding the rESWT (n 5
normal distribution. As secondary outcome measures, addi- 40/120).
tional tests (either paired-samples T tests or related-samples There were no differences found in any of the baseline pain/
Wilcoxon signed rank tests) were used for specific within- stiffness scores or baseline PROMs studied between the 2
groups comparisons at specific follow-up time-points versus groups. The baseline and follow-up values for the different
baseline. Statistical significance was set at P , 0.05. Missing parameters studied for the participants in the intervention and
value analysis was not undertaken. control groups are displayed in Table 3 for the primary
outcome measure of the self-reported “average level of pain,”
plus the values for the “pain at its worst” and “average
Ethical Considerations stiffness,” using the same 0 to 10 numerical self-rating scale. A
number of secondary outcomes were studied examining the
This study had all necessary permissions and was registered on aspects of hip function, global function, mental health
a publicly accessible database before commencement (Clin- function, sleep, and activity.
icalTrials.Gov identifier NCT02546128). The study was The specific values for members of the intervention and
given a favurable opinion from an NHS Research Ethics control groups are displayed in Table 3 (pain, stiffness, and
Committee (REC ref 15/EM/0122) and had all required local hip-specific PROMS), Table 4 (PROMs assessing wider
site approvals. Ongoing reporting to, and monitoring by, the aspects of function), and Table 5 (PROMs measuring aspects
host Sponsor (UHL NHS Trust) was undertaken. (UHL study of physical activity). These tables give baseline and follow-up
id 11401/EDGE ref 41336). values for the different PROMS used, as well as displaying the
time 3 group significance value at each time point (2 3 2
ANOVA P value displayed) and highlighting any specific
RESULTS
within-group changes of statistical significance.
A total of 120 participants with chronic GTPS commenced The between-group analyses showed no statistically signifi-
involvement in this study having met the formal inclusion/ cant time 3 group interaction effects identified for any of the hip
exclusion criteria. One participant (in the intervention group) PROMs or measures of self-reported pain or stiffness. These
who was found to have marked hypersensitivity to touch on included the results at 6 months for the measures of self-reported
examination withdrew after the first treatment session due to “average pain” (P 5 0.841), “worst pain” (P 5 0.490), or
pain from the procedure, the other 119 of the 120 participants “average stiffness” (P 5 0.621). Additionally, there were no
completed the 3 sessions of rESWT as expected. Of the 120 differences found with the 3 validated hip PROMS that were
patients, 117 (98%) completed the final 6-month follow-up as used: VISA-G score (P 5 0.771) the total score of the NAHS (P 5
expected. One participant in the intervention group and 1 0.118), or the Oxford hip scale (P 5 0.065). However, there were
participant in the control group chose to withdraw from the statistically significant improvements seen in members of the
study after the 6-week period due to external life pressures. intervention group and the control group from the within-group
Despite attempts to persuade them to stay within the study, they analyses for all of the different hip-related measures that were
ceased attending and did not complete further questionnaires. examined at all time points studied and compared with baseline
Both patients were withdrawn from data analysis after the latest values (Table 3).

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Figure 1. CONSORT flowchart for rESWT RCT study.

The PROMS assessing aspects of neuropathic pain, CSI, of sleep quality using the PSQI in both intervention and
mental health, or global function have shown inconsistent control groups for all study periods, except for the control
improvements in some scores in some groups at some time group at 6 weeks. However, there were no differences of
point, with potentially a greater number of more significant significance found between the 2 groups at any time point
findings at 6 months than at earlier periods (Table 4). There studied using a time 3 group analysis for any of these
were statistically significant improvements in the assessment PROMs.

TABLE 2. Demographic Information for Study Participants

Intervention Group (“Recommended Dose” rESWT)
(n 5 57) Control Group (“Minimal Dose” rESWT) (n 5 63) P
Age (yr) 61.7 6 12.3 60.0 6 10.8 0.422
Gender (male/female) 8M/49F (86% female) 15M/48F (76% female) 0.173
Symptom duration (mo) 50.1 6 62.9 41.2 6 43.3 0.366
Data shown are mean 6 SD.

