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一项针对慢性颈痛综合运动方案的随机临床试验:试验方案。

A randomised clinical trial of a comprehensive exercise program for chronic whiplash: trial protocol.

机构信息

The George Institute for International Health, The University of Sydney, George Street, Sydney, 2000, Australia.

出版信息

BMC Musculoskelet Disord. 2009 Dec 2;10:149. doi: 10.1186/1471-2474-10-149.

Abstract

BACKGROUND

Whiplash is the most common injury following a motor vehicle accident. Approximately 60% of people suffer persistent pain and disability six months post injury. Two forms of exercise; specific motor relearning exercises and graded activity, have been found to be effective treatments for this condition. Although the effect sizes for these exercise programs, individually, are modest, pilot data suggest much larger effects on pain and disability are achieved when these two treatments are combined. The aim of this study is to investigate the effectiveness and cost-effectiveness of this comprehensive exercise approach for chronic whiplash.

METHODS/DESIGN: A multicentre randomised controlled trial will be conducted. One hundred and seventy-six participants with chronic grade I to II whiplash will be recruited in Sydney and Brisbane, Australia. All participants will receive an educational booklet on whiplash and in addition, those randomised to the comprehensive exercise group (specific motor relearning and graded activity exercises) will receive 20 progressive and individually-tailored, 1 hour exercise sessions over a 12 week period (specific motor relearning exercises: 8 sessions over 4 weeks; graded activity: 12 sessions over 8 weeks). The primary outcome to be assessed is pain intensity. Other outcomes of interest include disability, health-related quality of life and health service utilisation. Outcomes will be measured at baseline, 14 weeks, 6 months and 12 months by an assessor who is blinded to the group allocation of the subjects. Recruitment is due to commence in late 2009.

DISCUSSION

The successful completion of this trial will provide evidence on the effectiveness and cost-effectiveness of a simple treatment for the management of chronic whiplash.

TRIAL REGISTRATION

ACTRN12609000825257.

摘要

背景

挥鞭伤是机动车事故后最常见的损伤。大约 60%的人在受伤后 6 个月仍有持续性疼痛和残疾。已经发现两种运动形式,即特定的运动再学习运动和分级活动,对这种情况有效。尽管这些运动方案的效应大小,单独来看,适中,但初步数据表明,当这两种治疗方法结合使用时,对疼痛和残疾的效果更大。本研究的目的是研究这种综合运动方法对慢性挥鞭伤的有效性和成本效益。

方法/设计:将进行一项多中心随机对照试验。将在澳大利亚悉尼和布里斯班招募 176 名慢性 I 级至 II 级挥鞭伤患者。所有参与者都将收到一本关于挥鞭伤的教育手册,此外,那些随机分配到综合运动组(特定的运动再学习和分级活动运动)的人将在 12 周内接受 20 次渐进和个体化的 1 小时运动课程(特定的运动再学习运动:4 周内 8 次;分级活动:8 周内 12 次)。将评估的主要结果是疼痛强度。其他感兴趣的结果包括残疾、健康相关生活质量和卫生服务利用。通过一位对受试者分组不知情的评估者,在基线、14 周、6 个月和 12 个月时测量结果。招募工作预计将于 2009 年末开始。

讨论

成功完成这项试验将为慢性挥鞭伤管理的简单治疗的有效性和成本效益提供证据。

试验注册

ACTRN12609000825257。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ff6a/2799382/0c93a2cbf341/1471-2474-10-149-1.jpg

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