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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06418360
Other study ID # E2-23-3792
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 13, 2023
Est. completion date November 23, 2023

Study information

Verified date May 2024
Source Ankara City Hospital Bilkent
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Objective: The aim of the present study was to investigate the treatment efficacy of TECAR therapy, a modern application that has been increasingly used in recent years, compared to conventional physical therapy applications in the treatment of knee osteoarthritis, according to the evaluation of the clinical findings of patients. Methods: A total of 54 patients, aged between 40 and 75 years, were randomly divided into two groups. Both groups received CPT. Group 2 received TECAR therapy in addition to CPT, applied three times a week for two weeks, for a total of 6 sessions. All patient's knee joint range of motion (ROM) was measured goniometrically, isometric quadriceps muscle strength was measured, and pain levels were assessed using the Visual Analog Scale (VAS), and disability levels were assessed using the Western Ontario and McMaster Universities Arthritis Index (WOMAC) before treatment, at the end of treatment, at 1 month, and at 3 months.


Recruitment information / eligibility

Status Completed
Enrollment 54
Est. completion date November 23, 2023
Est. primary completion date August 23, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - 3 months of conservative treatment for unresponsive knee pain - Kellgren-Lawrence grade 2-3 on radiographic evaluation - Agreed to participate in the study. Exclusion Criteria: - History of physical therapy (electrotherapy/exercise) in the past 3 months - Intra-articular injection therapy in the past 3 months, - History of surgery or trauma to the affected knee - Inflammatory or neurological disease affecting the lower extremities - Active vasculitis or severe peripheral vascular disease - Pregnancy or lactation - Diagnosed restless legs syndrome - Neoplasia - Local sensory impairment, - Local or systemic acute infections - Severe osteoporosis - Pacemaker - Psychiatric disorder and cognitive impairment.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
TECAR
Transfer Energy Capacitative and Resistive Therapy
conventional physical therapy; Transcutaneous Electrical Nerve Stimulation, hotpack
10 sessions of HP and TENS for two weeks, five times a week. HP was applied to the painful knee area for 20 minutes using a heating pad for superficial heating purposes. TENS was applied to the painful knee area for 20 minutes at 80 Hz frequency

Locations

Country Name City State
Turkey Özge TEZEN Ankara

Sponsors (1)

Lead Sponsor Collaborator
Ankara City Hospital Bilkent

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Visual Analog Scale (VAS) 0 min , 10 is maximum pain score Before and the after treatment 0th day , 1th month, 3rd month
Primary Western Ontario and McMaster Universities Arthritis Index (WOMAC) This 24-item index comprises three subscales: pain, stiffness, and physical function, each measured on a five-point Likert scale ranging from "none" to "extreme." Before and the after treatment 0th day, 1th month, 3rd month
Primary Range of Motion (ROM) Flexion and extension of the knee joint were measured using a universal goniometer relative to reference points. Before and the after treatment 0th day, 1th month, 3rd month
Secondary The Diers Myoline Isometric Muscle Strength Measurement System quadriceps muscle Isometric Strength Measure: Increased isometric muscle strength is an indicator of recovery. Before and the end of treatment 0th day, 1th month, 3rd month
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