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P.C. Wheeler et al. (2021) Clin J Sport Med

TABLE 3. Local Hip Pain and Function Scores at Baseline and Follow-up
Baseline 6 wk 2 3 2, P 3 mo 2 3 2, P 6 mo 232P
“Average pain” (0-10)
I 6.7 6 1.5 5.0 6 2.4*** 0.959 4.7 6 2.6*** 0.686 4.6 6 2.8*** 0.841
C 6.1 6 1.8 4.5 6 2.4*** 4.4 6 2.7*** 4.0 6 2.7***
“Pain at its worst” (0-10)
I 8.0 6 1.4 6.9 6 2.4*** 0.115 6.2 6 2.5*** 0.933 6.0 6 2.8*** 0.490
C 7.9 6 1.6 5.9 6 2.7** 6.0 6 2.7*** 5.5 6 3.1***
“Average stiffness” (0-10)
I 5.0 6 2.7 4.1 6 2.6** 0.611 3.7 6 2.6*** 0.890 4.0 6 2.8** 0.621
C 4.8 6 2.8 3.6 6 2.7** 3.4 6 2.5** 3.5 6 2.7***
VISA-G
I 45% 6 18% 53% 6 17%** 0.760 55% 6 20%** 0.940 55% 6 22%** 0.771
C 50% 6 16% 57% 6 19%* 61% 6 19%*** 62% 6 20%***
NAHS (total)
I 43.6 6 12.9 46.9 6 13.2* 0.214 51.2 6 14.2** 0.247 49.9 6 15.4** 0.118
C 42.6 6 11.9 50.3 6 16.5** 54.2 6 13.7*** 54.6 6 16.1***
OHS
I 25.1 6 8.1 27.9 6 8.8** 0.162 30.8 6 9.1** 0.336 29.9 6 9.2** 0.065
C 25.1 6 7.9 31.1 6 9.8*** 33.0 6 9.0*** 34.1 6 9.2***
Figures shown are mean 6 SD. I is“intervention group” (ie, “recommended dose” rESWT n 5 57, n 5 55/57 at 6 weeks, n 5 55/57 at 3 months, n 5 55/57 at 6 months); “C” is “control
group” (ie, “minimal dose” rESWT, n 5 63, n 5 62/63 at 6 weeks, n 5 60/63 at 3 months, n 5 62/63 at 6 months). Statistical significance was calculated between data at baseline and the
different follow-up time-points, respectively, comparing intervention and control groups using 2 3 2 (time 3 group) ANOVA testing (P value displayed.) Within-group comparisons between
baseline and follow-up time points was undertaken using either paired t-tests or Wilcoxon tests, and statistical significance is denoted by the use of asterisks within that row (*P , 0.05, **P ,
0.01, ***P , 0.001). VISA-G (Victoria Institute of Sport—Gluteal score) % scale: higher score indicating better function. NAHS (non-arthritic hip score) total score range 0 to 80: higher score
indicates better function. OHS (Oxford hip scale) scale 0 to 48: higher score indicating better function.

Despite the improvements in pain seen in both groups using included in a recent multicenter study examining the demograph-
the within-group analyses, there were no significant changes in ics of patients presenting to routine NHS care for symptoms of
levels of moderate or physical activity for either group as assessed GTPS, which found that there was an average age of 59.4 6 13.7
by the short-form IPAQ, or overall active minutes as assessed by years, with 73% subjects being female, an average duration of
the “Vital signs” questions. There was a statistically significant symptoms in excess of 12 months, and an average (0-10) pain
increase in the amount of walking undertaken at 6 weeks score of 6.5 6 2.1.5
compared with baseline in the intervention group (baseline: 306
6 617; 6 weeks: 411 6 693; P 5 0.015) and at 3 and 6 months in
the control group (baseline: 270 6 427; 3 months: 406 6 529; P Within-Group Analysis
5 0.0.021; 6 months: 433 6 720; P 5 0.010). However, as there
A number of significant within-group improvements were seen in
were no differences found between the groups with the time 3
both groups comparing baseline with different follow-up time
group ANOVA testing, any significance of these individual
points for a range of the outcome measures that were studied.
within-group changes remains limited (Table 5).
This included statistically significant improvements in pain
The side effect profile of the rESWT was very favorable.
(“average” pain and “worst” pain) as well as validated pain
Two participants in each group (3.4% total, 3.5% interven-
and function PROMs including VISA-G, NAGS, and OHS. Sleep
tion group, and 3.2% control group) reported minor bruising quality as assessed by PSQI was also improved in both groups
from the rESWT after their treatment, but this did not following rESWT. Fewer improvements were seen in PROMs
preclude them receiving the planned rESWT. No participants that assessed wider aspects of function including mood (HAD,
in either group reported any significant erythema, numbness, PHQ-4, GAD-7, PHQ-9) or overall percent health (EQ-5D).
or increased stiffness after any of the rESWT sessions. No There were no consistent improvements in levels of physical
significant untoward events, such as tendon rupture, were activity as assessed by IPAQ or “vital signs” questions in either
reported throughout the study period. group following treatment.

