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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.


Recruitment information / eligibility

Status Completed
Enrollment 90
Est. completion date December 4, 2023
Est. primary completion date October 9, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Adult cases aged 18-65 years diagnosed with plantar fasciitis by a physical medicine and rehabilitation specialist, - Cases willing to continue the study, - In the anamnesis, cases with severe pain when taking the first step after waking up in the morning or after a long period of inactivity and progressive aggravation of the pain as the activity continues, - Cases whose consent forms were obtained by being informed about the study. Exclusion Criteria: - Cases who have undergone foot and ankle surgery, - Loss or decrease of sensation in the foot and ankle region for various reasons, - Difficulty in communication that prevents treatment and evaluations from being carried out effectively, - Pregnancy, - Presence of local infection, - Having a widespread or regional tumoral disease, - Having circulatory disorders in the lower extremities, bleeding, - Anticoagulant use, - Application of other treatment methods such as cold/hot application, exercise, orthosis use, electrotherapy agents, - Cases with a history of systemic, inflammatory, neurological or vascular disease.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Turkey Necmettin Erbakan Üniversitesi Konya

Sponsors (1)

Lead Sponsor Collaborator
Necmettin Erbakan University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Other Plantar Fascia Elasticity Measurement The person will be asked to pull his/her fingers back without bending his/her knees and keeping the heel and metatarsal heads in contact with the wall, and the distance between the thumb and the wall will be measured in cm. baseline, post treatment (at 1th week)
Primary Visual Analogue Scale (VAS) ). VAS, with numbers from 0 to 10 on a 10 cm horizontal line; 0 means "no pain"; It was stated to the patients that 10 represented "unbearable pain". The degree of pain was recorded numerically between 0 and 10 baseline, post treatment (at 1th week)
Secondary Lower Extremity Functional Scale Lower Extremity Functional Scale; It is a scale developed to evaluate individuals' lower extremity functions, skills and activity limitations, translated into Turkish, and its validity and reliability have been established. Scoring is made between 0-80, with higher values indicating better functional level. baseline, post treatment (at 1th week)
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