Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT06055933 |
Other study ID # |
ADagbasi001 |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
Start date |
October 2, 2023 |
Est. completion date |
December 4, 2023 |
Study information
Verified date |
December 2023 |
Source |
Necmettin Erbakan University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
Type of this study: Prospective randomized controlled study. Purpose: The aim of this study
is to compare the acute effect of pain level, lower extremity functionality level and plantar
fascia flexibility in patients with plantar fasciitis receiving Exportacorporeal Shock
Therapy (ESWT).
To compare the acute effect of pain level, lower extremity functionality level and plantar
fascia flexibility in patients with plantar fasciitis who received KT application in addition
to ESWT treatment.
To compare the acute effect of pain level, lower extremity functionality level and plantar
fascia flexibility in patients with plantar fasciitis receiving placebo application.
90 volunteers will be included in the study as ESWT (n=30), placebo ESWT (n=30), ESWT and KT
(n=30) application groups. How effective is ESWT, ESWT and Kinesiotape versus placebo ESWT
acutely in the treatment of plantar fasciitis?
Description:
Plantar fasciitis is a common disease in athletes and the sedentary population, accompanied
by pain and limitation of foot function. Hot-cold tampon application, nonsteroidal
anti-inflammatory drug, heel cushion, night splint, plantar fascia and Achilles stretching
exercise, kinesio taping (CT), ultrasound, and extracorporeal shock wave therapy are the
methods used in the treatment of plantar fasciitis. The aim of this study is to compare the
acute effect on pain level, lower extremity functionality and plantar fascia flexibility in
patients with plantar fasciitis receiving ESWT, patients with plantar fasciitis receiving
Kinesiotape in addition to ESWT, and patients with plantar fasciitis receiving placebo ESWT.
Age (years), height (cm) and body weight (kg) measured with an adult scale with a mechanical
height measure, gender, occupation, affected side and dominant side of patients diagnosed
with plantar fasciitis will be recorded.
Patients will be divided into three groups: ESWT (Group 1), ESWT and KT (Group 2), and
Placebo/Sham (Group 3) application groups. ESWT (BTL-6000SWT, UK); A single session will be
applied at 10 Hz frequency, 2.5 Barr energy and 2000 shocks/session.
For KT application, a tape consisting of 96% cotton, 4% lycra, water-resistant, porous and
adhesive, 5 cm wide and 0.5 mm thick will be used. Taping will be done after the ESWT session
and the tape will be asked to remain for a week. After the first examination of the physical
therapy and rehabilitation specialist physician in the placebo/Sham group, the patient will
be listened to the sound of the device through the audio device and ESWT application will be
applied without the device working.
For clinical follow-up of the patients, visual pain scale (VAS) score, lower extremity
functional scale score will be used before and one week after treatment, and plantar fascia
flexibility will be evaluated.