Clinical and cost-effectiveness of bracing in symptomatic knee osteoarthritis management: protocol for a multi-centre, primary care, randomised, parallel-group, superiority trial

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Authors

  • Melanie A Holden
  • Michael Callaghan
  • David Felson
  • Fraser Birrell
  • Elaine Nicholls
  • John McBeth
  • Belinda Borrelli
  • Clare Jinks
  • Nadine Foster
  • Krysia Dziedzic
  • Christian D. Mallen
  • Carol Ingram
  • Alan Sutton
  • Sarah Lawton
  • Nicola Halliday
  • Liz Hartshorne
  • Helen Williams
  • Rachel Browell
  • Hannah Hudson
  • Michelle Marshall
  • Gail Sowden
  • Dan Herron
  • George Peat

Colleges, School and Institutes

Abstract

Background: Brace effectiveness for knee osteoarthritis (OA) remains unclear and international guidelines offer conflicting recommendations. Our trial will determine the clinical and cost-effectiveness of adding knee bracing (matched to patients’ clinical and radiographic presentation and with adherence support) to a package of advice, written information and exercise instruction delivered by physiotherapists.
Methods and analysis: A multi-centre, pragmatic, two-parallel group, single-blind, superiority, randomised controlled trial with internal pilot and nested qualitative study. 434 eligible participants with symptomatic knee OA identified from general practice, physiotherapy referrals and self-referral will be randomised 1:1 to advice, written information and exercise instruction and knee brace versus advice, written information and exercise instruction alone. The primary analysis will be intention-to-treat (ITT) comparing treatment arms on the primary outcome (KOOS-5) (composite knee score) at the primary endpoint (6-months) adjusted for pre-specified covariates. Secondary analysis of KOOS subscales (pain, other symptoms, activities of daily living, function in sport and recreation, knee-related quality of life), self-reported pain, instability (buckling), treatment response, physical activity, social participation, self-efficacy, and treatment acceptability will occur at 3-,6-, and 12-months post randomisation. Analysis of covariance and logistic regression will model continuous and dichotomous outcomes, respectively. Treatment effect estimates will be presented as mean differences or odds ratios with 95% confidence intervals. Economic evaluation will estimate cost-effectiveness. Semi-structured interviews to explore acceptability and experiences of trial interventions will be conducted with participants and physiotherapists delivering interventions.
Ethics and dissemination: North West Preston Research Ethics Committee, the Health Research Authority (HRA) and Health and Care Research in Wales (HCRW) approved the study (REC Reference: 19/NW/0183; IRAS Reference: 247370). This protocol has been coproduced with stakeholders including patients and public. Findings will be disseminated to patients and a range of stakeholders.
Trial registration: ISRCTN28555470
Keywords: osteoarthritis; braces; advice; exercise; randomised controlled trial; knee; physiotherapy; pain; function

Bibliographic note

Funding: This project is funded by the NIHR Health Technology Assessment programme (16/160/03). CM is funded by the National Institute for Health Research (NIHR) Applied research Collaborations (West Midlands), the NIHR School for Primary Care Research and an NIHR Research Professorship in General Practice (NIHR-RP-2014-04-026). KD is part funded by the National Institute for Health Research (NIHR) Applied Research Centre (ARC) West Midlands (NIHR200165) and is an NIHR Senior Investigator (NIHR200259). NEF was funded by an NIHR Research Professorship (NIHR-RP-2011-015) and is an NIHR Senior Investigator. CJ is part funded by the NIHR Applied Research Centre (ARC) West Midlands (NIHR200165). The trial described in the manuscript has had no financial support from commercial sources, however, a proportion of the braces supplied by Ossur are being donated and we have received a discounted price on braces supplied by other companies.

Details

Original languageEnglish
Article numbere048196
JournalBMJ open
Volume11
Issue number3
Early online date26 Mar 2021
Publication statusE-pub ahead of print - 26 Mar 2021