Abstract
BACKGROUND: Low back pain (LBP) is the most prevalent musculoskeletal condition. Guidelines advocate a multimodal approach, including prescription of medications. Advanced Physiotherapy Practitioners (APPs) are well placed to manage LBP. To date no trial has evaluated the efficacy of physiotherapist-prescribing for LBP. OBJECTIVES: To evaluate the feasibility, suitability and acceptability of assessing the effectiveness of physiotherapist-prescribing for LBP in primary care; informing the design of a future definitive stepped-wedged cluster trial (SWcRCT). METHODS: Mixed-methods, single-arm feasibility design with two components. 1) Trial component: participants with medium-risk LBP +/-leg pain were recruited across 3 sites. Outcome measures (primary outcome measures-Pain/RMDQ) were completed at baseline, 6 and 12 weeks Physical activity/sedentary behaviour were assessed over 7 days using accelerometery. A CONSORT diagram analysed recruitment/follow-up rates. Descriptive analysis evaluated procedure/floor-effects. 2) Embedded qualitative component: focus groups (n = 6) and semi-structured interviews (n = 3) evaluated the views/experiences of patients and APPs about feasibility/suitability/acceptability of the proposed trial. Thematic analysis synthesised the qualitative data. Findings were evaluated against a priori success criteria. RESULTS: n = 29 participants were recruited. 90% of success criteria were met. Loss to follow-up at 12 weeks (65.5%) did not satisfy success criteria. Primary and secondary outcome measures were suitable and acceptable with no floor effects. The addition of a sleep assessment tool was advised. Accelerometer use was acceptable with 100% adherence. APPs felt all patients presenting with non-specific LBP +/- leg pain and capture data representative of the full scope of physiotherapist independent prescribing should be included. Data collection methods were acceptable to APPs and patients. APPs advocated necessity for using research assistants owing to time limitations. CONCLUSIONS: Methods evaluated are feasible, suitable and acceptable for a definitive SWcRCT, with modification of eligibility criteria, and use of research assistants to overcome limited clinician capacity. A definitive SWcRCT is feasible with minor modifications. REGISTRATION: ISRCTN15516596.