Bateman M, Saunders B, Littlewood C, Davis D, Beckhelling J, Cooper K, Skeggs A, Foster N E, Vicenzino B, Hill J C
University Hospitals of Derby & Burton NHS Foundation Trust, Derby, UK.
School of Medicine, Keele University, Newcastle-under-Lyme, UK.
Pilot Feasibility Stud. 2022 Aug 11;8(1):178. doi: 10.1186/s40814-022-01132-x.
Physiotherapy is recommended for people with tennis elbow, but whilst a wide array of treatments is available, the optimal approach remains uncertain. We have therefore recently developed an optimised physiotherapy treatment package for tennis elbow based on a synthesis of the evidence, patient input and clinical consensus. It consists of detailed advice and education, a structured progressive exercise programme and provision of a counter-force elbow brace. Here, we report the protocol for our multicentre pilot and feasibility randomised controlled trial (RCT) designed to (a) examine the feasibility of our optimised physiotherapy treatment package and (b) to pilot trial processes for a future fully powered RCT to test clinical and cost-effectiveness compared with usual physiotherapy treatment.
A multicentre pilot and feasibility RCT will be conducted across three sites in England, recruiting up to 50 patients (or for a maximum of 12 months). Participants with tennis elbow, identified from physiotherapy clinic waiting lists and general practice surgeries, will be randomly allocated to receive the optimised physiotherapy treatment package or usual physiotherapy care. Analysis will focus on feasibility measures including consent rate, intervention fidelity, follow-up rate and outcome completion rate. A nested qualitative study will explore the acceptability of the study processes and patient and physiotherapist experiences of the new optimised intervention.
This study will determine the feasibility of a new optimised physiotherapy treatment package for people with tennis elbow and pilot the processes for a future fully powered RCT. In the longer term, this treatment package may provide superior clinical outcomes for patients, in terms of pain and quality of life, and be more cost-effective for the health service.
Registered with the ISRCTN database 19/7/2021, https://www.isrctn.com/ISRCTN64444585.
对于患有网球肘的人，推荐进行物理治疗，然而尽管有各种各样的治疗方法，但最佳治疗方案仍不确定。因此，我们最近基于证据综合、患者意见和临床共识，为网球肘开发了一种优化的物理治疗方案。它包括详细的建议和教育、结构化的渐进式锻炼计划以及提供反作用力肘部护具。在此，我们报告我们多中心试点和可行性随机对照试验（RCT）的方案，该试验旨在（a）检验我们优化的物理治疗方案的可行性，以及（b）为未来全面开展的RCT试点试验流程，以测试与常规物理治疗相比的临床效果和成本效益。
将在英格兰的三个地点进行多中心试点和可行性随机对照试验，招募最多50名患者（或为期最长12个月）。从物理治疗诊所候诊名单和全科诊所中识别出的网球肘患者将被随机分配接受优化的物理治疗方案或常规物理治疗护理。分析将集中在可行性指标上，包括同意率、干预保真度、随访率和结果完成率。一项嵌套的定性研究将探讨研究流程的可接受性以及患者和物理治疗师对新优化干预措施的体验。
本研究将确定针对网球肘患者的新优化物理治疗方案的可行性，并为未来全面开展的RCT试点试验流程。从长远来看，该治疗方案可能在疼痛和生活质量方面为患者提供更好的临床结果，并且对医疗服务来说更具成本效益。
于2021年7月19日在ISRCTN数据库注册，https://www.isrctn.com/ISRCTN64444585。