DISCUSSION Between-Group Analysis

This study has used a pragmatic approach to study inclusion There were no time 3 group interaction effects found between
which endeavored to facilitate study enrollment in all suitable the groups at any of the follow-up periods, for any of the
patients referred to this secondary care clinic, giving a “real- outcome measures studied. This indicates that 3 sessions of
world” situation and facilitating translation of results from this to shockwave therapy performed at weekly intervals at the
other similar clinics. The demographics of the patient population “recommended dose”, with an “Intelect” RPW ESWT machine
presenting in this study are very similar to those who were (DJO Global Chattanooga) had no measurable benefit over a

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TABLE 4. Patient-Rated Outcome Measures at Baseline and Follow-Up Assessing Wider Aspects of
Functioning
Baseline 6 wk 2 3 2, P 3 mo 2 3 2, P 6 mo 2 3 2, P
painDETECT
I 12.4 6 7.0 10.4 6 5.7* 0.796 9.5 6 5.7** 0.939 9.8 6 6.2** 0.771
C 10.8 6 7.4 9.2 6 6.4 8.0 6 5.8* 8.7 6 6.8*
CSI
I 33% 6 16% 30% 6 16%** 0.626 27% 6 15%*** 0.918 28% 6 17%*** 0.983
C 31% 6 15% 30% 6 16%* 25% 6 15%** 26% 6 17%**
ODI
I 39% 6 17% 35% 6 18%** 0.551 30% 6 19%*** 0.700 32% 6 20%** 0.656
C 34% 6 14% 28% 6 17%** 27% 6 17%* 25% 6 17%***
EQ-5L %health
I 67% 6 17% 71% 6 17% 0.503 70% 6 20% 0.481 66% 6 23% 0.187
C 70% 6 17% 70% 6 18% 69% 6 22% 75% 6 15%*
HAD—anxiety subscale
I 6.1 6 3.8 5.3 6 3.8** 0.685 4.6 6 3.8** 0.932 4.5 6 3.8** 0.544
C 5.4 6 3.7 5.0 6 3.7 4.0 6 3.5** 4.5 6 4.1*
HAD—depression subscale
I 5.3 6 3.3 5.1 6 4.0 0.660 4.0 6 3.5* 0.902 3.9 6 3.5** 0.646
C 4.9 6 3.7 4.3 6 3.8 3.8 6 3.3* 3.9 6 3.6*
PHQ-4
I 1.8 6 2.1 1.7 6 2.1 0.670 1.2 6 2.2 0.667 1.5 6 2.2 0.665
C 1.6 6 2.4 1.7 6 2.5 1.2 6 2.0 1.5 6 2.1
GAD-7
I 4.1 6 3.8 3.6 6 3.7 0.760 2.8 6 3.7* 0.822 3.2 6 3.8 0.651
C 3.8 6 4.3 3.7 6 4.2 2.7 6 3.2 3.4 6 4.2
PHQ-9
I 5.4 6 4.6 5.6 6 5.3 0.726 4.3 6 4.9 0.944 4.7 6 4.8 0.880
C 5.2 6 4.8 4.9 6 5.8 4.1 6 4.3 * 4.7 6 5.1
PSQI (total score)
I 10.1 6 4.1 9.6 6 4.2* 0.912 9.3 6 4.7* 0.692 9.3 6 4.6* 0.541
C 11.0 6 4.3 10.4 6 4.6 9.7 6 4.5** 9.4 6 4.8***
Roles–Maudsley score
I . 3.2 6 0.8*** 2.8 6 0.9*** 2.9 6 1.1***
C . 2.9 6 1.0*** 2.8 6 1.0*** 2.7 6 1.1***
Figures shown are mean 6 SD. I is “intervention group” (ie, “recommended dose” rESWT n 5 57, n 5 55/57 at 6 weeks, n 5 55/57 at 3 months, n 5 55/57 at 6 months); “C” is “control
group” (ie, “minimal dose” rESWT, n 5 63, n 5 62/63 at 6 weeks, n 5 60/63 at 3 months, n 5 62/63 at 6 months). Statistical significance was calculated between data at baseline and the
different follow-up time-points, respectively, comparing intervention and control groups using 2 3 2 (time 3 group) ANOVA testing (P-value displayed.) Within-group comparisons between
baseline and follow-up time points was undertaken using either paired t-tests or Wilcoxon tests, and statistical significance is denoted by the use of asterisks within that row (*P , 0.05, **P ,
0.01, ***P , 0.001).
Specific questionnaires: painDETECT—range 0 to 38, with lower score indicating lower likelihood of neuropathic pain). CSI—%scale, lower score indicates lower likelihood of central pain
component). ODI—(%scale, lower score indicates less self-rated disability pain. EQ-5D—health %scale, higher score indicates better self-rated global health). HAD—anxiety/depression
subscales, each range 0 to 21, with lower score indicating fewer symptoms. PHQ-4—(range 0-12, with lower score indicating fewer symptoms). GAD-7—(range 0-21, with lower score
indicating fewer anxiety symptoms). PHQ-9—(range 0-27, with lower score indicating fewer depressive symptoms). PSQI—(range 0 to 21, with lower score indicating fewer symptoms of
sleep disturbance. Roles–Maudsley score—converted to 1 to 4 score, with higher score being better function/fewer symptoms.

