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NCT Number: NCT07674901

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.

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Key information

Age range

50 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

RAYUS Radiology

Springfield, Massachusetts, 01107, United States

Location contact

Anthony R Jeanmenne, MD, RAYUS Radiology

SUB_INVESTIGATOR

David F Ransohoff, MD, UNC Chapel Hill

SUB_INVESTIGATOR

Jeffrey T Spang, MD, Wake Forest University

SUB_INVESTIGATOR

Margaret L Gourlay, MD, MPH

CONTACT

[email protected]

413-213-4655

Margaret L Gourlay, MD, MPH

PRINCIPAL_INVESTIGATOR

Victor S Ritter, PhD, Stanford University

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Knee sleeve

Device

Daily use of one of the following:

  • Mueller 4-way Stretch Knee Support
  • Mueller FIR Knee Support
  • PhysFlex Knee Brace

Primary outcomes

  1. Change in radiographic grade of knee osteoarthritis severity

    Time frame: Change from baseline at 5 years

    Kellgren-Lawrence radiographic grade 0 (best) to 4 (worst) on standing/weightbearing anterior/posterior (A/P) knee radiograph

Secondary outcomes

  1. Change in knee pain

    Time frame: Change from baseline at 1 year (also assessed at 3 months and annually years 2-5)

    Knee injury and Osteoarthritis Outcome Score (KOOS) pain subscore

    The KOOS pain subscale includes 9 questions with 5 answer options each, scored from 0 (no knee problems) to 4 (extreme knee problems). The sum of the items is transformed to a 0-100 scale, with 0 representing extreme knee problems and 100 representing no knee problems.

  2. Change in knee function

    Time frame: Change from baseline at 1 year (also assessed at 3 months and annually years 2-5)

    KOOS activities of daily living subscore

    The KOOS activities of daily living function subscale includes 17 questions with 5 answer options each, scored from 0 (no knee problems) to 4 (extreme knee problems). The sum of the items is transformed to a 0-100 scale, with 0 representing extreme knee problems and 100 representing no knee problems.

  3. 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)

    KOOS quality of life subscore

    The KOOS quality-of-life subscale includes 4 questions with 5 answer options each, scored from 0 (no knee problems) to 4 (extreme knee problems). The sum of the items is transformed to a 0-100 scale, with 0 representing extreme knee problems and 100 representing no knee problems.

Other outcomes

  1. Proportion of participants with incident arthroscopic knee procedure or knee replacement surgery

    Time frame: Change from baseline at 5 years

    Participant report or medical documentation of arthroscopic knee procedure or knee replacement surgery

  2. Proportion of participants with patellar instability

    Time frame: Change from baseline at 5 years

    Radiographic signs of patellar instability including: 1) patellar tilting, 2) lateral patellar subluxation, 3) interval patellofemoral joint space narrowing by year 5, 4) Insall-Salvati ratio >1.2 (Patella alta)

Study contacts

Contact information is provided by the study sponsor or research team.

Margaret L Gourlay, MD, MPH

CONTACT

[email protected]

413-213-4655

Sponsors and collaborators

Lead sponsor

Margaret L Gourlay, MD, MPH

Other

Collaborators

  • Knee Sleeve Trial Collaborative, LLC

Registry information

Official study title

A Superiority Randomized Controlled Trial of Daily Knee Sleeve Use Versus No Use in Older Adults With Chronic Knee Pain

Important dates

Study start
2026
Primary completion
2032
Study completion
2032
First posted
Jun 30, 2026
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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