Original research
Is radial extracorporeal shock wave therapy (rESWT),
► Additional supplemental
material is published online
only. To view, please visit the
journal online (https://​doi.​
org/1​ 0.​1136/​bjsports-​2024-​
108139).
1
Institute of Clinical Medicine,
Faculty of Medicine, University
of Oslo, Oslo, Norway
2
Department of Physical
Medicine and Rehabilitation,
Oslo University Hospital, Oslo,
Norway
3
Oslo Centre for Biostatistics
and Epidemiology, Oslo
University Hospital, Oslo,
Norway
4
Norwegian Olympic and
Paralympic Committee and
Confederation of Sports, Oslo,
Norway
Correspondence to
Dr Marte Heide, University of
Oslo Faculty of Medicine, Oslo,
0372, Norway;
​marte.​heide@m​ edisin.​uio.n​ o
Accepted 5 June 2024
© Author(s) (or their
employer(s)) 2024. Re-­use
permitted under CC BY-­NC. No
commercial re-­use. See rights
and permissions. Published
by BMJ.
To cite: Heide M,
Røe C, Mørk M, et al.
Br J Sports Med Epub ahead
of print: [please include Day
Month Year]. doi:10.1136/
bjsports-2024-108139
sham-­rESWT or a standardised exercise programme
in combination with advice plus customised foot
orthoses more effective than advice plus customised
foot orthoses alone in the treatment of plantar
fasciopathy? A double-­blind, randomised, sham-­
controlled trial
Marte Heide ‍ ‍,1,2 Cecilie Røe,1,2 Marianne Mørk,1,2 Kjersti Myhre,2
Cathrine Brunborg,3 Jens Ivar Brox,1,2 Aasne Fenne Hoksrud4
ABSTRACT
Objectives To assess whether radial extracorporeal
shock wave therapy (rESWT), sham-­rESWT or a
standardised exercise programme in combination
with advice plus customised foot orthoses is more
effective than advice plus customised foot orthoses
alone in alleviating heel pain in patients with plantar
fasciopathy.
Methods 200 patients with plantar fasciopathy
were included in a four-­a rm, parallel-­group, sham-­
controlled, observer-­blinded, partly patient-­blinded
trial. At baseline, before randomisation, all patients
received advice plus customised foot orthoses.
Patients were randomised to rESWT (n=50), sham-­
rESWT (n=50), exercise (n=50) or advice plus
customised foot orthoses alone (n=50). Patients in
the rESWT and sham-­rESWT groups received three
treatments. The exercise programme comprised
two exercises performed three times a week for 12
weeks, including eight supervised sessions with a
physiotherapist. Patients allocated to advice plus
customised foot orthoses did not receive additional
treatment. The primary outcome was change in
heel pain during activity in the previous week per
Numeric Rating Scale (0–10) from baseline to
6-­month follow-­up. The outcome was collected at
baseline, and 3, 6 and 12 months.
Results The primary analysis showed no statistically
significant between-­group differences in mean
change in heel pain during activity for rESWT versus
advice plus customised foot orthoses (−0.02, 95%
CI −1.01 to 0.96), sham-­rESWT versus advice plus
customised foot orthoses (0.52, 95% CI −0.49 to
1.53) and exercise versus advice plus customised
foot orthoses (−0.11, 95% CI −1.11 to 0.89) at 6
months.
Conclusion In patients with plantar fasciopathy,
there was no additional benefit of rESWT, sham-­
rESWT or a standardised exercise programme over
advice plus customised foot orthoses in alleviating
heel pain.
Trial registration number NCT03472989.
Heide M, et al. Br J Sports Med 2024;0:1–9. doi:10.1136/bjsports-2024-108139
Br J Sports Med: first published as 10.1136/bjsports-2024-108139 on 20 June 2024. Downloaded from http://bjsm.bmj.com/ on June 27, 2024 by guest. Protected by copyright.
WHAT IS ALREADY KNOWN ON THIS TOPIC
⇒ Plantar fasciopathy is a common condition.
Previous reviews and meta-­analyses have not
concluded that one treatment is superior to
another.
⇒ A recent best practice guide proposed a
stepped management strategy with a core
approach including education, taping and
stretching of the plantar fascia. In cases of
suboptimal improvement, additional radial
extracorporeal shock wave therapy (rESWT) and
custom orthoses were suggested.
WHAT THIS STUDY ADDS
⇒ In patients with plantar fasciopathy who
received advice and customised foot orthoses,
this randomised controlled trial (RCT) showed
no additive effects of rESWT, sham-­rESWT
or a standardised exercise programme over
advice plus customised foot orthoses alone in
alleviating heel pain.
HOW THIS STUDY MIGHT AFFECT RESEARCH,
PRACTICE OR POLICY
⇒ The results indicate that adding rESWT, sham-­
rESWT or exercises in addition to advice plus
customised foot orthoses does not improve
heel pain for patients with plantar fasciopathy.
Research focusing on evaluating and optimising
the content and delivery of advice, the use of
foot orthoses and RCT’s including ‘a wait and
see’ control arm to gain more evidence on the
natural course of the condition are warranted.
INTRODUCTION
Plantar fasciopathy is a degenerative condition
characterised by under-­surface heel pain1 that can
cause exercising or walking during daily activities
to be challenging. Plantar fasciopathy has been
reported to affect 3.6%–9.6% of the population2–4
   1
 Original research
and is associated with psychological stress and reduced health-­
related quality of life.5–8 It is assumed that plantar fasciopathy
resolves over time, but reported recovery times vary from several
months to years.9 Previous systematic reviews and meta-­analyses
comparing the effectiveness of common treatment approaches
have not drawn firm conclusions regarding the optimal manage-
ment strategy for this condition.10 11 A recent best practice guide
by Morrissey et al suggested a core approach including taping,
plantar fascia stretching and individualised education consisting
of advice on pain, load management, proper footwear and
avoiding barefoot walking. For patients progressing slowly or
inadequately, extracorporeal shock wave therapy (ESWT) and
custom orthoses were recommended.12 However, the optimal
insole type and the therapeutic effect of orthoses in the treat-
ment of plantar fasciopathy remain uncertain.13 14
Radial ESWT (rESWT) is a widely used non-­invasive treatment
with few registered harms. This modality has been reported to
be more effective than sham-­rESWT for treating plantar fasci-
opathy,15 16 though the methodological limitations of previous