“minimal dose” rESWT protocol, which used one-quarter of the rESWT at “recommend dose” or “minimal dose” are not clear at
number of shocks at about half of the pressure (approximately this time. However, this RCT has raised significant questions as to
one-eighth of the “dose”) for patients with chronic GTPS. the effectiveness of rESWT for this condition because it has shown
The lack of any time 3 group interaction effect between the no differences between the intervention and the control groups.
intervention and control groups in this RCT means that the
significant improvements (at 6 weeks, 3 months, and 6 months)
that are seen with the within-group analyses are not arising from Considerations
the level of energy delivered by the rESWT. The reasons for the The within-group improvements seen in both the intervention
lack of differences in outcomes following either 3 sessions of and control groups in this study could have arisen from the

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P.C. Wheeler et al. (2021) Clin J Sport Med

TABLE 5. Patient-Rated Outcome Measures at Baseline and Follow-up Assessing Levels of Physical
Activity
Baseline 6 wk 2 3 2, P 3 mo 2 3 2, P 6 mo 2 3 2, P
IPAQ—no. of vigorous–level activity min/wk
I 65 6 285 87 6 334 0.839 74 6 337 0.456 76 6 288 0.413
C 61 6 270 69 6 150 134 6 388 137 6 358
IPAQ—no. of moderate-level activity min/wk
I 52 6 125 107 6 464 0.529 147 6 436 0.455 40 6 82 0.207
C 102 6 309 106 6 245 136 6 286 181 6 410
IPAQ—no. of walking min/wk
I 306 6 617 411 6 693* 0.954 357 6 536 0.543 281 6 376 0.195
C 270 6 427 383 6 565 406 6 529* 433 6 720*
IPAQ—no. of hours sitting on a weekday
I 5.3 6 3.7 4.7 6 3.8 0.573 5.1 6 6.4 0.865 5.3 6 4.0 0.546
C 4.7 6 3.3 4.6 6 3.4 4.7 6 2.1 4.2 6 2.9
“Vital signs”—active minutes per week
I 141 6 350 150 6 512 0.982 144 6 364 0.859 92 6 295 0.337
C 134 6 316 146 6 314 153 6 366 169 6 361
Figures shown are mean 6 SD. I is “intervention group” (ie, “recommended dose” rESWT n 5 57, n 5 55/57 at 6 weeks, n 5 55/57 at 3 months, n 5 55/57 at 6 months); “C” is “control
group” (ie, “minimal dose” rESWT, n 5 63, n 5 62/63 at 6 weeks, n 5 60/63 at 3 months, n 5 62/63 at 6 months). Statistical significance was calculated between data at baseline and the
different follow-up time-points, respectively, comparing intervention and control groups using 2 3 2 (time 3 group) ANOVA testing (P-value displayed.) Within-group comparisons between
baseline and follow-up time points was undertaken using either paired t-tests or Wilcoxon tests, and statistical significance is denoted by the use of asterisks within that row (*P , 0.05, **P ,
0.01, ***P , 0.001).

