Clinical Trial

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

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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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-06-26.
Trial Details
NCT Number NCT07674901
Lead Sponsor Margaret L Gourlay, MD, MPH
Collaborators: Knee Sleeve Trial Collaborative, LLC
Conditions Knee Arthritis, Osteoarthritis
Enrollment 235 participants
Start Date 2026-09
Primary Completion 2032-09 (estimated)
Study Completion 2032-09 (estimated)
Updated on ClinicalTrials.gov 2026-07-01