Independent prescribing by advanced physiotherapists for patients with low back pain in primary care: protocol for a feasibility trial with an embedded qualitative component.

TLDR: It is anticipated that the results of this study will be used in conjunction with ethical evaluation, economic and risk analyses, as well as consultation with key stakeholders including the British health consumer when contemplating change, enhancement or redesign of the essential full randomised controlled trial.

Abstract: Introduction Low back pain (LBP) is the most prevalent musculoskeletal condition in the UK. Guidelines advocate a multimodal approach, including prescription of medications. Advanced physiotherapy practitioners (APPs) are well placed to provide this care in primary care. Physiotherapist independent prescribing remains novel, with the first prescribers qualifying in 2014. This feasibility trial aims to evaluate the feasibility, suitability and acceptability of assessing the effectiveness of independent prescribing by APPs for patients with LBP in primary care, to inform the design of a future definitive stepped-wedged cluster trial. Method and analysis (1) Trial component. An APP (registered prescriber) will complete the initial participant consultation. If prescription drugs are required within the multimodal physiotherapeutic context, these will be prescribed. Patient-reported outcome measures will be completed prior to initial assessment and at 6 and 12 weeks to assess feasibility of follow-up and data collection procedures. Accelerometers will be fitted for 7 days to assess physical activity, sedentary behaviour and feasibility of use. (2) Embedded qualitative component. A focus group and semistructured interviews will be used to evaluate the views and experiences of the participants and APPs respectively, about the feasibility, suitability and acceptability of the proposed full trial. A Consolidated Standards of Reporting Trials diagram will be used to analyse feasible eligibility, recruitment and follow-up rates. Descriptive analysis of the data will be completed to evaluate procedures. Thematic analysis will be used to analyse and synthesise the qualitative data. Ethics and dissemination This feasibility trial is approved by the Health Research Authority (HRA). Ethical approval was sought and granted via the Integrated Research Application System (IRAS) ID 250734. Data will be disseminated via publication in peer reviewed journal and conference presentation. It is anticipated that the results of this study will be used in conjunction with ethical evaluation, economic and risk analyses, as well as consultation with key stakeholders including the British health consumer when contemplating change, enhancement or redesign of the essential full randomised controlled trial. Trial registration number ISRCTN15516596, Pre-results.