trials highlight the necessity for additional high-­quality studies to
determine if rESWT is an ideal therapeutic method, particularly
for the long-­term resolution of symptoms.12 17
Recent research has shown high-­ load strength training or
heavy-­slow resistance training (HSR) to have promising effects
on pain and function in the treatment of Achilles and patellar
tendinopathy.18 19 Researchers have proposed that this exercise
method may reduce structural abnormalities, such as hypoechoic
areas, irregular structures, neovascularisation and tendon thick-
ening.20 Few trials, however, have assessed the effectiveness of
high-­load strength training in treating plantar fasciopathy. In a
study by Rathleff et al, high-­load strength training was found
to be more effective than stretching after 3 months, though
there was no difference between the groups after 12 months.21
A recent three-­armed RCT by Riel et al found no clinically rele-
vant between group differences after 12 weeks comparing advice
and heel cups versus advice, heel cups and HSR training versus
advice, heel cups, HSR and a single cortisone injection. The
results indicated that performing exercises was no better than
not performing exercises.22
The previous finding highlights the need for more trials
comparing rESWT and exercise treatment for plantar fasciopathy.
This trial aimed to assess the effectiveness of rESWT, sham-­
rESWT and a standardised exercise programme in combination
with advice plus customised foot orthoses compared with advice
plus customised foot orthoses alone in alleviating heel pain
(primary outcome) after 6 months in patients with plantar fasci-
opathy. Secondary outcomes measuring function and health-­
related quality of life were explored after 6 and 12 months.23
METHODS
Design
In this randomised controlled trial (RCT) with a four-­ arm
parallel-­group design, participants were blinded to rESWT and
sham-­rESWT treatments but not to other treatments. The trial
was conducted at the Department of Physical Medicine and
Rehabilitation at Oslo University Hospital from March 2018 to
January 2023. The study’s protocol was previously published,23
(online supplemental file 2) and the trial is registered at ​Clini-
calTrials.​gov. The reporting follows the Consolidated Standards
of Reporting Trials guidelines, the Template for Intervention
Description and Replication checklist, the Consensus on Exercise
Reporting Template checklist24–26 and the CHAMP statement.27
2 Heide M, et al. Br J Sports Med 2024;0:1–9. doi:10.1136/bjsports-2024-108139
Participants
Br J Sports Med: first published as 10.1136/bjsports-2024-108139 on 20 June 2024. Downloaded from http://bjsm.bmj.com/ on June 27, 2024 by guest. Protected by copyright.
Patients between 18 and 70 years of age who were referred by
local general practitioners (GPs) to the outpatient clinic for heel
pain were eligible for inclusion in the study. Inclusion criteria
were pain for greater than 3 months localised to the proximal
insertion of the plantar fascia on the medial calcaneal tuberosity
and tenderness to palpation corresponding to the painful area.
Participants had to report a pain intensity during activity in the
previous week on the Numeric Rating Scale (NRS) of 3 or higher,
be residents of Norway and understand oral and written Norwe-
gian. The exclusion criteria were treatment with rESWT within
the last 3 months, spondyloarthropathy or rheumatoid arthritis,
plantar fibromatosis, tarsal tunnel syndrome, polyneuropathy,
previous surgery with osteosynthesis material remaining in the
foot or ankle and presence of contraindications for rESWT (use
of anticoagulant drugs, pregnancy, bleeding disorders, epilepsy
or pacemaker).
Patient and public involvement
Patients were involved in the cross-­ cultural adaption of the
Foot Function Index Revised Short form (FFI-­ RS) outcome
measure.28 Interviews with 15 patients regarding their experi-
ences to live with persistent plantar fasciopathy informed the
present project.6 The results of this RCT have been presented
and discussed with the service-­ user network at the Research
Centre for Habilitation and Rehabilitation Models and Services
(CHARM), University of Oslo.
Randomisation and blinding
After clinical examination and baseline assessments the patients
were randomised to one of the four treatment groups in blocks
of eight in a 1:1 ratio. A researcher not involved in the trial
generated the allocation sequence using a computer-­generated
randomisation schedule which was electronically concealed.
This researcher communicated the allocation to a physiother-
apist (project coordinator) who further communicated the
group allocation to the patients. The patients were blinded for
the rESWT and sham-­rESWT. The same physiotherapist, not
blinded to treatment allocation, delivered the treatments to all
four groups. All other researchers were blinded to group alloca-
tion. To evaluate the success of the blinding procedure, patients
in the rESWT and sham-­rESWT groups were asked after their
final treatment if they believed they had received real or sham
treatments or if they did not know.
Baseline assessments and interventions
During the first visit, all patients underwent a clinical exam-
ination and ultrasound scan performed by one of three physi-
cians.23 The patients completed self-­administered questionnaires
covering sociodemographic and clinical factors and the primary
and secondary outcome measures. After the first visit and before
randomisation, the physiotherapist orally communicated stan-
dardised information on pathogenesis, aetiology and prognosis,
advice to stay physically active within pain tolerance and to use
proper footwear with cushioning. The participants also received
a written handout containing the information (online supple-
mental appendix 1). The patients were then referred to a Certi-
fied Prosthetist/Orthotist (CPO) from Sophies Minde Ortopedi,
who performed a 3D scan of the foot to prepare the customised
foot orthoses. The orthoses were made of a semirigid material
called Comfort-­ Line (online supplemental appendix 1). The
patients were instructed to wear the orthoses as much as possible
and were offered one follow-­ up consultation if the orthoses

