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

Part of paid clinical trials in Springfield, Massachusetts.

Sponsor
Margaret L Gourlay, MD, MPH
Study ID
NCT07674901
Status
Recruiting
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Conditions

  • Knee Arthritis, Osteoarthritis

Eligibility Criteria

Sex
ALL
Age
50 Years - 64 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Jun 30, 2026
Start date
Sep 30, 2026
Status verified
Sep 2026
Primary completion
Sep 30, 2032
Completion
Sep 30, 2032

Study Design

Enrollment
235 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Knee sleeve
    Daily knee sleeve use
  • No Intervention: Control
    No knee sleeve use

Primary Outcome Measure

Change in radiographic grade of knee osteoarthritis severity [ Time Frame: Change from baseline at 5 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
RAYUS RadiologySpringfieldMassachusetts01107
Margaret L Gourlay, MD, MPH
[email protected]
413-213-4655
Margaret L Gourlay, MD, MPH (PRINCIPAL_INVESTIGATOR)
Victor S Ritter, PhD, Stanford University (SUB_INVESTIGATOR)
Anthony R Jeanmenne, MD, RAYUS Radiology (SUB_INVESTIGATOR)
David F Ransohoff, MD, UNC Chapel Hill (SUB_INVESTIGATOR)
Jeffrey T Spang, MD, Wake Forest University (SUB_INVESTIGATOR)

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By research site
RAYUS Radiology· Springfield, MA

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