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Daily Knee Sleeve Use Versus No Use in Older Adults With Chronic Knee Pain

30. juni 2026 opdateret af: Margaret L Gourlay, MD, MPH

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

235

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Forenede Stater
    • Massachusetts
      • Springfield, Massachusetts, Forenede Stater, 01107
        • RAYUS Radiology
        • Kontakt:
        • Ledende efterforsker:
          • Margaret L Gourlay, MD, MPH
        • Underforsker:
          • Victor S Ritter, PhD, Stanford University
        • Underforsker:
          • Anthony R Jeanmenne, MD, RAYUS Radiology
        • Underforsker:
          • David F Ransohoff, MD, UNC Chapel Hill
        • Underforsker:
          • Jeffrey T Spang, MD, Wake Forest University

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Knee sleeve
Daily knee sleeve use
Enhed: Knee sleeve

Daily use of one of the following:

  • Mueller 4-way Stretch Knee Support
  • Mueller FIR Knee Support
  • PhysFlex Knee Brace
Ingen indgriben: Control
No knee sleeve use

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in radiographic grade of knee osteoarthritis severity
Tidsramme: Change from baseline at 5 years
Kellgren-Lawrence radiographic grade 0 (best) to 4 (worst) on standing/weightbearing anterior/posterior (A/P) knee radiograph
Change from baseline at 5 years

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in knee pain
Tidsramme: 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.
Change from baseline at 1 year (also assessed at 3 months and annually years 2-5)
Change in knee function
Tidsramme: 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.
Change from baseline at 1 year (also assessed at 3 months and annually years 2-5)
Change in knee-related quality of life
Tidsramme: 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.
Change from baseline at 1 year (also assessed at 3 months and annually years 2-5)

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Proportion of participants with incident arthroscopic knee procedure or knee replacement surgery
Tidsramme: Change from baseline at 5 years
Participant report or medical documentation of arthroscopic knee procedure or knee replacement surgery
Change from baseline at 5 years
Proportion of participants with patellar instability
Tidsramme: 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)
Change from baseline at 5 years

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Margaret L Gourlay, MD, MPH

Samarbejdspartnere

Knee Sleeve Trial Collaborative, LLC

Efterforskere

  • Ledende efterforsker: Margaret L Gourlay, MD, MPH, Knee Sleeve Trial Collaborative, LLC

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. september 2026

Primær færdiggørelse (Anslået)

1. september 2032

Studieafslutning (Anslået)

1. september 2032

Datoer for studieregistrering

Først indsendt

22. juni 2026

Først indsendt, der opfyldte QC-kriterier

26. juni 2026

Først opslået (Faktiske)

30. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

1. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • WCG IRB Study Number 1404409

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ja

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

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Kliniske forsøg med Knæ Arthritis, Slidgigt

Kliniske forsøg med Knee sleeve

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