Current guideline-based care supported by a physiotherapist versus provision of a high-quality information leaflet and a single advice session delivered by a physiotherapist for people with shoulder osteoarthritis: A pilot randomised controlled trial with embedded qualitative study.

Background Shoulder osteoarthritis is a debilitating condition causing pain, restricted movement, and limited function. It is becoming more common as our population ages. Current NICE guidance on the non-surgical management of people with osteoarthritis recommends treatment including therapeutic exercise, weight management, advice about osteoarthritis and anti-inflammatory medication. Physiotherapists are well-positioned within the NHS to support this treatment. However, these guidelines are based on research from people with hip and knee osteoarthritis, and not specifically the shoulder. Unlike the hip and knee, most functional activities performed with the shoulder are non-weight-bearing and it is uncertain whether these recommendations are effective for people with shoulder osteoarthritis. As a result, a key recommendation from these NICE guidelines is to establish their clinical and cost-effectiveness for shoulder osteoarthritis. Given the personal burden of shoulder osteoarthritis on the NHS and the rising prevalence, there is an urgent need to know whether current guideline-based care supported by physiotherapists for people with shoulder osteoarthritis is clinically and cost-effective. Research Question Is it feasible to conduct a future, fully powered randomised controlled trial (RCT), comparing current guideline-based care supported by a physiotherapist, to a high-quality information leaflet and a single advice session delivered by a physiotherapist, for adults with shoulder osteoarthritis? Methods Pragmatic, multi-centre pilot RCT with an embedded qualitative study in physiotherapy clinics at three NHS trusts. A total of 70 adults with clinically diagnosed shoulder osteoarthritis will be randomly allocated on a 1:1 basis to current guideline-based care supported by a physiotherapist OR provision of a high-quality information leaflet and a single advice session delivered by a physiotherapist. Current guideline-based care supported by a physiotherapist, includes therapeutic exercise, weight management, advice and information about osteoarthritis, including advice about pain relief. The comparator will include provision of a high-quality information leaflet, based on information sources currently provided by NHS Trusts, along with a single session of advice, to facilitate self-management, delivered by a physiotherapist. Feasibility outcomes will include recruitment rate and acceptance of treatment allocation, treatment fidelity and follow-up outcome measure completion rates. A descriptive analysis of this data will be undertaken. Clinical outcomes will include the Shoulder Pain and Disability Index and EQ-5D-5L. Qualitative interviews will explore the acceptability and experience of participants in both groups and will be analysed using Braun and Clarke's six stage model of thematic analysis. Timeline 36 months: Nine months for intervention refinement, protocol finalisation and approvals. 12 months for recruitment. Six months for follow-up. Nine months for analysis and reporting. Anticipated Impact and dissemination The pilot RCT and embedded qualitative study are important first steps in establishing the feasibility of a future full RCT evaluating the effectiveness of current guideline based care supported by a physiotherapist. Although this proposed research will not have immediate clinical implications, the results will be disseminated widely via publications and presentations at national and international conferences. We will use social media to engage stakeholders and produce easy to understand blogs and papers, supported by PPIE members, to ensure understandable and accessible results.