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.
• 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