Acute Rehabilitation following Traumatic anterior shoulder dISlocAtioN (ARTISAN)- A Multi Centre RCT

Background: First time traumatic anterior shoulder dislocation (TASD) has an incidence of 23.9 per 100,000 annually. It mostly affects males in their twenties and females over eighty. Non operative management is first line care, there are no RCTs evaluating the optimum non operative care. Design and Setting: Internal Pilot: Evaluate expected recruitment of 50 patients within six months at 12 sites; Main Phase: Multi centre, adaptive, two arm, RCT, with 1:1 treatment allocation, stratified by age, hand dominance and centre at 30 trauma sites. Target Population: Inclusion: Non-operatively managed, first time TASD, receiving rehabilitation within six weeks of injury. Exclusion: Under 18 years; having first line surgical treatment; neurovascular complication; previous randomisation. Health Technology: Trial arms were refined through literature review, telephone survey of physiotherapists, surgeon consensus meeting and a PPI workshop. This has ensured best practice is feasible and scientifically grounded. It is current practice to offer either advice alone or a physiotherapy course. Control: Up to two weeks of immobilisation and intervention within six weeks by trained physiotherapists. All patients will receive a single session of advice to aid self-management. Lasting up to one hour; education on the injury, common complications and how to prevent, pain relief and exercises will be discussed, supported by different media. Comparator: Course of physiotherapy (Minimum of two sessions offered)for up to 30 minutes, over four months. It will be tailored, supervised and taught incorporating common methods to increase adherence. Participants will be randomized following completion of the control intervention. Measurement of Costs and Outcomes: Baseline demographics, pre and post injury functional and health related quality of life outcomes will be collected using the Oxford Shoulder Instability Score, the EQ-5D-5L and QuickDASH by a research associate. They will be collected by post at six weeks, three, six and 12 months post randomisation alongside resource use questionnaires and complications. An embedded qualitative component will explore views of the interventions on completion of the research. Sample Size: A computer generated 1:1 randomisation sequence, stratified by centre, hand dominance and age, will be produced and administered independently. Allowing for 20% loss to follow-up randomising 478 patients will provide 90% power to detect a difference of 4 points, with SD 12 points on the OSIS at six months at the 5% level. Interim (adaptive) analysis: A single interim analysis is pre-planned to re-estimate the sample size required. This will occur after approximately 200 participants have completed the three month follow up questionnaire, whilst recruitment is still open. The standard deviation of the primary outcome and presence of therapist effects will be estimated and the sample size calculation updated. This revised figure will be discussed with DMC and TSC and if appropriate, permission requested from the funder to increase the sample size. Analysis: Primary analysis will investigate differences between groups on the OSIS at six months using a linear regression model containing group, centre and age as covariates. Secondary analyses will include comparisons of dislocation rates, other secondary functional and quality of life outcomes at each time point and a descriptive subgroup analysis based on effect of age and the intervention. The cost-effectiveness of treatment will be assessed as a cost/QALY, initially using a within-trial analysis and extending to an extrapolated model if necessary. Team: PPI, surgeons, physiotherapists, health psychologists, statisticians, health economists and clinical trialist will provide relevant expertise. Project Milestones (Month):Set up and internal pilot (01-11); recruitment (06-27); primary end follow up (33); secondary end follow up (39); analysis and dissemination (34- 42)