Title: Acute Rehabilitation following Traumatic anterior shoulder dISlocAtioN (ARTISAN)- A Multi Centre RCT
Funder: Department of Health and Social Care

Abstract: 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, 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. 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)

Lay abstract: Background: Shoulder dislocations occur when the upper end of the arm bone is forced out of its joint socket because of a traumatic event. It is common, affecting 24 people per 100,000 annually. It occurs mostly in men in their twenties and women aged over eighty. We are an aging population; consequently, shoulder dislocations are becoming more common. The injury results in pain, disability and decreased function. The majority of patients are managed without an operation. There are no trials in existence that compare different non operative management options. Currently in the UK, some hospitals offer a single session of advice and some offer a course of physiotherapy. The UK guidelines currently say a course of physiotherapy ‘may be helpful’; whilst other national guidelines say advice alone is needed. A single session of advice versus a course of physiotherapy has substantial impact for NHS resources, and patient’s. There is a huge burden on both if patients are required to attend an outpatient clinic on a regular basis for an intervention that may not have any value above a single session of advice. Aim: We plan to perform a study across 30 UK hospitals to compare a single session of advice versus a course of physiotherapy for patients who have dislocated their shoulder. Design: The first phase will confirm if we can recruit 50 patients to the study in six months across 12 hospitals. This will allow us to implement successfully the main phase across 30 UK hospitals in which 478 patients will be randomly allocated to receive a single session of advice or a course of physiotherapy. All adult patients with a dislocated shoulder managed without an operation will be screened. All participants who are eligible and consent to take part will be allocated by chance to either a single session of advice or the same session followed by a course of physiotherapy. Both treatments are widely used, and clinical teams across the UK will be familiar with both. The primary aim is to compare the two treatment groups for differences in the Oxford Shoulder Instability Score six months after injury. This score measures function from the patients’ perspective. Improvements in functional outcome and quality of life as well as complications and resource use will be collected at six weeks, three, six and 12 months after taking part in the study. Patient and public involvement: Patients were consulted during appointments to ascertain if the research gaps highlighted in the literature were of high importance to them. These same patients were invited to a workshop and asked if they would be interested in a consultation role for further development of the study and future roles in management of the research and dissemination of findings. These perspectives were key in the development of the protocol to ensure trial processes, materials and interventions are feasible and acceptable. Dissemination: The results are planned to be presented at national conferences, published in high quality journals and social media outlets as well as websites such as patient.co.uk. Lay team members will be supported to produce lay summaries of the research to be disseminated across the trial sites and individual trial participants.

Research activity codes: 6.7 PHYSICAL
Health categories: INJURIES AND ACCIDENTS