University Hospitals of Derby & Burton NHS Foundation Trust, Derby, UK; School of Medicine, Keele University, UK.
Derby Clinical Trials Support Unit, Derby, UK.
Musculoskelet Sci Pract. 2024 Feb;69:102905. doi: 10.1016/j.msksp.2023.102905. Epub 2023 Dec 30.
BACKGROUND: The OPTimisE intervention was developed to address uncertainty regarding the most effective physiotherapy treatment strategy for people with Lateral Elbow Tendinopathy (LET). OBJECTIVES: To assess the feasibility of conducting a fully-powered randomised controlled trial (RCT) evaluating whether the OPTimisE intervention is superior to usual physiotherapy treatment for adults with LET. DESIGN: A mixed-methods multi-centred, parallel pilot and feasibility RCT, conducted in three outpatient physiotherapy departments in the UK. METHOD: Patients were independently randomised 1:1 in mixed blocks, stratified by site, to the OPTimisE intervention or usual care. Outcomes were assessed using pre-defined feasibility progression criteria. RESULTS: 50 patients were randomised (22 Female, 28 Male), mean age 48 years (range 27-75). Consent rate was 71% (50/70), fidelity to intervention 89% (16/18), attendance rate in the OPTimisE group 82% (55/67) vs 85% (56/66) in usual care, outcome measure completion 81% (39/48) at six-month follow-up. There were no related adverse events. Patients and physiotherapists reported that the OPTimisE intervention was acceptable but suggested improvements to the trial design. 49 patients were recruited from physiotherapy referrals vs one from primary care records. Outcome measure return rates were higher when completed online (74%) compared to postal questionnaire (50%). Exploratory analysis showed improvements in both groups over time. CONCLUSIONS: It is methodologically feasible to conduct a fully powered RCT comparing the clinical and cost-effectiveness of the OPTimisE intervention versus usual physiotherapy treatment. Considering the similar improvements observed in both groups, careful consideration is needed regarding the priority research question to be addressed in future research.
背景:OPTimisE 干预措施是为了解决人们对治疗外侧肘肌腱病(LET)的最有效物理治疗策略的不确定性而开发的。
目的:评估进行一项充分-powered 的随机对照试验(RCT)的可行性,评估 OPTimisE 干预措施是否优于 LET 成人的常规物理治疗。
设计:一项在英国三个门诊物理治疗部门进行的混合方法多中心、平行先导和可行性 RCT。
方法:患者以 1:1 的比例在混合块中独立随机分组,按地点分层为 OPTimisE 干预组或常规护理组。使用预先定义的可行性进展标准评估结果。
结果:50 名患者被随机分配(22 名女性,28 名男性),平均年龄 48 岁(范围 27-75 岁)。同意率为 71%(50/70),对干预措施的一致性为 89%(16/18),OPTimisE 组的出勤率为 82%(55/67),常规护理组为 85%(56/66),6 个月随访时完成结局测量的比例为 81%(39/48)。没有相关的不良事件。患者和物理治疗师报告称 OPTimisE 干预措施是可以接受的,但建议改进试验设计。从物理治疗转诊中招募了 49 名患者,而从初级保健记录中招募了 1 名患者。在线完成的结局测量回收率为 74%,高于邮寄问卷的 50%。探索性分析显示两组随时间均有改善。
结论:比较 OPTimisE 干预措施与常规物理治疗的临床和成本效益是在方法学上可行的。考虑到两组观察到的相似改善,需要仔细考虑未来研究中需要解决的优先研究问题。
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