Journal of Rehabilitation Medicine 51-3 | Page 55
J Rehabil Med 2019; 51: 201–208
ORIGINAL REPORT
RADIAL EXTRACORPOREAL SHOCK WAVE DEVICE APPEARANCE DOES NOT
INFLUENCE CLINICAL OUTCOMES: A RANDOMIZED CONTROLLED TRIAL
Antoni MORRAL, PT, PhD 1 , Gerard URRÚTIA, MD, PhD 2 , Ignasi GICH, MD, PhD 2 , Reme RUIZ, PT 3 and Xavier
BONFILL, MD, PhD 2
From the 1 Blanquerna School of Health Sciences, Ramon Llull University, 2 Iberoamerican Cochrane Centre, Institut d’Investigació
Biomèdica Sant Pau (IIB Sant Pau), CIBERESP, Universitat Autònoma de Barcelona (UAB), Barcelona and 3 Salut i Esport Rehabilitation
Center, Santa Perpètua de Mogoda, Spain.
Objective: To determine whether the appearance of
a radial extracorporeal shock wave device affects
clinical outcomes in chronic plantar fasciitis.
Study design: Randomized controlled parallel asses
sor-blinded clinical trial.
Material and methods: A total of 135 patients were
assigned to 3 groups: group I, standard radial ex
tracorporeal shock wave device; group II, standard
radial extracorporeal shock wave device modified
to give a more sophisticated appearance; group III,
standard radial extracorporeal shock wave device
modified to give a more austere appearance. The
radial extracorporeal shock waves emitted by the 3
devices were identical. Primary outcome was foot
function, measured with the Foot Function Index.
Secondary outcomes were pain at different times,
measured with a visual analogue scale, and plantar
fascia thickness, measured with ultrasound.
Results: All variables decreased significantly from
baseline assessment, in all 3 groups and at all time-
points: 1, 2, 4 and 14 months after the last session
(p < 0.001). There were no significant differences
between groups for any of the variables assessed.
Conclusion: Device appearance had no statistically
significant influence on clinical outcomes in patients
with chronic plantar fasciitis treated with radial ex
tracorporeal shock wave therapy.
Key words: placebo effect; nocebo effect; plantar fasciitis;
shock wave, therapeutic context.
Accepted Dec 18, 2018; Epub ahead of print Jan 22, 2019
J Rehabil Med 2019; 51: 201–208
Correspondence address: Antoni Morral, Blanquerna School of Health
Sciences, Ramon Llull University, 08025 Barcelona, Spain. E-mail: an-
[email protected]
P
lantar fasciitis is the most common cause of inferior
heel pain. Typical symptoms include pain with the
first weight-bearing step in the morning. Diagnosis of
plantar fasciitis can be made clinically (1). The inci-
dence and prevalence of the condition are not fully
known; however, it is estimated that, in the general
population, 1 in 10 people will experience plantar
fasciitis at least once in their life (2).
Although the suffix “-itis” implies an inflammatory
condition, mounting evidence indicates that this foot
disorder is associated with degenerative changes and
LAY ABSTRACT
The context and environment in which treatment is ad-
ministered is highly relevant. Context variables are per-
ceived and interpreted by patients and can generate po-
sitive or negative expectations. Such expectations may
influence the therapeutic outcome. This study assessed
whether a contextual element, such as the external ap-
pearance of a shock wave device, influenced clinical out-
comes in patients with chronic plantar fasciitis. Three
shock wave devices were compared: a standard device;
a sophisticated device; and an austere device. The only
difference between the devices was their external ap-
pearance. The shockwaves emitted by the 3 devices
were identical. No differences were found between the
3 devices for any of the variables assessed. Health pro-
fessionals and future research into the therapeutic en-
counter context should focus more on patient–therapist
interactions than on the appearance of devices.
should be appropriately classified as a “fasciosis” or
“fasciopathy” (3).
The causes of plantar fasciitis are multifactorial. It
responds well to multiple conservative therapies. The
prognosis is favourable, with resolution of symptoms
in approximately 80% of cases (4). However, there is
no evidence-based consensus on the most effective
treatment. Systematic reviews have shown radial
extracorporeal shock waves (rESW) to be effective
and safe for the treatment of chronic plantar fasciitis
(5–7). The biological effects of rESW are tissue rege-
neration, angiogenesis and analgesia (8, 9), produced
by a mechanotransduction mechanism by which cells
recognize and respond to mechanical stimulation (10).
There are many variables, including the placebo
effect, which can explain the clinical improvement
experienced by patients when they receive a phar-
macological treatment or physical treatment, such
as rESW (11). The placebo and nocebo responses
refer to changes in patients’ symptoms attributable
to their participation in a therapeutic encounter and
its rituals, symbols and interactions (12). However,
other elements, such as patient–therapist relationship,
psychosocial factors, and patients’ hopes, beliefs and
fears, must also be considered (13, 14).
The context and environment in which treatment is
administered is highly relevant. Context variables are
This is an open access article under the CC BY-NC license. www.medicaljournals.se/jrm
Journal Compilation © 2019 Foundation of Rehabilitation Information. ISSN 1650-1977
doi: 10.2340/16501977-2516