Clinical and cost-effectiveness of a personalised guided consultation versus usual physiotherapy care in people presenting with shoulder pain: a protocol for the PANDA-S cluster randomised controlled trial and process evaluation.

INTRODUCTION: Musculoskeletal shoulder pain is a common reason for people to be treated in physiotherapy services, but diagnosis can be difficult and often does not guide treatment or predict outcome. People with shoulder pain cite a need for clear information, and timely, tailored consultations for their pain. This trial will evaluate the introduction of a personalised guided consultation to help physiotherapists manage care for individuals with shoulder pain. METHODS AND ANALYSIS: This is a cluster randomised controlled trial to evaluate the clinical and cost-effectiveness of introducing a personalised guided consultation compared with usual UK NHS physiotherapy care. Physiotherapy services (n=16) will be randomised in a 1:1 ratio to either intervention (physiotherapy training package and personalised guided consultation incorporating a new prognostic tool) or control (usual care); 832 participants (416 in each arm) identified from participating physiotherapy service waiting lists aged 18 years or over with shoulder pain will be enrolled. Follow-up will occur at 3 time points: 6 weeks, 6 months and 12 months. The primary outcome will be the Shoulder Pain and Disability Index (SPADI) score over 12 months. Secondary outcomes include global perceived change of the shoulder condition, sleep, work absence and the impact of shoulder pain on work performance, healthcare utilisation and health-related quality of life (using EuroQol 5 Dimension 5 Level (EQ-5D-5L)). A multimethod process evaluation will investigate views and experiences of participants and physiotherapists, assess uptake, facilitators and barriers to delivery, and changes in factors assumed to explain intervention outcomes. Primary analysis of effectiveness will be by intention-to-treat, and a health economic evaluation will assess cost-utility of introducing the personalised consultation. ETHICS AND DISSEMINATION: The trial received ethics approval from the Yorkshire & The Humber (South Yorkshire) Research Ethics Committee (REC reference: 23/YH/0070). Findings will be shared through journal publications, media outlets and conference presentations. Supported by patient contributors and clinical advisors, we will communicate findings through a designated website, networks, newsletters, leaflets and in the participating physiotherapy services. TRIAL REGISTRATION NUMBER: ISRCTN45377604.