Stepped rehabilitation of people with persistent shoulder pain in New Zealand (StePS-NZ): a randomised clinical trial protocol.

BACKGROUND: Rotator cuff-related shoulder pain (RCRSP) is a common musculoskeletal disorder, with prevalence increasing with age. In Aotearoa New Zealand, many people with RCRSP are compelled to seek physiotherapy privately as hospital outpatient clinics have long waiting lists, or go without care. We test the efficacy of Stepped Care, a new approach to RCRSP primary care, to use resources as efficiently as possible. This study aims to (i) define the effectiveness of a Stepped Care Model for persistent RCRSP compared to usual, pragmatic physiotherapy; (ii) explore patients' and the physiotherapists' perspectives and experiences of the interventions and research processes; and (iii) compare the cost-effectiveness of the Stepped Care Model with pragmatic physiotherapy. METHODS: This pragmatic, two-armed parallel-group randomised clinical trial will enrol 200 adults with RCRSP, who are randomised to receive either Usual Physiotherapy or Stepped Care. In the Stepped Care group, all patients receive two 1-h sessions focussing on patient education. After 6 weeks, those with persistent symptoms receive pragmatic physiotherapy, while those whose symptoms have resolved will receive no further intervention. The Usual Physiotherapy group receives up to 10 sessions of pragmatic care over a 3-month period. The primary outcome is upper limb function and severity of symptoms using the QuickDASH at 3 months. Secondary outcomes includes pain severity, pain-related fear, pain self-efficacy and health-related quality of life, assessed at baseline, 6 weeks, 3, 6, and 12 months. Outcome measures in continuous scale, including QuickDASH, will be analysed to estimate the difference in the measure between two physiotherapy treatments, while the measures in categorical/binary scales will be analysed to estimate the differences of proportions with favourable outcomes. Confidence intervals will be used to make noninferiority interpretations. A cost-effectiveness analysis will be conducted at the individual level and reported from a societal perspective. DISCUSSION: If the findings from this study support a stepped care approach to treatment for RCRSP, it could lead to more treatment being available at lower cost to both individuals and the health system. TRIAL REGISTRATION: Universal Trial Number: U1111-1298-4087. Australian New Zealand Clinical Trial registration: ACTRN12624000163505, 21st February 2024.