IMPETUS- optIMal Physiotherapy for nEurogenic Thoracic oUtlet Syndrome

Background Neurogenic Thoracic Outlet Syndrome (NTOS) is a disabling and rare upper limb condition, for which specialist physiotherapy intervention is deemed the 'mainstay' of conservative management.

Despite this, the components of physiotherapy programmes and the population who may benefit is not known or poorly described. Physiotherapy treatments currently vary widely and are sub-optimal. Blended care is a novel way of optimising treatment effectiveness by combing digital components with face-to-face care.

Developing, agreeing and testing an optimal blended physiotherapy intervention for NTOS could improve accessibility to specialist physiotherapy, treatment outcomes and be more cost effective for the NHS.

Objectives Identify key physiotherapy rehabilitation interventions for NTOS, and their efficacy based the current evidence Develop an optimal blended physiotherapy intervention for NTOS Determine whether the optimal blended physiotherapy intervention is deliverable and whether a future primary RCT evaluating the clinical and cost-effectiveness of the optimal package vs usual care is feasible To understand the barriers to, enablers of, and acceptability of the optimal blended physiotherapy intervention from end-users Method Mixed methods research project involving three phases.

Co-production with service users underpin all aspects of the proposed research.

Phase 1: Systematic review (SR) of available literature on the components of physiotherapy interventions for NTOS Phase 2: A consensus exercise using Nominal Group Techniques involving 10-15 key stakeholders to agree an optimal blended physiotherapy intervention for NTOS, based on best available evidence for use in the NHS, using an iterative process.

The blended intervention will then be developed along with educational resources for physiotherapists with an existing digital health delivery platform (Physitrack). Phase 3: A multi-centre pilot and feasibility randomised controlled trial (RCT) with nested Qualitative study.

To determine whether the optimised blended intervention is;a) acceptable to end users, b) can be delivered and if a future full RCT is feasible. Participants: For the RCT, 40 Adults with NTOS from specialist Peripheral Nerve Injury / vascular clinics in the NHS.

For the qualitative interviews, 4-8 patients and 3-5 physiotherapists Intervention/control: Random allocation to either a) Optimal blended intervention b) Usual Physiotherapy care Clinical Outcomes: 1) QuickDASH 2) Cervical Brachial Symptom Questionnaire (CBSQ) 3) Short Form 12 (SF-12)- measured at baseline, 6 weeks, 3 and 6 months Feasibility /Acceptability /Usability outcomes: 1) Recruitment rate 2) Retention rate 3) Ability to collect data via PROMS 4) Adherence to treatment (Fidelity) -measured at end of study 5) Overall satisfaction of Treatment (Likert scale) 6) Patient /Physiotherapist- System Usability Scale (SUS)- measured at 3 months Nested Qualitative method: Semi-structured interviews on acceptability of the blended intervention using thematic analysis Anticipated Impact Outputs from each phase of the project will be disseminated in peer-reviewed journals, conferences, lay press and social media.

Intellectual property of the digital components produced for the blended intervention, will be retained by the research team, creating potential for future scalability and commercialisation, maximising this projects potential global reach.

Personal development as a future NIHR research leader with skills and experience in SR, consensus, qualitative methodologies, and design / delivery of a RCT.