required further customisation. The physiotherapist providing
the interventions had over 20 years of experience in treating
patients with lower extremity musculoskeletal disorders. All
patients were asked to refrain from any other treatment during
the trial.
Advice plus customised foot orthoses
Patients randomised to this group received the above described
information and advice, plus customised foot orthoses and had
no other interventions or contacts provided throughout the trial
except for the planned follow-­ups. The intervention is compa-
rable to the treatment we usually provide at the outpatient clinic
for these patients and was labelled ‘usual care’ in the protocol
(online supplemental file 2)23 and in ​ClinicalTrial.​gov.
rESWT/sham rESWT
The rESWT and sham-­rESWT treatments were administered by
the physiotherapist once a week for a total of three treatments,
which is in line with previously suggested treatment protocols
for plantar fasciopathy.29 The sham-­rESWT was administered in
the exact same way as the real rESWT, with the patient lying in a
prone position (online supplemental appendix 1). Details of the
rESWT and sham-­rESWT treatments are reported in the study’s
protocol (online supplemental file 2).23
High-load exercise programme
The exercise programme administered to the patients allo-
cated to the exercise group included two exercises: unilateral
heel raises and unilateral leg squats. Patients in this group were
instructed to perform the exercises three times a week for 12
weeks. The heel raise exercise was performed as in the study
by Rathleff et al using a rolled-­up towel or similar underneath
the toes standing on a stairway or similar location21 and the leg
squad was performed the same way but standing on the floor.
The programme was similarly as reported by Kongsgaard et
al30 slowly progressing throughout the period, starting with 12
repetition maximum (RM) in week 1–3, progressing to 6 RM
in week 9–12. We used three sets per exercise. The details of
the programme are described in the protocol (online supple-
mental file 2).23 Each patient participated in a total of eight
sessions supervised by a physiotherapist at the outpatient clinic.
To increase motivation, self-­ management and adherence, the
patients received a thorough explanation and clear demonstra-
tion of the exercises as well as a written manual for use at home.
They were informed of common side effects, such as muscle
soreness and transient pain. Any barriers to execution were
evaluated and adjustments were provided (online supplemental
appendix 1). Patients were encouraged to record their repeti-
tions, sets, weight load and number of training sessions, which
the physiotherapist monitored to ensure progression (online
supplemental appendix 1).
Outcome measures
Outcomes were assessed at baseline and at 3, 6 and 12 months.
Patients attended baseline, 6-­month and 12-­month follow-­ups
at the outpatient clinic. For the 3-­
month follow-­up, a letter
containing the outcome measures was sent to the patients to
complete and return.
Primary outcome
The primary outcome was patient-­rated heel pain during activity
in the previous week as measured by the NRS (NRSa) at 6
months. The NRS is an 11-­point numeric scale ranging from 0
Heide M, et al. Br J Sports Med 2024;0:1–9. doi:10.1136/bjsports-2024-108139
Original research
(‘no pain’) to 10 (‘worst imaginable pain’).31 In cases of bilat-
Br J Sports Med: first published as 10.1136/bjsports-2024-108139 on 20 June 2024. Downloaded from http://bjsm.bmj.com/ on June 27, 2024 by guest. Protected by copyright.
eral plantar fasciopathy, patients were asked to identify the most
painful heel (right or left), and the same side was assessed at each
follow-­up.
Secondary outcomes and assessments
The secondary outcomes were heel pain at rest in the previous
week (NRSr), RAND-­12 Health Status Inventory (RAND-­12)
score, FFI-­RS score and Patient Global Impression of Change
(PGIC) scale.
The RAND-­12 is a generic patient-­reported outcome measure-
ment (PROM) that evaluates health-­related quality of life. It
consists of 12 questions and generates two scores: the Mental
Component Summary score (MCS12) and the Physical Compo-
nent Summary score (PCS12). Scores range from 0 to 100, with
higher scores indicating better health.32 The FFI-­RS is a region-­
specific PROM that consists of 34 questions with five subscales:
pain, stiffness, difficulty, activity limitations and social issues.
The total score ranges from 0 to 100, with lower scores indi-
cating better foot health.33 We used the translated and validated
Norwegian version of the FFI-­RS.28
Patients’ overall impression of change in their health status
was assessed using a PGIC scale. The patients answered one
PGIC question: ‘Compared with the start of the study, how is
your general health status today?’. Possible responses ranged
from 1 to 7, where 1 was ‘very much better’, 4 was ‘no change’
and 7 was ‘very much worse’.
Sample size calculation
The sample size was calculated based on the primary outcome
measure (NRS) at 6 months, with a comparison between the inter-
vention groups and the control group (three comparisons) with
two-­sided t-­tests. To achieve a power of 90%, significance level
of 5%, assumed mean difference of 2 on the NRS,34 estimated
SD of 2.7 (based on previous clinical data from the Department
of Physical Medicine and Rehabilitation) and dropout of 20%,
the sample size was calculated to be 200, with 50 in each group.
Statistical analysis
A statistical analysis plan was developed in collaboration with a
statistician (CB) and published in C ​ linTrials.​gov before any anal-
yses were performed. All authors remained blinded to treatment
allocation until after the primary analysis at 6-­month follow-­up
had been conducted and the results had been decided on. The
effect analysis used the intention-­ to-­
treat (ITT) population
including all patients in their originally assigned groups, regard-
less of what treatment, if any, they received. The primary and
secondary outcomes were analysed using a linear mixed-­effects
model to account for repeated measures over the follow-­ up
period (baseline and 3, 6 and 12 months). The model included
fixed effects for time and treatment group×time interaction.
Random intercept and slope models were used. Based on this
model, the primary effectiveness outcome of between-­ group
differences in change from baseline to 6-­month follow-­up with
95% CIs was estimated. Within-­group changes from baseline to
6 months were calculated for all treatment groups. Between-­
group differences in mean change over 3, 6 and 12 months were
also estimated. A statistical significance level of 5% was applied.
Post hoc analysis was performed for the PGIC scale using the
Mann-­Whitney U test to assess differences between the groups
at 6 months.
The per-­ protocol analysis included all patients who were
randomised and received treatment without deviating from the
3
 Original research
protocol (for the rESWT/sham-­rESWT treatments, completing inequities regarding gender, race, socioeconomic status or

