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

NCT07674901 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 235

Last updated 2026-07-01

No results posted yet for this study

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.

Conditions

  • Knee Arthritis, Osteoarthritis

Interventions

DEVICE

Knee sleeve

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

Sponsors & Collaborators

  • Knee Sleeve Trial Collaborative, LLC

    collaborator OTHER

  • Margaret L Gourlay, MD, MPH

    lead OTHER

Principal Investigators

  • Margaret L Gourlay, MD, MPH · Knee Sleeve Trial Collaborative, LLC

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2032-09-30
Completion
2032-09-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07674901 on ClinicalTrials.gov