Kolling Institute, The University of Sydney, Sydney, New South Wales, Australia.
Kolling Institute, Northern Sydney Local Health District, Sydney, New South Wales, Australia.
BMJ Open. 2021 May 18;11(5):e041242. doi: 10.1136/bmjopen-2020-041242.
Exercise, support and advice are considered core components of management for most musculoskeletal conditions and are typically provided by physiotherapists through regular face-to-face treatments. However, exercise can be provided remotely as part of a home exercise programme, while support and advice can be provided over the telephone. There is initial evidence from trials and systematic reviews to suggest that remotely provided physiotherapy can be used to manage a variety of musculoskeletal conditions safely and effectively.
The aim of this single-blind randomised controlled non-inferiority trial is to determine whether a supported home exercise programme is as good as or better than face-to-face physiotherapy for the treatment of musculoskeletal conditions. Two hundred and ten participants will be recruited from five public hospitals in Sydney, Australia. Participants will be randomised to either the supported home exercise group or the face-to-face physiotherapy group. Participants allocated to the supported home exercise group will initially receive one face-to-face session with the trial physiotherapist and will then be managed remotely for the next 6 weeks. Participants allocated to the face-to-face physiotherapy group will receive a course of physiotherapy as typically provided in Sydney government hospitals. The primary outcome is function measured by the Patient Specific Functional Scale at 6 weeks. There will be nine secondary outcomes measured at 6 and 26 weeks. Separate analyses will be conducted on each outcome, and all analyses will be conducted on an intention-to-treat basis. A health economic evaluation will be conducted from a health funder plus patient perspective.
Ethical approval was obtained on the 17 March 2017 from the Northern Sydney Local Health District HREC, trial number HREC/16HAWKE/431-RESP/16/287. The results of this study will be submitted for publication to peer-reviewed journals and be presented at national and international conferences. Recruitment commenced in March 2019, and it is anticipated that the trial will be completed by December 2021. This trial will investigate two different models of physiotherapy care for people with musculoskeletal conditions.
CPMP/ICH-135/95.
The most recent version of the protocol is V.1.2 dated November 2019.
运动、支持和建议被认为是大多数肌肉骨骼疾病管理的核心组成部分，通常由物理治疗师通过定期的面对面治疗提供。然而，运动可以作为家庭运动计划的一部分远程提供，而支持和建议可以通过电话提供。有初步的试验和系统评价证据表明，远程提供的物理治疗可以安全有效地用于管理各种肌肉骨骼疾病。
本单盲随机对照非劣效性试验的目的是确定支持性家庭运动计划是否与面对面物理治疗一样或更好地治疗肌肉骨骼疾病。将从澳大利亚悉尼的五家公立医院招募 210 名参与者。参与者将被随机分配到支持性家庭运动组或面对面物理治疗组。分配到支持性家庭运动组的参与者将首先与试验物理治疗师进行一次面对面的治疗，然后在接下来的 6 周内进行远程管理。分配到面对面物理治疗组的参与者将接受悉尼政府医院通常提供的一疗程物理治疗。主要结局是 6 周时用患者特定功能量表测量的功能。在 6 周和 26 周时将有 9 个次要结局进行测量。将对每个结局进行单独分析，所有分析都将基于意向治疗进行。将从健康基金和患者角度进行健康经济学评估。
2017 年 3 月 17 日，该研究获得了北悉尼地方卫生区 HREC 的伦理批准，试验编号为 HREC/16HAWKE/431-RESP/16/287。这项研究的结果将提交给同行评议的期刊发表，并在国家和国际会议上报告。招募于 2019 年 3 月开始，预计试验将于 2021 年 12 月完成。这项试验将研究肌肉骨骼疾病患者两种不同的物理治疗护理模式。
CPMP/ICH-135/95。
最新版本的方案是 2019 年 11 月的 V.1.2 版。