at least two out of three treatments, and for the exercise
programme, completing at least six out of eight sessions with the
physiotherapist or at least 30 out of 36 exercise sessions), and
outcomes were analysed according to treatment group.
Statistical analyses were performed using IBM SPSS Statis-
tics for Windows V.29 (Armonk, NY: IBM Corp) and Stata V.17
(College Station, TC: StataCorp LLC).
Equality, diversity and inclusion statement
The author team consisted of six women and one man from
different disciplines including junior and senior researchers. We
included all eligible patients regardless of sex, race/ethnicity/
culture and socioeconomic level. The analyses did not consider
Br J Sports Med: first published as 10.1136/bjsports-2024-108139 on 20 June 2024. Downloaded from http://bjsm.bmj.com/ on June 27, 2024 by guest. Protected by copyright.
marginalised groups.
Protocol deviations
Due to the COVID-­ 19 restrictions no inclusions were made
between 12 March 2020 and 24 April 2020 and between 13
March 2021 and 22 April 2021. Six-­ month and 12-­ month
follow-­ups were performed by phone and questionnaires sent by
post in these periods. In the exercise group some of the sessions
with the physiotherapist were done by phone or video and
for two patients rESWT treatment was delayed for 2 months
because of the COVID-­19 restrictions. In the per protocol anal-
ysis timing of follow-­up visits could not be included as a criterion
as stated in the analysis plan, because of deficient registration.

