TY - JOUR
T1 - Clinical and cost-effectiveness of bracing in symptomatic knee osteoarthritis management
T2 - protocol for a multicentre, primary care, randomised, parallel-group, superiority trial
AU - Holden, Melanie A
AU - Callaghan, Michael
AU - Felson, David
AU - Birrell, Fraser
AU - Nicholls, Elaine
AU - Jowett, Sue
AU - Kigozi, J
AU - McBeth, John
AU - Borrelli, Belinda
AU - Jinks, Clare
AU - Foster, Nadine E
AU - Dziedzic, Krysia
AU - Mallen, Christian
AU - Ingram, Carol
AU - Sutton, Alan
AU - Lawton, Sarah
AU - Halliday, Nicola
AU - Hartshorne, Liz
AU - Williams, Helen
AU - Browell, Rachel
AU - Hudson, Hannah
AU - Marshall, Michelle
AU - Sowden, Gail
AU - Herron, Dan
AU - Asamane, Evans
AU - Peat, George
N1 - Funding Information:
9Faculty of Biology, Medicine and Health, The University of Manchester, Manchester, UK 10Henry M. Goldman School of Dental Medicine, Boston University, Boston, Massachusetts, USA 11School of Health Sciences, Division of Psychology and Mental Health, Manchester Centre for Health Psychology and Manchester Academic Health Science Centre, The University of Manchester, Manchester, UK 12Research User Group, Primary Care Centre Versus Arthritis, School of Medicine, Keele University, Keele, UK Acknowledgements The PROP OA trial is supported by Keele Clinical Trials Unit and sponsored by Keele University (Sponsors office—Directorate of Research, Innovation and Engagement). We would like to acknowledge the help and support of Tina Hadley-Barrows, Lucy Huckfield, Katrina Humphreys, Richard Hodgson, Treena Larkin, Matt Parkes, Neil Porter who were involved in aspects the trial design, drafting of the operational protocol and/or initiating the study set up through to first site opening. We also thank members of the Keele Research User Group, patient representatives and members of the TSC and DMC who supported the design of the trial and who continue to work with the team. Thanks also to members of our Clinical Advisory group for their support in development of the trial interventions, namely Leela Biant, Tina Hadley-Barrows, Katrina Humphreys, Vicky Jeffrey, Treena Larkin, Claire Minshull, Tim Powell, and Samantha Watson-Smith.
Funding Information:
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.
Publisher Copyright:
© Author(s) 2021.
PY - 2021/3/26
Y1 - 2021/3/26
N2 - 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 multicentre, 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 comparing treatment arms on the primary outcome (Knee Osteoarthritis Outcomes Score (KOOS)-5) (composite knee score) at the primary endpoint (6 months) adjusted for prespecified 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 postrandomisation. Analysis of covariance and logistic regression will model continuous and dichotomous outcomes, respectively. Treatment effect estimates will be presented as mean differences or ORs with 95% CIs. Economic evaluation will estimate cost-effectiveness. Semistructured 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 and Health and Care Research in Wales 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 NUMBER: ISRCTN28555470.
AB - 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 multicentre, 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 comparing treatment arms on the primary outcome (Knee Osteoarthritis Outcomes Score (KOOS)-5) (composite knee score) at the primary endpoint (6 months) adjusted for prespecified 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 postrandomisation. Analysis of covariance and logistic regression will model continuous and dichotomous outcomes, respectively. Treatment effect estimates will be presented as mean differences or ORs with 95% CIs. Economic evaluation will estimate cost-effectiveness. Semistructured 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 and Health and Care Research in Wales 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 NUMBER: ISRCTN28555470.
KW - musculoskeletal disorders
KW - primary care
KW - rheumatology
U2 - 10.1136/bmjopen-2020-048196
DO - 10.1136/bmjopen-2020-048196
M3 - Article
C2 - 33771832
SN - 2044-6055
VL - 11
SP - e048196
JO - BMJ Open
JF - BMJ Open
IS - 3
M1 - e048196
ER -