Hutton Joshua M, Gamble Andrew R, Maher Chris G, de Campos Tarcisio F, Han Christopher S, Coombs Danielle, Halliday Mark, Harvey Lisa A, Foster Nadine E, Machado Gustavo, Anderson David, Billot Laurent, Richards Bethan, Swain Michael, McKay Marnee, Needs Chris, Chu Jackie, Shaw Timothy, Lung Tom, Harris Ian A, Zadro Joshua R
Institute for Musculoskeletal Health, Sydney Local Health District, Sydney, New South Wales, Australia
Sydney School of Public Health, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia.
BMJ Open. 2025 Jan 15;15(1):e091293. doi: 10.1136/bmjopen-2024-091293.
Musculoskeletal pain is the second leading cause of disease burden in Australia, and there is a need to investigate new models of care to cope with the increasing demand for health services. This paper describes the protocol for a randomised controlled trial investigating whether a physiotherapist-led triage and treatment service is non-inferior for improving function at 6 months and superior for reducing treatment waiting times, compared with usual care for patients with musculoskeletal pain referred to public hospital outpatient physiotherapy clinics.
A total of 368 participants (184 per arm) will be recruited from six public hospitals located in metropolitan Sydney, Australia. We will recruit adult patients newly referred to a public hospital physiotherapy outpatient clinic with a musculoskeletal condition that is typically managed by a physiotherapist (eg, back or neck pain, osteoarthritis, rehabilitation postorthopaedic surgery and sporting injuries). Participants will be randomised 1:1 to the physiotherapist-led triage and treatment service or usual care. A physiotherapist will telephone participants in the intervention group and match them to different modes and types of care based on baseline characteristics. Participants at low risk of poor outcomes (assessed by the Keele STarT MSK tool) will be given simple advice and education during this call and instructed to call back if their symptoms do not improve in 6 weeks. Participants at medium risk of poor outcomes or requiring postoperative rehabilitation will be offered a course of telehealth (videoconference) physiotherapy targeting exercise-based self-management. Participants at high risk of poor outcomes and/or with potential nonprogressive radiculopathy will be offered a course of usual clinic-based physiotherapy as per all participants in the usual care group. Physical function (Patient Specific Functional Scale) at 6 months postrandomisation and waiting time (time from randomisation to first treatment) are coprimary outcomes. Secondary outcomes include other patient outcomes (eg, pain), health resource use, adverse events, process measures (eg, adherence) and costs.
This trial has approval from the Sydney Local Health District Human Research Ethics Committee (RPAH Zone; X24-0090 and 2024/ETH00585). Recruitment will commence in September 2024 and is expected to be completed by December 2025 with follow-ups completed by December 2026. The results of the trial will be submitted for publication in reputable international journals and presented at relevant national and international conferences.
ANZCTR (ACTRN12624000947505).
肌肉骨骼疼痛是澳大利亚疾病负担的第二大主要原因,因此有必要研究新的护理模式,以应对对医疗服务日益增长的需求。本文描述了一项随机对照试验的方案,该试验旨在研究与转介到公立医院门诊物理治疗诊所的肌肉骨骼疼痛患者接受的常规护理相比,由物理治疗师主导的分诊和治疗服务在改善6个月时的功能方面是否不劣于常规护理,以及在减少治疗等待时间方面是否优于常规护理。
将从澳大利亚悉尼大都市地区的六家公立医院招募总共368名参与者(每组184名)。我们将招募新转介到公立医院物理治疗门诊诊所的成年患者,他们患有通常由物理治疗师管理的肌肉骨骼疾病(例如背痛或颈痛、骨关节炎、骨科手术后康复和运动损伤)。参与者将按1:1随机分配到由物理治疗师主导的分诊和治疗服务组或常规护理组。物理治疗师将给干预组的参与者打电话,并根据基线特征为他们匹配不同的护理模式和类型。预后不良风险较低的参与者(通过基尔STAR-T MSK工具评估)将在此次电话中获得简单的建议和教育,并被告知如果症状在6周内没有改善就回电。预后不良风险中等或需要术后康复的参与者将获得一个以运动为基础的自我管理为目标的远程医疗(视频会议)物理治疗课程。预后不良风险高和/或有潜在非进行性神经根病的参与者将按照常规护理组的所有参与者那样接受一个基于门诊的常规物理治疗课程。随机分组后6个月时的身体功能(患者特定功能量表)和等待时间(从随机分组到首次治疗的时间)是共同主要结局。次要结局包括其他患者结局(例如疼痛)、卫生资源利用、不良事件、过程指标(例如依从性)和成本。
本试验已获得悉尼地方卫生区人类研究伦理委员会(皇家阿尔弗雷德王子医院区;X24-0090和2024/ETH00585)的批准。招募将于2024年9月开始,预计于2025年12月完成,随访于2026年12月完成。试验结果将提交至著名国际期刊发表,并在相关的国家和国际会议上展示。
澳大利亚和新西兰临床试验注册中心(ACTRN12624000947505)