Figure 1 Flowchart of participants included in the study. A & CO, advice plus customised foot orthoses; ITT, intention-­to-­treat; NRS, Numeric Rating
Scale; rESWT, radial extracorporeal shock wave therapy.

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 Original research

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Table 1 Characteristics of patients at baseline in the four treatment groups*
rESWT (n=50) Sham-­rESWT (n=50) Exercise (n=50) A & CO (n=50)
Age, years, mean (SD) 46.3 (11.0) 44.8 (8.5) 42.6 (11.5) 45.4 (11.8)
Sex, female 42 (84) 37 (74) 42 (84) 42 (84)
Cohabitant or married 30 (60) 37 (74) 35 (70) 30 (60)
Current smoker† 4 (8.2) 9 (18) 4 (8.2) 6 (12.2)
Body mass index (kg/m2), mean (SD) 29.9 (5.1) 28.7 (5.3) 28.1 (4.0) 28.2 (5.2)
Bilateral pain 20 (40) 14 (28) 23 (46) 19 (38)
Plantar fascia thickness, mm, affected foot‡, mean (SD) 5.4 (1.6) 5.4 (1.2) 4.9 (1.2) 5.6 (1.4)
Plantar fascia thickness, mm, non-­affected foot, mean (SD) 4.4 (1.0) 4.1 (0.73) 4.1 (0.90) 4.3 (1.0)
Duration of symptoms
 3–6 months 12 (24) 15 (30) 13 (26) 18 (36)
 6–12 months 21 (42) 16 (32) 12 (24) 8 (16)
 12–24 months 6 (12) 7 (14) 11 (22) 11 (22)
 >24 months 11 (22) 12 (24) 14 (28) 13 (26)
Education
 ≤12 years at school 21 (42) 12 (24) 19 (38) 20 (40)
 College/university 29 (58) 38 (76) 31 (62) 30 (60)
 Employed full-­time, part-­time or student 42 (84) 43 (86) 46 (92) 45 (90)
 On sick leave 16 (32) 8 (16) 13 (26) 14 (28)
 Analgesics, daily use§ 8 (16) 6 (12) 6 (12.5) 3 (6)
Physical activity level¶
 Sedentary 9 (18.4) 7 (14) 5 (10.2) 8 (16.7)
 Walking/biking ≥4 hours/week 31 (63.3) 29 (58) 33 (67.3) 29 (60.4)
 Recreational sport ≥4 hours/week 7 (14.3) 13 (26) 6 (12.2) 10 (20.8)
 Exercise/competition 2 (4) 1 (2) 5 (10.2) 1 (2.0)
 Previous treatment** 20 (41) 23 (46) 27 (54) 27 (54)
 Previous rESWT 9 (19) 8 (17) 11 (22) 8 (16)
*Values are numbers (percentages) unless stated otherwise.
†One response missing in radial extracorporeal shock wave therapy (rESWT), one response missing in exercise, one response missing in advice plus customised foot orthoses (A
& CO).
‡In the case of bilateral pain, the most painful heel was reported as the affected foot.
§Two responses missing in exercise, one response missing in A & CO.
¶One response missing in rESWT, one response missing in exercise, two responses missing in A & CO.
**Previous treatment included the following: training with a physiotherapist, other treatment with a physiotherapist, orthosis, cortisone injection, chiropractor, naprapathy and
other. One response missing in rESWT.
††One response missing in rESWT.

Ultrasound measurements of the plantar fascia was removed as
a secondary outcome from ​ClinicalTrials.​gov in November 2019
due to lack of reliability.
RESULTS
Enrolment and follow-up
Of 320 patients referred to the clinic with heel pain, 200
patients underwent randomisation for inclusion in the study.
Patients were referred by local GPs. A few were referred from
specialised care. Information about the study was available
for the public on the web site of Oslo University Hospital, in
addition GPs received information letters about the study on
three occasions during the inclusion period. 184 (92%) patients
attended the 6-­month follow-­up, and all patients who under-
went randomisation were included in the ITT analysis (figure 1).
The final 6-­month follow-­up was conducted in August 2022
and the final 12-­month follow-­up was completed in January
2023. Baseline demographic and clinical data are displayed in
table 1. Any recorded concomitant treatments are provided in
online supplemental appendix 1. 23 of 174 patients reported
receiving treatments in addition to the allocated interventions
while enrolled in the study at 6 months, between five and seven
in each group. There were no major harms registered as a result
of any of the study’s interventions except for treatment-­related
pain and discomfort in all treatment groups (online supple-
mental appendix 1).
Primary outcome
The results of the primary analysis revealed no statistically signif-
icant between-­group differences in mean change in NRSa from
baseline to 6 months in the rESWT, sham-­rESWT and exercise
groups compared with advice plus customised foot orthoses.
At 6 months, patients in all treatment groups demonstrated
statistically significant improvements in the primary outcome
compared with baseline (table 2). At 6 months the mean change
of NRS exceeded the minimally important change (MIC) of 234
in all groups. Analysis of the mean change in NRSa scores from
baseline to 3-­month, 6-­month and 12-­month follow-­ups showed
no statistically significant between-­group differences (figure 2
and online supplemental appendix 1).
Secondary outcomes
The analysis of the secondary outcomes also showed no statisti-
cally significant between-­group differences in mean change from
baseline to 6 months in the rESWT, sham-­rESWT and exercise
groups compared with advice plus customised foot orthoses.
Mean within-­ group changes in secondary outcome measures

