Centre of Precision Rehabilitation for Spinal Pain, School of Sport, Exercise and Rehabilitation Sciences, University of Birmingham, Edgbaston, Birmingham, England, United Kingdom.
Physiotherapy Department, St George's University Hospitals Foundation Trust, London, England, United Kingdom.
PLoS One. 2020 Mar 17;15(3):e0229792. doi: 10.1371/journal.pone.0229792. eCollection 2020.
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.
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).
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.
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.
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.
ISRCTN15516596.
下腰痛(LBP)是最常见的肌肉骨骼疾病。指南提倡采用多模式方法,包括开具药物处方。高级物理治疗师(APP)非常适合管理 LBP。迄今为止,尚无试验评估物理治疗师处方治疗 LBP 的疗效。
评估在初级保健中评估物理治疗师处方治疗 LBP 效果的可行性、适宜性和可接受性;为未来的确定性分步楔形集群试验(SWcRCT)提供信息。
混合方法,具有两个组件的单臂可行性设计。1)试验组件:在 3 个地点招募中危 LBP +/-腿部疼痛的参与者。在基线、6 周和 12 周时完成结局测量(主要结局测量-疼痛/RMDQ)。使用加速度计在 7 天内评估体力活动/久坐行为。CONSORT 图分析了招募/随访率。描述性分析评估了程序/地板效应。2)嵌入式定性组件:焦点小组(n=6)和半结构化访谈(n=3)评估了患者和 APPs 对拟议试验的可行性/适宜性/可接受性的看法/经验。主题分析综合了定性数据。结果根据事先确定的成功标准进行评估。
共招募了 29 名参与者。90%的成功标准得到满足。12 周时的失访率(65.5%)未满足成功标准。主要和次要结局测量具有适宜性和可接受性,没有地板效应。建议添加睡眠评估工具。加速度计的使用可接受,依从性为 100%。APPs 认为所有出现非特异性 LBP +/-腿部疼痛的患者以及能够捕捉到物理治疗师独立处方全部范围数据的患者都应纳入。数据收集方法得到 APPs 和患者的认可。APPs 主张由于时间限制,需要使用研究助理。
经过修改纳入标准和使用研究助理以克服临床医生能力有限,评估的方法对于确定性 SWcRCT 是可行的、适宜的和可接受的。通过微小修改,可以进行确定性 SWcRCT。
ISRCTN80434203。