Daily Knee Sleeve Use Versus No Use in Older Adults With Chronic Knee Pain
NCT ID
NCT07674901
Registry status
Recruiting
Study type
Interventional
Phase
Not applicable
Sponsor
Margaret L Gourlay, MD, MPH
Conditions
Knee Arthritis, Osteoarthritis
Overview
ClinicalTrials.gov lists this study as Recruiting.
Official title: A Superiority Randomized Controlled Trial of Daily Knee Sleeve Use Versus No Use in Older Adults With Chronic Knee Pain
Enrollment: 235 participants (Estimated).
What is being studied
Device: Knee sleeve
Who may be eligible
Ages
50 Years to 64 Years
Sex
All
Healthy volunteers accepted
No
ClinicalTrials.gov lists the following eligibility criteria.
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 locations
1 study location is listed.
Recruiting site status is explicitly provided for 1 location; 1 is listed as Recruiting.
Countries: United States
Massachusetts, United States: 1
Sample of listed locations
RAYUS Radiology — Springfield, Massachusetts, 01107, United States — Recruiting
Trial information can change. Confirm current study details with the study team or the registry.
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