Daily Knee Sleeve Use Versus No Use in Older Adults With Chronic Knee Pain
Key facts
- Who runs it
- Margaret L Gourlay, MD, MPH
- Where
- Springfield, United StatesSee the site
- Trial code
- Status
- Recruiting
- People taking part
- 235 people, planned
- Started
- 21 Oct 2026
- Expected to end
- Sept 2032
- Type of study
- Interventional, 2 groupsOne group gets no study treatment, for comparison.
- Treatments tested
- Knee sleeve
- Record updated
- 27 October 2026
Who can take part
- Age
- 50 years to 64 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 16 criteriaShow less
Who can take part
- Aged 50-64 years at the time of his/her baseline eligibility screening
- Unilateral or bilateral chronic (≥ 3 months) knee pain
- 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
- English-speaking and able to provide informed consent for study participation
Who cannot take part
- Knee replacement surgery or arthroscopic procedure scheduled or anticipated in the affected knee(s) within 1 year after study eligibility screening
- 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
- Previous use of a knee sleeve/fabric knee support on the affected knee(s) for over 6 months cumulative time
- History of knee replacement surgery in the painful/affected knee(s)
- History of unprovoked falls
- 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)
- Inability to pull on or remove elasticized knee sleeve from affected knee(s)
- 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
- 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
- Pregnancy (because of x-ray exposure)
- Cannot attend a 5-year study assessment for follow-up knee radiographs
- Investigator discretion
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 50 and 64 years old?
Where in United States
- RAYUS RadiologySpringfield, United StatesContact: Margaret L Gourlay, MD, MPHTaking people
About the trial
What the trial wants to find out
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 baseline, 3 months and annually. A prespecified interim analysis of the 1-year KOOS subscore data will be performed.
The 2 groups in the trial
- Knee sleeveTreatment being tested
Daily knee sleeve use
- ControlNo study treatment, for comparison
No knee sleeve use
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Superiority Randomized Controlled Trial of Daily Knee Sleeve Use Versus No Use in Older Adults With Chronic Knee Pain
- Fit questions
- Built from NCT07674901, who can take part
- Record updated
- 27 October 2026