Heide M, et al. Br J Sports Med 2024;0:1–9. doi:10.1136/bjsports-2024-108139 5

 Original research

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Table 2 Intention-­to-­treat analysis of primary and secondary outcomes at 6 months for the four intervention groups (n=50 in each group)
PROM Baseline n 6 months Within-­group changes Between-­group differences
Primary outcome, NRSa
 Sham-r­ ESWT 6.24 (5.62 to 6.86) 41 3.13 (2.45 to 3.81) −3.11 (−3.84 to −2.39) 0.52 (−0.49 to 1.53), p=0.31
 rESWT 6.36 (5.74 to 6.98) 47 3.79 (3.15 to 4.43) −2.57 (−3.26 to −1.88) −0.02 (−1.01 to 0.96), p=0.96
 Exercise 6.34 (5.72 to 6.96) 43 3.64 (2.97 to 4.30) −2.70 (−3.42 to −1.99) −0.11 (−1.11 to 0.89), p=0.83
 A & CO 6.30 (5.68 to 6.92) 45 3.71 (3.05 to 4.36) −2.59 (−3.29 to −1.89)
Secondary outcomes
NRSr
 Sham-r­ ESWT 3.90 (3.25 to 4.55) 41 2.26 (1.55 to 2.96) −1.64 (−2.37 to −0.91) −0.02 (−1.04 to 0.99), p=0.97
 rESWT 3.58 (2.93 to 4.23) 47 2.14 (1.47 to 2.81) −1.44 (−2.13 to −0.75) −0.23 (−1.21 to 0.76), p=0.65
 Exercise 3.42 (2.77 to 4.07) 43 2.44 (1.75 to 3.14) −0.98 (−1.69 to −0.26) 0.69 (−0.31 to 1.69), p=0.18
 A & CO 4.04 (3.39 to 4.69) 45 2.37 (1.69 to 3.06) −1.67 (−2.37 to −0.96)
FFI-­RS sum score
 Sham-r­ ESWT 40.89 (35.42 to 46.35) 40 25.11 (19.21 to 31.00) −15.78 (−21.16 to −10.40) −4.80 (−12.26 to 2.67), p=0.21
 rESWT 50.09 (44.62 to 55.55) 43 29.22 (23.47 to 34.7) −20.87 (−26.09 to −15.64) 0.29 (−7.06 to 7.64), p=0.94
 Exercise 43.78 (38.32 to 49.25) 43 26.33 (20.58 to 32.08) −17.45 (−22.67 to −12.23) 3.12 (−4.23 to 10.48), p=0.40
 A & CO 47.15 (41.64 to 52.65) 44 26.57 (20.83 to 32.30) −20.58 (−25.71 to −15.45)
PCS12
 Sham-r­ ESWT 41.34 (38.50 to 44.18) 38 46.94 (43.82 to 50.06) 5.60 (2.68 to 8.52) 1.48 (−2.51 to 5.46), p=0.47
 rESWT 37.40 (34.57 to 40.23) 44 44.41 (41.45 to 47.36) 7.01 (4.28 to 9.74) 0.07 (−3.80 to 3.84), p=0.97
 Exercise 39.55 (36.71 to 42.38) 42 46.50 (43.49 to 49.51) 6.95 (4.15 to 9.75) −0.12 (−4.02 to 3.78), p=0.95
 A & CO 38.79 (35.96 to 41.62) 44 45.86 (42.91 to 48.82) 7.08 (4.34 to 9.81)
MCS12
 Sham-r­ ESWT 44.24 (41.11 to 47.37) 38 46.79 (43.40 to 50.19) 2.55 (−0.34 to 5.44) 1.91 (−2.05 to 5.87), p=0.34
 rESWT 39.60 (36.49 to 42.71) 44 44.55 (41.32 to 47.78) 4.95 (2.24 to 7.66) −0.49 (−4.32 to 3.35), p=0.80
 Exercise 43.43 (40.32 to 46.54) 42 47.43 (44.16 to 50.71) 4.00 (1.23 to 6.77) −0.46 (−4.34 to 3.41), p=0.67
 A & CO 41.78 (38.67 to 44.90) 44 46.25 (43.01 to 49.48) 4.46 (1.75 to 7.17)
Mean between group differences that is, comparison of treatment with advice plus customised foot orthoses.
Values are mean (95% CI). Patient-­reported outcome measurement (PROM), Number of patients with complete data at 6 months follow-­up (n), Numeric Rating Scale during
activity (NRSa; 0–10, lower scores indicate less pain), Numeric Rating Scale at rest (NRSr), Foot Function Index-­Revised Short Form (FFI-­RS; 0–100, lower scores indicate better
foot health), Physical Component Summary score (PCS12), Mental Component Summary score (MCS12; 0–100, higher scores indicate better health-­related quality of life), radial
extracorporeal shock wave therapy (rESWT), advice plus customised foot orthoses (A & CO).

from baseline to 6-­month follow-­up showed statistically signif-

icant improvement in all intervention groups except for the
MCS12 score derived from the RAND-­12 in the sham-­rESWT
group (table 2). Analysis of the mean changes in secondary
outcomes from baseline to 3, 6 and 12 months showed no statis-
tically significant between-­group differences (figure 3 and online
supplemental appendix 1). On the PGIC scale, 12.5% reported
‘very much improved’, 30.5% ‘much improved’, 31% ‘minimally
improved’, 19.5% ‘unchanged’, 3% ‘minimally worse’ and 3.5%
‘much worse’, with no significant between-­group differences at
6-­month follow-­up. No participants categorised themselves as
‘very much worse’.

