RecruitingNot ApplicableNCT07674901

Daily Knee Sleeve Use Versus No Use in Older Adults With Chronic Knee Pain

A Superiority Randomized Controlled Trial of Daily Knee Sleeve Use Versus No Use in Older Adults With Chronic Knee Pain


Sponsor

Margaret L Gourlay, MD, MPH

Enrollment

235 participants

Start Date

Sep 1, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this superiority randomized controlled trial is to evaluate the effect of daily knee sleeve use on 5-year radiographic knee osteoarthritis progression and knee-related symptoms in older adults with chronic knee pain. The investigators will recruit 235 individuals aged 50-64 years at baseline with chronic (≥ 3 months) knee pain, randomized to daily use of an elasticized fabric knee sleeve versus no knee sleeve use. Participants will have knee radiographs at baseline and year 5 and will complete a survey including Knee injury and Osteoarthritis Outcome Score (KOOS) subscales for pain, knee function and quality of life at 3 months and annually. A prespecified interim analysis of the 1-year KOOS subscore data will be performed.


Eligibility

Min Age: 50 YearsMax Age: 64 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Knee sleeve for people with knee arthritis, osteoarthritis. The study is currently recruiting participants at 1 location. People eligible for this study include aged 50 Years to 64 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEKnee sleeve

Daily use of one of the following: * Mueller 4-way Stretch Knee Support * Mueller FIR Knee Support * PhysFlex Knee Brace


Locations(1)

RAYUS Radiology

Springfield, Massachusetts, United States

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NCT07674901


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