Clinical Research Directory

Personalised Education Versus Usual Physiotherapy for Acute Rotator Cuff-Related Shoulder Pain

Rotator cuff-related shoulder pain (RCRSP) is one of the most common musculoskeletal disorders presenting in primary care. It is frequently associated with persistent pain, disability, healthcare utilisation and work absenteeism. Exercise-based physiotherapy is recommended as first-line management in clinical practice guidelines, yet its average effects on pain and disability are modest and a substantial proportion of people remain symptomatic several months after onset. Patient education is also recommended, and trials conducted in people with persistent symptoms suggest that education-based care may produce improvements comparable to those obtained with progressive exercise. However, the effectiveness of a structured educational intervention as a first-line management strategy during the acute phase of RCRSP remains unclear. SHOULD Education lead Rehabilitation? (SHOULD-ER) is a multicentre, pragmatic, parallel-group, non-inferiority randomised controlled trial comparing a personalised, multimodal educational intervention with usual physiotherapy care in adults presenting with acute non-traumatic RCRSP of less than six weeks duration. Participants will be randomly assigned to one of the trial arms for a 12-week treatment period, with follow-up to 24 weeks. The primary objective is to determine whether the educational intervention is non-inferior to usual physiotherapy care regarding improvement in shoulder pain and disability at 12 weeks, measured by the Shoulder Pain and Disability Index (SPADI). Secondary outcomes include pain-related function, self-efficacy, fear-avoidance beliefs, quality of life, sleep quality, patient satisfaction and healthcare costs. A nested qualitative study and a within-trial economic evaluation are embedded in the trial. An exploratory analysis of prognostic factors will also be conducted with a secondary analysis.