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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 50 Years and 64 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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 Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Superiority Randomized Controlled Trial
Primary Purpose
Prevention
Masking
Single (Outcomes Assessor)
Masking Description
Research Radiologist (Assessor of Primary Outcome and other radiographic outcomes) is masked to the randomization assignments

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Knee sleeve 		Daily knee sleeve use
  • Device: Knee sleeve
    Daily use of one of the following: - Mueller 4-way Stretch Knee Support - Mueller FIR Knee Support - PhysFlex Knee Brace
No Intervention
Control 		No knee sleeve use

Recruiting Locations

RAYUS Radiology
Springfield, Massachusetts 01107
Contact:
Margaret L Gourlay, MD, MPH
413-213-4655
info@kneesleevetrial.org

More Details

Status
Recruiting
Sponsor
Margaret L Gourlay, MD, MPH

Study Contact

Margaret L Gourlay, MD, MPH
413-213-4655
info@kneesleevetrial.org

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.