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

Condition(s) studied

Investigational drug(s) / intervention(s)

Personalised, Multimodal Educational Intervention: Participants receive a personalised, multimodal educational intervention over a maximum of 12 weeks. Delivery may combine a written educational guide, a study website hosting video resources, and up to eight individual educational consultations of approximately 30 minutes. The content and the combination of components are agreed between participant and physiotherapist through shared decision making. No structured therapeutic exercise programme is prescribed, and participants in this group do not receive usual physiotherapy care in addition. The intervention aims to improve understanding of shoulder pain, self-management skills, confidence in movement and return to normal activities.

Usual Physiotherapy Care: Participants receive usual physiotherapy care over a maximum of 12 weeks, comprising up to eight supervised consultations of approximately 30 minutes delivered according to current clinical practice. Treatment may combine therapeutic exercise, verbal education, manual therapy and other adjunctive treatments in routine use, at the discretion of the treating physiotherapist.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Change in Shoulder Pain and Disability Index (SPADI) total Score — Baseline to Week 12
  The Shoulder Pain and Disability Index (SPADI) is a 13-item participant-reported questionnaire comprising a five-item pain subscale and an eight-item disability subscale. Items are combined and transformed into a total score ranging from 0 to 100, with higher scores indicating greater shoulder pain and disability. The primary endpoint is the between-group difference in SPADI score change from baseline to Week 12.

Trial sites (1)

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