Knee osteoarthritis (KOA) is a common chronic joint condition leading to pain, functional limitations, and reduced quality of life. This randomized controlled trial aims to evaluate and compare the effectiveness of a structured home-based exercise program versus topical diclofenac sodium therapy in improving pain, functional outcomes, and health-related quality of life among adults with early-stage KOA. The results are intended to provide evidence on the optimal components of home-based conservative management strategies.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
83
Patient education + structured, video-based home exercise program Participants instructed to perform exercises 5 days per week for 6 weeks Adherence monitored via logs and telephone follow-up at week 3
Patient education + 1.5% diclofenac sodium gel Participants applied gel to anterior, medial, and lateral aspects of the knee, once daily, without massage techniques, for 6 weeks
Istanbul University-Cerrahpaşa Faculty of Health Science
Istanbul, Buyukcekmece, Turkey (Türkiye)
Sezen Karaborklu Argut
Istanbul, Turkey (Türkiye)
Numeric Pain Rating Scale (NPRS)
Pain intensity will be measured using an 11-point numeric pain rating scale, with 0 indicating no pain and 10 indicating the worst pain conceivable. Patients will be asked to rate their knee pain's severity with a number between 0 and 10 using this scale. The minimum clinically important difference (MCID) of this validated pain scale is accepted as \>2.
Time frame: Baseline
Numeric Pain Rating Scale (NPRS)
Pain intensity will be measured using an 11-point numeric pain rating scale, with 0 indicating no pain and 10 indicating the worst pain conceivable. Patients will be asked to rate their knee pain's severity with a number between 0 and 10 using this scale. The minimum clinically important difference (MCID) of this validated pain scale is accepted as \>2.
Time frame: Six-week
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
The assessment of functional difficulty will be measured the WOMAC index. The total score of the WOMAC ranges from 0 to 100 (lower scores representing lower level of disability), and the MCID was reported as 12 points.
Time frame: Baseline
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
The assessment of functional difficulty will be measured the WOMAC index. The total score of the WOMAC ranges from 0 to 100 (lower scores representing lower level of disability), and the MCID was reported as 12 points.
Time frame: Six-week
12-Item Short Form Survey (SF-12)
The assessment of health-related quality of life will be measured the 12-Item Short Form Survey (SF-12). The SF-12 physical and mental scores (range 0 to 100, representing worst to best; MCID of 5) was used to evaluate health-related quality of life
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Time frame: Baseline
12-Item Short Form Survey (SF-12)
The assessment of health-related quality of life will be measured the 12-Item Short Form Survey (SF-12). The SF-12 physical and mental scores (range 0 to 100, representing worst to best; MCID of 5) was used to evaluate health-related quality of life
Time frame: Six- week