Daily knee sleeve use in older adults with chronic knee pain

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this superiority randomized trial, 235 adults aged 50–64 with chronic knee pain are assigned to either daily use of an elasticized knee sleeve or no knee sleeve. Knee radiographs will be taken at baseline and year 5, and participants will complete KOOS surveys at baseline, 3 months, and annually to track pain, function, and quality of life. An interim analysis of the 1-year KOOS data is planned. The study aims to determine if a simple, low-cost intervention can influence long-term structural and symptom outcomes in knee osteoarthritis.

Why it matters

Who can join: the full rules

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

Where it's running

• RAYUS Radiology
  Springfield, Massachusetts, United States Recruiting

Study contacts

• Principal investigator: Margaret L Gourlay, MD, MPH — Knee Sleeve Trial Collaborative, LLC
• Study coordinator: Margaret L Gourlay, MD, MPH
• Email: info@kneesleevetrial.org
• Phone: 413-213-4655

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.