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

June 26, 2026 updated by: Margaret L Gourlay, MD, MPH

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

235

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Massachusetts
      • Springfield, Massachusetts, United States, 01107
        • RAYUS Radiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Aged 50-64 years at the time of his/her baseline eligibility screening
  2. Unilateral or bilateral chronic (≥ 3 months) knee pain
  3. Knee circumference between 12" (30 cm) and 22" (56 cm) measured over center of kneecap; or if a larger size is needed, thigh circumference up to 28" (71 cm) measured at 4" ABOVE center of knee cap per manufacturers' size specifications for the knee sleeves used in the intervention
  4. English-speaking and able to provide informed consent for study participation

Exclusion Criteria:

  1. History of knee replacement surgery in the painful/affected knee(s)
  2. Knee replacement surgery or arthroscopic procedure scheduled or anticipated in the affected knee(s) within 1 year after study eligibility screening
  3. Self-reported history or medical documentation of rheumatoid arthritis, psoriatic arthritis or other inflammatory arthritis in any joint; peripheral arterial disease or other vascular or circulatory disorder; blood clotting disorder; bleeding disorder or self-reported easy bruising; current treatment with an anticoagulant or antiplatelet agent; immobility; nonambulatory status; knee ligament tear or rupture; or lower extremity fracture requiring internal or external fixation within 1 year before study eligibility screening
  4. History of unprovoked falls
  5. Current use of a rigid or hinged knee brace made of metal, plastic or fiberglass, or prescription for a knee brace for the affected knee(s)
  6. Previous use of a knee sleeve/fabric knee support on the affected knee(s) for over 6 months cumulative time
  7. Inability to pull on or remove elasticized knee sleeve from affected knee(s)
  8. Kellgren-Lawrence (KL) grade 4 on a baseline standing/weightbearing A/P knee radiograph of the affected knee(s) is excluded because it is the highest KL grade, so a primary outcome event (transition to a higher grade) is impossible.
  9. Moderate to severe knee effusion on baseline radiographs of the painful knee(s) is excluded due to the potential risk of harm and discomfort from the compressive effect of a knee sleeve. Individuals with moderate to severe knee effusion during the first screening assessment who are otherwise eligible will be invited to have a repeat A/P knee x-ray 2 months later to reassess radiological eligibility. If the effusion is mild or has resolved by that time, the individual will be invited to enroll in the study.
  10. Pregnancy (because of x-ray exposure)
  11. Cannot attend a 5-year study assessment for follow-up knee radiographs
  12. Investigator discretion

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Knee sleeve
Daily knee sleeve use
Device: Knee sleeve

Daily use of one of the following:

  • Mueller 4-way Stretch Knee Support
  • Mueller FIR Knee Support
  • PhysFlex Knee Brace
No Intervention: Control
No knee sleeve use

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in radiographic grade of knee osteoarthritis severity
Time Frame: Change from baseline at 5 years
Kellgren-Lawrence radiographic grade 0 (best) to 4 (worst) on standing/weightbearing anterior/posterior (A/P) knee radiograph
Change from baseline at 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in knee pain
Time Frame: Change from baseline at 1 year (also assessed at 3 months and annually years 2-5)

Knee injury and Osteoarthritis Outcome Score (KOOS) pain subscore

The KOOS pain subscale includes 9 questions with 5 answer options each, scored from 0 (no knee problems) to 4 (extreme knee problems). The sum of the items is transformed to a 0-100 scale, with 0 representing extreme knee problems and 100 representing no knee problems.
Change from baseline at 1 year (also assessed at 3 months and annually years 2-5)
Change in knee function
Time Frame: Change from baseline at 1 year (also assessed at 3 months and annually years 2-5)

KOOS activities of daily living subscore

The KOOS activities of daily living function subscale includes 17 questions with 5 answer options each, scored from 0 (no knee problems) to 4 (extreme knee problems). The sum of the items is transformed to a 0-100 scale, with 0 representing extreme knee problems and 100 representing no knee problems.
Change from baseline at 1 year (also assessed at 3 months and annually years 2-5)
Change in knee-related quality of life
Time Frame: Change from baseline at 1 year (also assessed at 3 months and annually years 2-5)

KOOS quality of life subscore

The KOOS quality-of-life subscale includes 4 questions with 5 answer options each, scored from 0 (no knee problems) to 4 (extreme knee problems). The sum of the items is transformed to a 0-100 scale, with 0 representing extreme knee problems and 100 representing no knee problems.
Change from baseline at 1 year (also assessed at 3 months and annually years 2-5)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of participants with incident arthroscopic knee procedure or knee replacement surgery
Time Frame: Change from baseline at 5 years
Participant report or medical documentation of arthroscopic knee procedure or knee replacement surgery
Change from baseline at 5 years
Proportion of participants with patellar instability
Time Frame: Change from baseline at 5 years
Radiographic signs of patellar instability including: 1) patellar tilting, 2) lateral patellar subluxation, 3) interval patellofemoral joint space narrowing by year 5, 4) Insall-Salvati ratio >1.2 (Patella alta)
Change from baseline at 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Margaret L Gourlay, MD, MPH

Collaborators

Knee Sleeve Trial Collaborative, LLC

Investigators

  • Principal Investigator: Margaret L Gourlay, MD, MPH, Knee Sleeve Trial Collaborative, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

September 1, 2032

Study Completion (Estimated)

September 1, 2032

Study Registration Dates

First Submitted

June 22, 2026

First Submitted That Met QC Criteria

June 26, 2026

First Posted (Actual)

June 30, 2026

Study Record Updates

Last Update Posted (Actual)

June 30, 2026

Last Update Submitted That Met QC Criteria

June 26, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WCG IRB Study Number 1404409

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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