Comparison of 3 devices on clinical outcomes in plantar fasciitis
accordance with the World Medical Association
Declaration of Helsinki (23), according to good
clinical practice, and registered with ClinicalTri-
als.gov (identifier NCT02608723).
203
Total number of possible participants
(n=234)
Excluded (n=99)
Did not meet eligibility criteria (n=80)
Did not agree to participate in the study (n=19)!
Intervention
All patients followed the same schedule of visits
Randomized (n=135)
in an identical setting. During the first visit, pa-
tients were given an information document about
the study, and the lead researcher explained the
study aims with the wording: “the 3 devices are
Assigned to the
Assigned to the
effective, all 3 are good, but we want to know
standard device group
sophisticated device group
which of them is best”. Information on plantar
(n=45)
(n=45)
fascia and gastrocnemius muscle stretching
exercises was also provided and explained. The
All patients
All patients
patients then underwent a baseline evaluation:
completed the
completed the
they were asked to complete the Foot Function
study protocol
study protocol
Index (FFI) questionnaire, a visual analogue
scale (VAS) was used to assess pain, and a foot
ultrasound was performed. Each patient was then
Lost to follow-up in the
Lost to follow-up in the
taken to another room containing all 3 devices,
standard device group
sophisticated device group
where they were to be treated. The area of the tre-
(n=3)
(n=0)
atment room was 10 m 2 , it contained a stretcher,
2 chairs and the 3 devices, located next to each
other (Figs 2 and 3). A second researcher explai-
ned the treatment procedure for 1 min and how
the 3 rESW devices worked. He fired 32 shock
Analysed in the standard
Analysed in the
waves (4 s) into the air using each device, so that
device group during
sophisticated device group
the patient could hear and see the operation of
(n=42)
(n=45)
the devices. The envelope assigning the device
Fig. 1. Flowchart of participants.
to that individual was then opened. The patient
looked at the assigned device for 1 min, and was
then asked to remove their shoes and lie on the
stretcher in a prone position for the first session. All patients
received 3 sessions, 1 per week. Patient interaction with the de-
vices in the second and third session was the same as in the first
session: the researcher explained the operation of the 3 devices
for 1 min, then the patient observed the assigned device for 1
min. In each session 2,500 radial extracorporeal shock waves
were applied at a frequency of 8 Hz. The applied energy was
adjusted to the maximum discomfort the patient could tolerate,
resulting in an individual air pressure of between 2.0 and 4.0
bar and, thus, a positive energy flux density of between 0.10
and 0.18 mJ/mm2. No local anaesthesia or analgesic drugs were
given during the sessions. The patients were followed-up at 1,
2, 4 and 14 months after the last radial extracorporeal shock
wave therapy (rESWT) session.
Assigned to the austere
device group (n=45)
All patients
completed the
study protocol
Lost to follow-up in
austere device group
(n=4)
Analysed in the austere
device group
(n=41)
Fig. 2. The devices used in the present study: (1) sophisticated device;
(2) austere device; (3) standard device.
Fig. 3. Close-up of the devices: (1) sophisticated device; (2) austere device; (3) standard device.
J Rehabil Med 51, 2019