Every year, around 24,000 people in the UK break the top of their upper arm bone near the shoulder—a proximal humerus fracture—and most are treated without surgery, relying on a sling and physiotherapy. The problem is that attending 4 to 8 physiotherapy appointments is a major burden: patients cannot drive, struggle with public transport, and depend on family or carers to get there. Physiotherapy also represents the largest healthcare cost for these patients. This trial tests whether a high-quality self-directed rehabilitation programme—where patients manage their own recovery at home using clear advice—works as well as supervised physiotherapy. The researchers will recruit 1,214 adults across at least 24 NHS hospitals, randomly assigning them to either standard physiotherapy or self-directed care, and measure shoulder function and symptoms after six months. If self-directed rehabilitation proves non-inferior, it could transform aftercare for a common injury: patients regain independence, reduce strain on carers, and the NHS saves on clinic resources. The findings will directly inform NICE guidelines and be shared freely with the NHS.
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Research question Is self-directed rehabilitation non-inferior to physiotherapist-supervised rehabilitation in terms of shoulder symptoms and function for adults with non-surgically managed proximal humerus fractures? Background Approximately 24,000 people suffer a proximal humerus fracture in the UK each year, resulting in sudden life-changing reductions in physical function. Most people have non-surgical management, with a sling being applied initially. Shoulder pain and stiffness are prolonged after this injury. Standard practice is to refer patients for physiotherapy, involving 4 to 8 clinic appointments. However, people report finding it difficult to attend physiotherapy. Driving is not possible after this injury and public transport can be a struggle. To attend appointments people become reliant on family, friends and carers. Physiotherapy represents the largest healthcare cost for patients treated non-surgically. Provision of high-quality advice to support self-directed rehabilitation could be an alternative to attending physiotherapy appointments. Enabling people to manage their own recovery could be less of a burden for patients and use less healthcare resources, research in other areas suggest patients find this approach acceptable. Objective The primary objective is to quantify and draw inferences on differences in shoulder symptoms and function, as measured by the Oxford Shoulder Score (OSS), at 6 months post-randomisation between treatment groups. Methods Design: Multi-centre, non-inferiority randomised trial with an internal pilot and parallel economic evaluation. Setting: Trauma/physiotherapy departments at a minimum of 24 NHS hospitals. Participants: 1214 adults with non-surgically managed proximal humerus fractures. Randomisation: 1:1 allocation, within four weeks of fracture, using a centralised computer randomisation service using minimisation, stratified by age (<50/=50yrs) and centre. Control: Physiotherapist-supervised rehabilitation (standard care). Intervention: Self-directed rehabilitation (provision of high-quality self-management advice). Data collection: clinical outcomes (OSS, PROMIS Upper Extremity Function, Self-Efficacy for Exercise Scale, complications), resource use and health-related quality of life (EQ-5D-5L) data will be collected from participant questionnaires and hospital records at baseline and, 2, 4 and 6 months post-randomisation. Primary analysis: mixed-effects linear regression model with adjustments for stratification factors, sex and baseline (pre-injury) score and incorporating data from all time points. PPI: This research addresses two of the top three priorities from a James Lind Alliance Priority Setting Partnership. The eight PPI Advisory Group members contributed to the design. Two PPI co-applicants will be on the trial management team. Timelines for delivery 8 months set-up, 9 pilot, 16 main recruitment, 7 complete follow-up, 6 analysis and reporting. Anticipated impact and dissemination Findings will be shared in open access journals and conferences. PPI co-investigators will support development of summaries, an explainer animation, and actively reaching patient networks. This study will provide the first robust clinical-effectiveness evidence regarding self-directed versus supervised rehabilitation for people with proximal humerus fractures and will inform NICE guideline NG38. Intervention delivery and training materials will be made freely available to the NHS.
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