Lim Yuan Z, Urquhart Donna M, Wang Yuanyuan, Estee Mahnuma Mahfuz, Wluka Anita E, Heritier Stephane, Cicuttini Flavia M
School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, 3004, Australia.
Osteoarthr Cartil Open. 2024 May 14;7(1):100486. doi: 10.1016/j.ocarto.2024.100486. eCollection 2025 Mar.
Chronic low back pain is a major cause of pain and disability with limited effective therapies. Metformin is a safe, inexpensive, well-tolerated drug that has pleotropic effects, including effects on pain pathways that may influence low back pain. The aim of this randomised, double-blind, placebo-controlled trial is to determine whether metformin reduces low back pain over 4 months in individuals with chronic low back pain.
One hundred and twenty-three participants with chronic low back pain will be recruited from the community in Melbourne, Australia, and randomly allocated in a 1:1 ratio to receive either metformin 2g or identical placebo daily for 4 months. The primary outcome will be change in pain intensity assessed using a 100 mm visual analogue scale at 4 months and the secondary outcomes will be change in low back disability, physical activity and narcotic use. Adverse events will be recorded. The primary analysis will be by intention to treat.
Given the societal burden of LBP and the limited effective treatment options available, this study that evaluates the efficacy of metformin in LBP, if proves to be effective, will offer an important therapeutic approach for this disabling condition.
Ethics approval has been obtained from the Alfred Hospital Ethics Committee (392/21) and Monash University Human Research Ethics Committee (30607). Written informed consent will be obtained from all the participants. The findings will be disseminated through peer-review publications and conference presentations.
Australian New Zealand Clinical Trials Registry, ACTRN12621001453875 (registered 25th October 2021).
慢性下腰痛是疼痛和残疾的主要原因，有效治疗方法有限。二甲双胍是一种安全、廉价且耐受性良好的药物，具有多种有益作用，包括对可能影响下腰痛的疼痛通路的作用。这项随机、双盲、安慰剂对照试验的目的是确定二甲双胍是否能在4个月内减轻慢性下腰痛患者的下腰痛。
将从澳大利亚墨尔本的社区招募123名慢性下腰痛患者，并以1:1的比例随机分配，使其每天接受2克二甲双胍或相同的安慰剂，为期4个月。主要结局将是在4个月时使用100毫米视觉模拟量表评估的疼痛强度变化，次要结局将是下腰痛残疾、身体活动和麻醉药物使用的变化。将记录不良事件。主要分析将按意向性分析进行。
鉴于下腰痛的社会负担以及可用的有效治疗选择有限，本研究评估二甲双胍在下腰痛中的疗效，如果证明有效，将为这种致残性疾病提供一种重要的治疗方法。
已获得阿尔弗雷德医院伦理委员会（392/21）和莫纳什大学人类研究伦理委员会（30607）的伦理批准。将获得所有参与者的书面知情同意。研究结果将通过同行评审出版物和会议报告进行传播。
澳大利亚新西兰临床试验注册中心，ACTRN12621001453875（2021年10月25日注册）。
