Littlewood Chris, Wade Julia, Butler-Walley Stephanie, Lewis Martyn, Beard David, Rangan Amar, Bhabra Gev, Kalogrianitis Socrates, Kelly Cormac, Mehta Saurabh, Singh Harvinder Pal, Smith Matthew, Tambe Amol, Tyler James, Foster Nadine E
School of Primary, Community and Social Care, Keele University, Staffordshire, UK.
Department of Health Professions, Faculty of Health, Psychology & Social Care, Manchester Metropolitan University, Manchester, UK.
Pilot Feasibility Stud. 2021 Jan 7;7(1):17. doi: 10.1186/s40814-020-00714-x.
Clinically, a distinction is made between types of rotator cuff tear, traumatic and non-traumatic, and this sub-classification currently informs the treatment pathway. It is currently recommended that patients with traumatic rotator cuff tears are fast tracked for surgical opinion. However, there is uncertainty about the most clinically and cost-effective intervention for patients with traumatic rotator cuff tears and further research is required. SPeEDy will assess the feasibility of a fully powered, multi-centre randomised controlled trial (RCT) to test the hypothesis that, compared to surgical repair (and usual post-operative rehabilitation), a programme of physiotherapist-led exercise is not clinically inferior, but is more cost-effective for patients with traumatic rotator cuff tears.
SPeEDy is a two-arm, multi-centre pilot and feasibility RCT with integrated Quintet Recruitment Intervention (QRI) and further qualitative investigation of patient experience. A total of 76 patients with traumatic rotator cuff tears will be recruited from approximately eight UK NHS hospitals and randomly allocated to either surgical repair and usual post-operative rehabilitation or a programme of physiotherapist-led exercise. The QRI is a mixed-methods approach that includes data collection and analysis of screening logs, audio recordings of recruitment consultations, interviews with patients and clinicians involved in recruitment, and review of study documentation as a basis for developing action plans to address identified difficulties whilst recruitment to the RCT is underway. A further sample of patient participants will be purposively sampled from both intervention groups and interviewed to explore reasons for initial participation, treatment acceptability, reasons for non-completion of treatment, where relevant, and any reasons for treatment crossover.
Research to date suggests that there is uncertainty regarding the most clinically and cost-effective interventions for patients with traumatic rotator cuff tears. There is a clear need for a high-quality, fully powered, RCT to better inform clinical practice. Prior to this, we first need to undertake a pilot and feasibility RCT to address current uncertainties about recruitment, retention and number of and reasons for treatment crossover.
ClinicalTrials.gov ( NCT04027205 ) - Registered on 19 July 2019. Available via.
临床上，肩袖撕裂分为创伤性和非创伤性两种类型，这种亚分类目前为治疗路径提供依据。目前建议创伤性肩袖撕裂患者尽快寻求手术意见。然而，对于创伤性肩袖撕裂患者最具临床疗效和成本效益的干预措施尚不确定，需要进一步研究。SPeEDy研究将评估一项全规模、多中心随机对照试验（RCT）的可行性，以检验以下假设：与手术修复（及常规术后康复）相比，由物理治疗师主导的运动方案在临床上并不逊色，且对创伤性肩袖撕裂患者更具成本效益。
SPeEDy是一项双臂、多中心的试点和可行性随机对照试验，采用综合的五重招募干预措施（QRI），并对患者体验进行进一步的定性调查。将从大约八家英国国民健康服务体系（NHS）医院招募76例创伤性肩袖撕裂患者，并随机分配至手术修复及常规术后康复组或由物理治疗师主导的运动方案组。QRI是一种混合方法，包括收集和分析筛查记录、招募咨询的音频记录、对参与招募的患者和临床医生进行访谈，以及审查研究文档，以此作为制定行动计划的基础，以便在RCT招募过程中解决已发现的困难。将从两个干预组中有目的地抽取更多患者样本进行访谈，以探究初始参与的原因、治疗的可接受性、未完成治疗的原因（如相关）以及治疗交叉的任何原因。
迄今为止的研究表明，对于创伤性肩袖撕裂患者最具临床疗效和成本效益的干预措施尚不确定。显然需要进行一项高质量、全规模的随机对照试验，以便为临床实践提供更好的依据。在此之前，我们首先需要开展一项试点和可行性随机对照试验，以解决目前在招募、留存、治疗交叉的数量及原因方面存在的不确定性。
ClinicalTrials.gov（NCT04027205）- 于2019年7月19日注册。可通过……获取。
