Title: PROvision of braces for Patients with knee OsteoArthritis (PROP OA): a randomised controlled trial
Funder: Department of Health and Social Care

Abstract: DESIGN: 12-month, multi-centre, two-arm, parallel-group, randomised (1:1), superiority trial with 9-month internal pilot, and embedded qualitative interviews and focus groups. SETTING: Primary care and community. Treatments delivered in NHS physiotherapy services. TARGET POPULATION: Adults with symptomatic knee OA identified via: GP consultation; screen of physiotherapy referrals; self-referral. HEALTH TECHNOLOGIES BEING ASSESSED Best Primary Care (BP): one treatment session with a physiotherapist to include: education about knee OA and the benefits of exercise/ physical activity and weight loss; simple self help advice on pain management; lower limb home exercise program; written information; asked not to wear knee brace for six months. Best Primary Care plus Bracing with adherence-enhancing component (BP+B): In addition to BP, participants matched by clinical examination and X-ray findings to receive either a patellofemoral, tibiofemoral unloading, or neutral stabilising brace. Brief Motivational Interviewing (MI) will support brace adherence. One follow-up appointment at 2 weeks to check brace fit, and further address brace adherence. Individualised adherence-enhancing motivational prompts sent to participants, tapered over 6 months. MEASUREMENT OF COSTS AND OUTCOMES: Primary outcome: patient-reported composite knee score of pain, other symptoms, activities of daily living, function in sport and recreation and knee-related quality of life (KOOS-5) at 6 months. Secondary outcomes at 3, 6, and 12 months: KOOS subscales; pain; instability (buckling); treatment response; physical activity; social participation; arthritis self-efficacy; knee pain-related perceptions and expectations; anxiety and depression; (serious) adverse events. Time to /need for knee surgery will be explored via linkage to National Joint Registry (NJR) and medical record review. Embedded qualitative work will help to interpret trial findings. A within-trial economic evaluation (cost-utility analysis) BP vs BP+B will estimate cost/QALY gained over 12 months and decision modelling will extrapolate costs and outcomes beyond the trial. SAMPLE SIZE: 434 patients randomised to detect an effect size of 0.35 in KOOS-5 at 6 months with 2-sided 5% significance and 90% power and allowing for 20% loss to follow-up (target n @ 6 months=346; 173/treatment arm). PROJECT TIMETABLES INCLUDING RECRUITMENT RATE Study duration: 51 months. Months 0-6: Pre-trial phase. 7-16: Internal pilot. 7-30: Participant recruitment. 8-37: Intervention delivery. 11-43: Follow-up. 44-50: Data analyses. 46-51: Write up final report. Recruitment rate: We aim to randomise 434 participants over 24 months, phasing in recruitment over the first 3 months (8, 12, and 15 participants respectively, then 19 per month). EXPERTISE IN TEAM: We are a multi-disciplinary team with experience in general practice, physiotherapy, rheumatology, health psychology, biostatistics, health economics, qualitative methods, PPIE. We have internationally-recognised expertise in knee OA, knee bracing, behaviour change and adherence, and RCT design and delivery. We have experienced lay co-applicants with strong institutional PPIE support. Keele CTU has expertise in delivering large RCTs in primary care.

Lay abstract: AIM(S) OF THE RESEARCH: To show whether wearing a knee brace provides more relief for people with painful osteoarthritis of the knee than just having best primary care (education, advice and exercise), and whether this is good value for money for the NHS. BACKGROUND: Osteoarthritis of the knee is very common. It causes pain, problems with walking and movement, and can make daily life very difficult. There is no cure for osteoarthritis, but with treatment, symptoms can be improved allowing people to stay active. Wearing a brace could help patients with osteoarthritis of the knee by reducing the load going through the joint and improving its stability. However, there are mixed reports about whether wearing a knee brace does actually help. DESIGN AND METHODS: We will complete a trial with 434 adults aged 45 or older with osteoarthritis of the knee. We will identify patients after they have consulted their GP with knee pain, by screening physiotherapy referrals in NHS services in Staffordshire, Cheshire, Greater Manchester, and Northumbria, and by asking people to volunteer following local radio and other advertising. All participants in the trial will get “best primary care”. This includes a 20 minute appointment with a physiotherapist who will give them education about knee osteoarthritis and the benefits of exercise, physical activity and weight loss, advice about how to relieve knee pain, and a knee exercise program. They will also be given an information booklet. Half of the participants will also get a knee brace that will be checked by the physiotherapist 2 weeks later. The type of brace they get will be based on the physiotherapist’s assessment and X-ray findings. They will be supported to keep wearing the brace for at least 6 months. This includes text message support to help them with use of the brace. Participants will be asked about their pain and symptoms after 3, 6, and 12-months to see whether the knee brace was a useful addition to best primary care. We will ask participants if we can look at their medical records to see if wearing the knee brace has reduced the need for surgery. We will interview some patients to find out more about using the knee brace and whether they followed the advice they had from physiotherapists. PATIENT AND PUBLIC INVOLVEMENT: Patient representatives will be involved at every stage of the trial. Two patient representatives have joined the study team, and have jointly written this summary. Five patient representatives with knee osteoarthritis also helped in the design of the trial by taking part in a workshop. For example, they helped to decide how pain and symptoms should be measured. Patients will continue to be involved by helping to develop the content of text messages to support brace use, monitoring trial progress, helping to understand interview findings, and developing and delivering messages about the trial findings that are easily understandable to the general public. DISSEMINATION: We will present the findings at national and international meetings, and publish the trial results in high-quality medical journals. We will also show the outcome of the trial on our University and osteoarthritis websites (for example Arthritis Research UK), and in GP practices, which all patients will be advised to look at. Articles about the trial will also be written for local magazines, newspapers radio stations.

Research activity codes: 6.3 MEDICAL DEVICES
Health categories: MUSCULOSKELETAL