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

Melanie A Holden, Michael Callaghan, David Felson, Fraser Birrell, Elaine Nicholls, Sue Jowett, Jesse Kigozi, 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 BrowellHannah Hudson, Michelle Marshall, Gail Sowden, Dan Herron, Evans Asamane, George Peat

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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

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

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