Home-Based Strategies for Knee Osteoarthritis

NCT ID: NCT07212647

Last Updated: 2025-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-09

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Knee Osteoarthritis Knee Osteoarthritis (Knee OA)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized Controlled Trial
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors
single

Study Groups

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Home Exercise Group

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

Group Type EXPERIMENTAL

Home Exercise Group

Intervention Type 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

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

Group Type ACTIVE_COMPARATOR

Topical Therapy Group

Intervention Type 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

Interventions

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Home Exercise Group

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

Intervention Type OTHER

Topical Therapy Group

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istanbul University - Cerrahpasa

OTHER

Sponsor Role lead

Responsible Party

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Sezen Karaborklu Argut

Dr., assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Istanbul University-Cerrahpaşa Faculty of Health Science

Istanbul, Buyukcekmece, Turkey (Türkiye)

Site Status RECRUITING

Sezen Karaborklu Argut

Istanbul, , Turkey (Türkiye)

Site Status ENROLLING_BY_INVITATION

Countries

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Turkey (Türkiye)

Central Contacts

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Sezen Karaborklu Argut, Dr, Associate professor

Role: CONTACT

+90 212 866 37 00

Facility Contacts

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Sezen Karaborklu Argut, PhD

Role: primary

+902128663700

Other Identifiers

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132409382161

Identifier Type: -

Identifier Source: org_study_id

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