Figure 2 Intention-­to-­treat analysis of change in heel pain during
activity in the four treatment groups. Whiskers represent 95% CI.
Numeric Rating Scale during activity in the previous week (pain activity
(NRSa)). Y axis shows scale from 0 to 10; higher scores indicate more
pain. A & Co, advice plus customised foot orthoses; rESWT, radial
extracorporeal shock wave therapy.
Per-protocol analysis
Compliance was high in the rESWT and sham-­rESWT groups.
Two patients in the rESWT group and one patient in the sham-­
rESWT group did not complete the treatment as per protocol. In
the exercise group, slightly lower compliance was observed, with
37 of 50 patients (74%) completing treatment as per protocol.
The results of the per-­protocol analysis did not reveal between-­
group treatment effects (online supplemental appendix 1).
Blinding of rESWT groups
In the rESWT group, 79% (38 of 48) of patients correctly
guessed that they received real rESWT treatment, 8% (4 of 48)

6 Heide M, et al. Br J Sports Med 2024;0:1–9. doi:10.1136/bjsports-2024-108139

 Original research

Br J Sports Med: first published as 10.1136/bjsports-2024-108139 on 20 June 2024. Downloaded from http://bjsm.bmj.com/ on June 27, 2024 by guest. Protected by copyright.
Figure 3 Intention-­to-­treat analysis of change in secondary outcome measures in the four treatment groups. Whiskers represent 95% CI.
(A) Numeric Rating Scale at rest in the previous week (pain rest (NRSr)). Y axis shows scale from 0 to 10; higher scores indicate more pain. (B) Foot
Function Index-­Revised Short Form (FFI-­RS). Y axis shows only scores from 10 to 60; lower scores indicate better foot function. (C) RAND-­12 Health
Status Inventory (RAND-­12) Physical Component Summary score (PCS12). Y axis shows only scores from 30 to 60; higher scores indicate better
physical health. (D) RAND-­12 Mental Component Summary score (MCS12). Y axis shows only scores from 30 to 60; higher scores indicate better
mental health. A & Co, advice plus customised foot orthoses; rESWT, radial extracorporeal shock wave therapy.

guessed sham treatment and 13% (6 of 48) answered ‘I don’t
know’. In the sham-­rESWT group, 61% (30 of 49) guessed that
they had received real rESWT, while 16% (8 of 49) correctly
guessed that they had received sham treatment, and 22% (11 of
49) answered ‘I don’t know’.
DISCUSSION
Principal findings
In this trial evaluating patients with plantar fasciopathy, no addi-
tional benefit of rESWT, sham-­rESWT or a high-­load exercise
programme over advice plus customised foot orthoses alone was
observed in improving pain, foot function and health-­related
quality of life. All treatment groups improved significantly in
all outcomes from baseline to 6 months, except for the Mental
Component Summary score of RAND-­12 in the sham-­group. The
ITT analysis of the mean changes in the primary and secondary
outcomes at 3, 6 and 12 months revealed no significant between-­
group differences.
Ibrahim et al16 and Gerdesmeyer et al15 demonstrated that
rESWT was superior compared with sham-­ rESWT, which
contrasts with the results from the present trial. The previous
studies are comparable methodologically to the present RCT,
but neither assessed a patient evaluation of the blinding. The
uncertainty regarding the success of blinding, may have affected
the results. A recent systematic review and meta-­analysis have
revealed the powerful placebo effects of ESWT in the treat-
ment of plantar fasciopathy35 and may be an explanation of
the improvements in the sham-­rESWT group in the present
study. The present study complement the results of a recent
systematic review including RCTs comparing radial or focused

