Jones Gareth T, Mertens Kathrin, Macfarlane Gary J, Palmer Keith T, Coggon David, Walker-Bone Karen, Burton Kim, Heine Peter J, McCabe Candy, McNamee Paul, McConnachie Alex
Musculoskeletal Research Collaboration (Epidemiology Group), University of Aberdeen, Aberdeen, UK.
BMC Musculoskelet Disord. 2014 Mar 10;15:71. doi: 10.1186/1471-2474-15-71.
Distal upper limb pain (pain affecting the elbow, forearm, wrist, or hand) can be non-specific, or can arise from specific musculoskeletal disorders. It is clinically important and costly, the best approach to clinical management is unclear. Physiotherapy is the standard treatment and, while awaiting treatment, advice is often given to rest and avoid strenuous activities, but there is no evidence base to support these strategies. This paper describes the protocol of a randomised controlled trial to determine, among patients awaiting physiotherapy for distal arm pain, (a) whether advice to remain active and maintain usual activities results in a long-term reduction in arm pain and disability, compared with advice to rest; and (b) whether immediate physiotherapy results in a long-term reduction in arm pain and disability, compared with physiotherapy delivered after a seven week waiting list period.
METHODS/DESIGN: Between January 2012 and January 2014, new referrals to 14 out-patient physiotherapy departments were screened for potential eligibility. Eligible and consenting patients were randomly allocated to one of the following three groups in equal numbers: 1) advice to remain active, 2) advice to rest, 3) immediate physiotherapy. Patients were and followed up at 6, 13, and 26 weeks post-randomisation by self-complete postal questionnaire and, at six weeks, patients who had not received physiotherapy were offered it at this time. The primary outcome is the proportion of patients free of disability at 26 weeks, as determined by the modified DASH (Disabilities of the Arm, Shoulder and Hand) questionnaire.We hypothesise (a) that advice to maintain usual activities while awaiting physiotherapy will be superior than advice to rest the arm; and (b) that fast-track physiotherapy will be superior to normal (waiting list) physiotherapy. These hypotheses will be examined using an intention-to-treat analysis.
Results from this trial will contribute to the evidence base underpinning the clinical management of patients with distal upper limb pain, and in particular, will provide guidance on whether they should be advised to rest the arm or remain active within the limits imposed by their symptoms.
Registered on http://www.controlled-trials.com (reference number: ISRCTN79085082).
上肢远端疼痛(影响肘部、前臂、手腕或手部的疼痛)可能是非特异性的,也可能由特定的肌肉骨骼疾病引起。它在临床上很重要且成本高昂,目前尚不清楚最佳的临床管理方法。物理治疗是标准治疗方法,在等待治疗期间,通常会建议患者休息并避免剧烈活动,但没有证据支持这些策略。本文描述了一项随机对照试验的方案,以确定在等待物理治疗的上肢远端疼痛患者中,(a)与休息建议相比,保持活动并维持日常活动的建议是否能长期减轻手臂疼痛和残疾;(b)与经过七周等待期后进行的物理治疗相比,立即进行物理治疗是否能长期减轻手臂疼痛和残疾。
方法/设计:在2012年1月至2014年1月期间,对14个门诊物理治疗科室的新转诊患者进行潜在资格筛查。符合条件并同意参与的患者被等分为以下三组之一:1)保持活动的建议;2)休息的建议;3)立即进行物理治疗。在随机分组后的6周、13周和26周,通过自我填写邮寄问卷对患者进行随访,在6周时,未接受物理治疗的患者此时可接受治疗。主要结局是通过改良的DASH(上肢、肩部和手部功能障碍)问卷确定的26周时无残疾的患者比例。我们假设(a)在等待物理治疗期间保持日常活动的建议将优于让手臂休息的建议;(b)快速通道物理治疗将优于常规(等待名单)物理治疗。这些假设将使用意向性分析进行检验。
该试验的结果将有助于为上肢远端疼痛患者的临床管理提供证据基础,特别是将为是否应建议他们在症状限制范围内让手臂休息或保持活动提供指导。