Home-Based Strategies for Knee Osteoarthritis

NCT07212647 | Completed

• 1 other identifier: 132409382161
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Knee Osteoarthritis; Knee Osteoarthritis (Knee OA)

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Six-week

Secondary Outcomes (4)

• Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

  Baseline

• Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

  Six-week

• 12-Item Short Form Survey (SF-12)

  Baseline

• 12-Item Short Form Survey (SF-12)

  Six- week

Study Arms (2)

Home Exercise Group

EXPERIMENTAL

Each subject in the home exercise group will receive a video-based protocol of exercises for knee osteoarthritis to perform at home.

Other: Home Exercise Group

Topical Therapy Group

ACTIVE COMPARATOR

Each subject in the topical therapy group will apply topical gel to anterior, medial, and lateral aspects of the knee at home.

Other: Topical Therapy Group

Interventions

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

Home Exercise Group

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

Topical Therapy Group

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (2)

Istanbul University-Cerrahpaşa Faculty of Health Science

Istanbul, Buyukcekmece, 34500, Turkey (Türkiye)

Location

Sezen Karaborklu Argut

Istanbul, 34295, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Psychotherapy, Group

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Socioenvironmental Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: single
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr., assistant professor

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: October 1, 2025
• First Posted: October 8, 2025
• Study Start: October 9, 2025
• Primary Completion: February 26, 2026
• Study Completion: February 26, 2026
• Last Updated: February 27, 2026

Record last verified: 2025-10

Locations

TU (2)