Urquhart Donna M, Wluka Anita E, Sim Malcolm R, van Tulder Maurits, Forbes Andrew, Gibson Stephen J, Arnold Carolyn, Fong Chris, Anthony Shane N, Cicuttini Flavia M
Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Alfred Hospital, Melbourne, VIC, 3004, Australia.
Department of Health Sciences and EMGO+, Institute for Health and Care Research, VU University, 1081 HV, Amsterdam, The Netherlands.
Trials. 2016 Oct 22;17(1):514. doi: 10.1186/s13063-016-1637-1.
Low back pain is a major clinical and public health problem, with limited evidence-based treatments. Low-dose antidepressants are commonly used to treat pain in chronic low back pain. However, their efficacy is unproven. The aim of this pragmatic, double-blind, randomised, placebo-controlled trial is to determine whether low-dose amitriptyline (an antidepressant) is more effective than placebo in reducing pain in individuals with chronic low back pain.
METHODS/DESIGN: One hundred and fifty individuals with chronic low back pain will be recruited through hospital and private medical and allied health clinics, advertising in local media and posting of flyers in community locations. They will be randomly allocated to receive either low-dose amitriptyline (25 mg) or an active placebo (benztropine mesylate, 1 mg) for 6 months. The primary outcome measure of pain intensity will be assessed at baseline, 3 and 6 months using validated questionnaires. Secondary measures of self-reported low back disability, work absence and hindrance in the performance of paid/unpaid work will also be examined. Intention-to-treat analyses will be performed.
This pragmatic, double-blind, randomised, placebo-controlled trial will provide evidence regarding the effectiveness of low-dose antidepressants compared with placebo in reducing pain, disability, work absenteeism and hindrance in work performance in individuals with chronic low back pain. This trial has major public health and clinical importance as it has the potential to provide an effective approach to the management of chronic low back pain.
Australian New Zealand Clinical Trials Registry: ACTRN12612000131853 ; registered on 30 January 2012.
腰痛是一个主要的临床和公共卫生问题，基于证据的治疗方法有限。低剂量抗抑郁药常用于治疗慢性腰痛。然而，其疗效尚未得到证实。这项务实、双盲、随机、安慰剂对照试验的目的是确定低剂量阿米替林（一种抗抑郁药）在减轻慢性腰痛患者疼痛方面是否比安慰剂更有效。
方法/设计：将通过医院、私人医疗及相关健康诊所、在当地媒体上做广告以及在社区地点张贴传单等方式招募150名慢性腰痛患者。他们将被随机分配接受低剂量阿米替林（25毫克）或活性安慰剂（甲磺酸苯扎托品，1毫克）治疗6个月。使用经过验证的问卷在基线、3个月和6个月时评估疼痛强度的主要结局指标。还将检查自我报告的腰痛残疾、缺勤以及对有偿/无偿工作表现的阻碍等次要指标。将进行意向性分析。
这项务实、双盲、随机、安慰剂对照试验将提供证据，说明与安慰剂相比，低剂量抗抑郁药在减轻慢性腰痛患者的疼痛、残疾、旷工以及工作表现阻碍方面的有效性。该试验具有重大的公共卫生和临床意义，因为它有可能为慢性腰痛的管理提供一种有效的方法。
澳大利亚新西兰临床试验注册中心：ACTRN12 — 612 — 000131853；于2012年1月30日注册。
