University of Warwick, Clinical Trials Unit, Gibbet Hill Road, Coventry, CV4 7AL, United Kingdom.
Manchester Metropolitan University, Manchester, M15 6BH, United Kingdom.
Physiotherapy. 2021 Dec;113:80-87. doi: 10.1016/j.physio.2021.06.002. Epub 2021 Jun 17.
Optimum physiotherapy management for people with a conservatively managed primary traumatic anterior shoulder dislocation is not known. The purpose of the ARTISAN trial is to compare the clinical and cost-effectiveness of a course of usual care physiotherapy with a single session of physiotherapy and self-management, the ARTISAN intervention. ARTISAN is a UK multi-centre, two-arm, parallel group, randomised controlled trial with 1:1 treatment allocation.
The intervention was developed following the Medical Research Council framework for developing and evaluating complex interventions and will be reported in line with the template for intervention description and replication checklist (TIDieR) and the Consensus on Exercise Reporting Template (CERT). It was informed by published research, national clinical guidelines, current clinical practice and patient and public involvement.
The ARTISAN intervention comprises education (Phase 1), progressive exercise (Phase 2 and Phase 3) and an optional return to sport component (Phase 4). Behaviour change strategies are embedded throughout intervention. The single session of physiotherapy is delivered by a chartered physiotherapist, within the first six weeks of injury, in an NHS outpatient setting. At the end of the initial session, paper-based booklets and/or a patient website with the same content are provided to participants to aid self-management and progression though the four phases of the trial intervention.
The ARTISAN intervention was successfully implemented throughout the internal pilot and is suitable for testing in the subsequent definitive RCT ARTISAN trial. Trial Registration Number ISRCTN63184243.
对于接受保守治疗的原发性创伤性前肩脱位患者,最佳的物理治疗管理方法尚不清楚。ARTISAN 试验的目的是比较常规护理物理治疗疗程与单次物理治疗和自我管理(ARTISAN 干预)的临床和成本效益。ARTISAN 是一项英国多中心、双臂、平行组、随机对照试验,治疗分配为 1:1。
干预措施是根据医学研究委员会制定和评估复杂干预措施的框架制定的,并将按照干预描述和复制清单(TIDieR)模板以及共识运动报告模板(CERT)进行报告。它是基于已发表的研究、国家临床指南、当前的临床实践以及患者和公众的参与情况。
ARTISAN 干预措施包括教育(第 1 阶段)、渐进性运动(第 2 阶段和第 3 阶段)和可选的重返运动部分(第 4 阶段)。行为改变策略贯穿整个干预过程。单次物理治疗由持牌物理治疗师在受伤后的前六周内,在 NHS 门诊环境中提供。在初始治疗结束时,将提供纸质小册子和/或具有相同内容的患者网站,以帮助参与者进行自我管理并逐步完成试验干预的四个阶段。
ARTISAN 干预措施在内部试点研究中成功实施,适合在随后的 ARTISAN 试验的确定性 RCT 中进行测试。试验注册号 ISRCTN63184243。