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Completed

NCT Number: NCT07212647

Home-Based Strategies for Knee Osteoarthritis

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.

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Knee Osteoarthritis (Knee OA) Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul University-Cerrahpaşa Faculty of Health Science, Istanbul, Buyukcekmece, Turkey (Türkiye)

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults aged 40-70 years
  • Diagnosed with Kellgren-Lawrence grade I-II knee osteoarthritis
  • Ability to provide written informed consent

Exclusion criteria

  • Advanced KOA (Kellgren-Lawrence grade IV) requiring arthroplasty
  • Prior knee surgery within the past year
  • Intra-articular injections within the last 3 months
  • Neurological, rheumatological, or systemic conditions affecting mobility
  • Inability to comply with study procedures

Treatment and study plan

Home Exercise Group

Other

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

Topical Therapy Group

Other

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

Primary outcomes

  1. Numeric Pain Rating Scale (NPRS)

    Time frame: Baseline

    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.

  2. Numeric Pain Rating Scale (NPRS)

    Time frame: Six-week

    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.

Secondary outcomes

  1. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

    Time frame: Baseline

    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.

  2. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

    Time frame: Six-week

    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.

  3. 12-Item Short Form Survey (SF-12)

    Time frame: Baseline

    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

  4. 12-Item Short Form Survey (SF-12)

    Time frame: Six- week

    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

Sponsors and collaborators

Lead sponsor

Istanbul University - Cerrahpasa

Other

Registry information

Official study title

Home-Based Strategies for Knee Osteoarthritis: Comparative Effectiveness of Exercise and Topical Therapy in a Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 8, 2025
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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