rehabilitation itself, and/or the impact of time. However, the However, given that this is a medical device, that is licensed for
likelihood of these factors having a significant impact is this indication and the necessary steps that the manufacturer
unknown because all patients in both groups had previously has undertaken to obtain these required licenses, it is unclear if
undertaken rehabilitation before rESWT and had a mean this is likely. A robust comparative study between 2 different
duration of symptoms of nearly 4 years. These factors rESWT machines may however seek to address this
however cannot be ruled out and must be given consideration consideration.
given the lack of differences in outcomes seen between the A possibility is that the “minimal dose” rESWT that was
intervention and control groups. Other possibilities could chosen as a comparator was itself of a therapeutic effect.
include that rESWT as a treatment modality is not effective in Overall, the treatment used in the control group used one-
patients with chronic GTPS, that this specific rESWT machine quarter of the number of shocks administered in the in-
is ineffective, that the “minimal dose” rESWT was sufficient to tervention group, which was performed at about half of the
create the improvement seen with rESWT, or that 3 sessions of strength of pressure wave, and following this treatment, there
rESWT is insufficient and that further treatment sessions are were a number of within-group improvements seen in the
required. Each of these possibilities are briefly considered control group when comparing baseline and follow-up data.
below. The “minimal dose” regimen used the lowest possible settings
There is very limited published evidence for the use of from this commercially available rESWT machine as a
ESWT in patients with GTPS to draw comparison with. A pragmatic comparison group that facilitated patient blinding
single unblinded RCT has compared radial shockwave of treatment group allocation. It is possible that this still had a
therapy, a HEP, and corticosteroid injections for patients therapeutic effect, although this cannot be confirmed from this
with GTPS.3 This study demonstrated greatest success at 1 study design. An option to explore this further would be to use
month in the group who received the corticosteroid injection, a rESWT with acoustic shielding between the transmitter head
but at 4 months, the results favored rESWT, and at 15 months, and the patient or an alternative study methodology could be
the results of both rehabilitation and shockwave outper- to compare outcomes following rESWT plus rehabilitation in
formed those seen following corticosteroid injections. The this clinical population with chronic symptoms to a group
only other published research involving the use of rESWT in receiving rehabilitation only and run a study as a single blind
patients with GTPS includes either case–control23 or case (observer blinded) only.
series studies only.24,26 It may be that rESWT is ineffective as a An alternative possibility for the lack of effectiveness seen in
treatment modality in patients with chronic GTPS, and more this study was the specific rESWT regimen itself. The advice
research is required to address this. Furthermore, this is the received from the manufacturer was that the treatment was a
first study to have published results comparing active total of 3 sessions performed on a weekly basis, at the patient’s
treatment with this specific rESWT machine compared with “maximal comfortably tolerated dose.” However, the evidence
another (potentially active) treatment, and it is at least behind these specific recommendations is unclear, particularly
theoretically possible that this machine is less effective than with regards to patients with GTPS rather than other tendon
other rESWT machines that have been used in other studies. conditions and uncertainties remain as to the number of rESWT

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