Daily Knee Sleeve Use Versus No Use in Older Adults With Chronic Knee Pain
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Knee sleeve.
- Who it may be relevant to
- Registry conditions: Knee Arthritis, Osteoarthritis. Basic parameters: 50 years — 64 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Superiority Randomized Controlled Trial of Daily Knee Sleeve Use Versus No Use in Older Adults With Chronic Knee Pain
Overview
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.
Interventions
- Device Knee sleeve
Daily use of one of the following: * Mueller 4-way Stretch Knee Support * Mueller FIR Knee Support * PhysFlex Knee Brace
Primary outcome measures
- Change in radiographic grade of knee osteoarthritis severity [Time frame: Change from baseline at 5 years]
Secondary outcome measures (3)
- Change in knee pain [Time frame: 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)]
- 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)]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- History of knee replacement surgery in the painful/affected knee(s)
- 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
- 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)
- Previous use of a knee sleeve/fabric knee support on the affected knee(s) for over 6 months cumulative time
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
United States · 1 center
- RAYUS Radiology — Springfield
Identifiers
NCT: NCT07674901 · WCG IRB Study Number 1404409