Heide M, et al. Br J Sports Med 2024;0:1–9. doi:10.1136/bjsports-2024-108139 7

 Original research
ESWT with placebo showing no superior effects of shock wave
therapy.14
In contrast to previous trials21 22 36 the physiotherapist in
the present study conducted multiple sessions with patients in
the high-­load strength training group to provide guidance and
ensure adherence, as the ability to attain sufficient progressive
loading can influence treatment outcomes.37 Most patients in the
exercise group (74%) completed according to the per protocol,
though the physiotherapist made individualised adjustments that
deviated from the planned regimen. Few patients reached 6 RM
at week 9–12. Individualisation is necessary in clinical practice,
and Riel et al36 found no differences in the effectiveness of self-­
dosed and predetermined exercise programmes for patients with
plantar fasciopathy. The plantar fascia is not considered a regular
tendon, as it has no direct in-­line muscular attachment. This may
cause a response to high-­load strength training that differs from
that of other tendons in the lower extremities, which may explain
the lack of benefit of the training programme observed in this
study. It is possible that future trials on other types of progressive
strengthening programmes provide different results.38
The content of the ‘advice plus customised orthoses’ interven-
tion was based on our experience and the latest research and was
developed in late 2017 and close to the ‘usual care’ at our outpa-
tient clinic. It is comparable to the core approach for plantar
heel pain management published in 202112 except for the guide-
line’s recommendations to tape and stretch the plantar fascia.
In addition, unlike the recommendations in the management
guide, all patients in the present study were provided customised
orthoses. The inclusion of orthoses was a topic of debate during
the planning of the trial, as most patients referred to our outpa-
tient clinic have already tried prefabricated foot orthoses, and
some have also tried customised foot orthoses. In order to stan-
dardise this part of the treatment, we provided customised foot
orthoses to all participants. A recent systematic review found
moderate evidence supporting customised orthoses on pain in
the short term.14 Future high-­quality trials may establish the type
and role of orthoses in the treatment of plantar fasciopathy.
Strengths and weaknesses
This RCT included a large sample of patients, unlike the small
samples used in most studies included in previous systematic
reviews.10 11 39 We compared the effectiveness of common treat-
ments with placebo and an intervention including advice plus
customised foot orthoses, which enhanced the study’s relevance
and external validity. The harms associated with the interven-
tions were regarded as minor and only 13% (23 of 172) of
the patients reported additional treatment during the trial at 6
months.
The sample size was based on an assumed mean difference in
pain during activity of 2 on the NRS.34 Varying MIC values for
pain has been reported.23 40 Increasing the sample size in order to
detect smaller between group differences may lead to increased
type I errors.
The study was completed at one hospital and the treatments
was delivered by one highly experienced physiotherapist. In
addition, most patients had long-­term symptoms suggesting a
more severe spectrum of the condition, typically representing a
specialised care setting41 which limits generalisability. Custom-
ised orthoses are not routinely provided for patients with plantar
fasciopathy and limits the applicability of the trial findings in a
primary care setting.
The higher number of patients believing that they received
real rESWT compared with sham-­rESWT could be a result of
8 Heide M, et al. Br J Sports Med 2024;0:1–9. doi:10.1136/bjsports-2024-108139
patients’ previous experience with rESWT or the lack of blinding
Br J Sports Med: first published as 10.1136/bjsports-2024-108139 on 20 June 2024. Downloaded from http://bjsm.bmj.com/ on June 27, 2024 by guest. Protected by copyright.
of the physiotherapist. However, this appeared to not impact the
study’s result.
Comprehensive process evaluation was not performed in the
present study and might have shed more light on the important
components of the treatment arms as well as confounding envi-
ronmental factors.42 Participating in a study conducted in a
specialised care setting with multidisciplinary healthcare involve-
ment or the natural course of the condition may have influenced
the outcome. The present study was not powered for subgroup
analyses, but explorative analyses of predictive factors for the
total sample will be provided in a future manuscript.
CONCLUSIONS
In the present study, there was no additional effect of rESWT,
sham-­rESWT or a standardised exercise programme compared
with advice plus customised foot orthoses alone in alleviating
heel pain in patients with plantar fasciopathy.
Acknowledgements We thank Sophies Minde Ortopedi AS for its financial
support and CPO Peter Strøm, Cecilie Lahn and Anders Dahler for providing the
customised foot orthoses. We also thank all patients who volunteered to participate
in this trial.
Contributors MH, CR, MM, JIB and AFH contributed to designing the study,
analysing and interpreting data, and drafting the manuscript and its final version. CB
contributed to analysing the data and revising the draft and the final manuscript. KM
contributed to interpreting the data and revising the draft and the final manuscript.
All authors agreed to the final version of the manuscript. MH acts as garantor and
takes responsibility for the work, had access to the data and controlled the decision
to publish.
Funding This trial was funded by Sophies Minde Ortopedi AS, a daughter company
of Oslo University Hospital. Sophies Minde Ortopedi AS is a supplier of orthopaedic
aids. Sophies Minde was not involved in the planning, analyses or publishing process.
Competing interests None declared.
Patient and public involvement Patients and/or the public were not involved in
the design of the study, but in the conduct or dissemination plans of this research.
Refer to the method section for further details.
Patient consent for publication Not applicable.
Ethics approval This study involves human participants and this trial was
approved by the Regional Committee for Medical and Health Research Ethics
Southeast Norway (2017/1325). Participants gave informed consent to participate in
the study before taking part.
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement Data are available upon reasonable request.
Supplemental material This content has been supplied by the author(s). It
has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have
been peer-­reviewed. Any opinions or recommendations discussed are solely those
of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and
responsibility arising from any reliance placed on the content. Where the content
includes any translated material, BMJ does not warrant the accuracy and reliability
of the translations (including but not limited to local regulations, clinical guidelines,
terminology, drug names and drug dosages), and is not responsible for any error
and/or omissions arising from translation and adaptation or otherwise.
Open access This is an open access article distributed in accordance with the
Creative Commons Attribution Non Commercial (CC BY-­NC 4.0) license, which
permits others to distribute, remix, adapt, build upon this work non-­commercially,
and license their derivative works on different terms, provided the original work is
properly cited, appropriate credit is given, any changes made indicated, and the use
is non-­commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
ORCID iD
Marte Heide http://orcid.org/0000-0003-0135-5332
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