Recipient organisationStaffordshire and Stoke-on-Trent Integrated Care Board
Funding£1.8M
PeriodSept 2018 — May 2024
In plain English
AI plain-English summary
A large trial will test whether adding a medical knee brace to standard physiotherapy care helps people with knee osteoarthritis feel better and move more easily. Knee osteoarthritis affects millions of UK adults, causing pain, stiffness, and difficulty walking. Current NHS treatment focuses on exercise, weight management, and pain relief, but many patients still struggle. Braces are available but rarely prescribed, partly because there is no strong evidence that they work or are worth the cost. This trial aims to fill that gap. If the brace group shows meaningful improvements in pain, function, and quality of life at six months, the NHS could have a new, low-cost treatment option. That would change everyday life for people who currently limit activities or consider knee replacement surgery. The trial also includes an economic analysis, so funders will know whether the benefits justify the cost. If braces prove ineffective, the NHS can avoid wasting money on them. The study will recruit 434 patients across multiple NHS physiotherapy services, with results expected within four years.
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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.
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