针刺作为急诊科腰痛、踝关节扭伤和偏头痛的镇痛方法：一项随机对照试验的研究方案。
Acupuncture as analgesia for low back pain, ankle sprain and migraine in emergency departments: study protocol for a randomized controlled trial.
机构信息
RMIT University Australia PO Box 71 Bundoora, Victoria 3083 Australia.
出版信息
Trials. 2011 Nov 15;12:241. doi: 10.1186/1745-6215-12-241.
BACKGROUND
Pain is the most common reason that patients present to an emergency department (ED) and is often inadequately managed. Evidence suggests that acupuncture is effective for pain relief, yet it is rarely practiced in the ED. The current study aims to assess the efficacy of acupuncture for providing effective analgesia to patients presenting with acute low back pain, migraine and ankle sprain at the EDs of four hospitals in Melbourne, Australia.
METHOD
The study is a multi-site, randomized, assessor-blinded, controlled trial of acupuncture analgesia in patients who present to an ED with low back pain, migraine or ankle sprain. Patients will be block randomized to receive either acupuncture alone, acupuncture as an adjunct to pharmacotherapy or pharmacotherapy alone. Acupuncture will be applied according to Standards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA). Pain after one hour, measured using a visual analogue scale (VAS), is the primary outcome. Secondary outcomes measures include the following instruments; the Oswestry low back pain disability questionnaire, 24-hour Migraine Quality of Life questionnaire and Patient's Global Assessment of Ankle Injury Scale. These measures will be recorded at baseline, 1 hour after intervention, each hour until discharge and 48±12 hours of ED discharge. Data will also be collected on the safety and acceptability of acupuncture and health resource utilization.
DISCUSSION
The results of this study will determine if acupuncture, alone or as an adjunct to pharmacotherapy provides effective, safe and acceptable pain relief for patients presenting to EDs with acute back pain, migraine or ankle sprain. The results will also identify the impact that acupuncture treatment may have upon health resource utilisation in the ED setting.
TRIAL REGISTRATION
Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12609000989246.
背景
疼痛是患者前往急诊部（ED）就诊的最常见原因，且往往得不到充分治疗。有证据表明，针刺对于缓解疼痛是有效的，但在 ED 中却很少使用。本研究旨在评估针刺治疗在缓解急性腰痛、偏头痛和踝关节扭伤患者疼痛方面的疗效，该研究在澳大利亚墨尔本的 4 家医院的 ED 进行。
方法
这是一项多地点、随机、评估者设盲、对照的针刺镇痛研究，研究对象为 ED 就诊的腰痛、偏头痛或踝关节扭伤患者。患者将被随机分组，接受单纯针刺、针刺联合药物治疗或单纯药物治疗。针刺将按照针刺临床试验报告标准（STRICTA）进行。1 小时后使用视觉模拟评分（VAS）测量疼痛程度，作为主要结局。次要结局指标包括以下内容：Oswestry 腰痛残疾问卷、24 小时偏头痛生活质量问卷和患者踝关节损伤整体评估量表。这些指标将在基线、干预后 1 小时、直至出院的每个小时以及 ED 出院后 48±12 小时进行记录。还将收集针刺的安全性和可接受性以及卫生资源利用的数据。
讨论
该研究的结果将确定单独使用针刺或作为药物治疗的辅助手段是否能为 ED 就诊的急性背痛、偏头痛或踝关节扭伤患者提供有效、安全和可接受的疼痛缓解。研究结果还将确定针刺治疗可能对 ED 环境中卫生资源利用的影响。
试验注册
澳大利亚和新西兰临床试验注册（ANZCTR）：ACTRN12609000989246。
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