Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Alfred Hospital, Melbourne, VIC, 3004, Australia.
Department of Neurosurgery, Alfred Hospital, Melbourne, VIC, 3004, Australia.
Trials. 2021 Oct 30;22(1):759. doi: 10.1186/s13063-021-05728-1.
There has been immense interest and debate regarding the effectiveness of antibiotic treatment for chronic low back pain. Two randomised controlled trials have examined the efficacy of antibiotics for chronic low back pain with disc herniation and Modic changes, but have reported conflicting results. The aim of this double-blind, randomised, placebo-controlled trial is to determine the efficacy of antibiotic treatment in a broader patient subgroup of chronic low back pain with disc herniation and investigate whether the presence of Modic changes predicts response to antibiotic therapy.
One hundred and seventy individuals with chronic low back pain will be recruited through hospital and private medical and allied health clinics; advertising in national, community and social media; and posting of flyers in community locations. They will be randomly allocated to receive either amoxicillin-clavulanate (500 mg/125 mg) twice per day for 90 days or placebo. The primary outcome measure of pain intensity will be assessed using the Low Back Pain Rating scale and a 100-mm visual analogue scale at 12 months. Secondary measures of self-reported low back disability and work absence and hindrance will also be examined, and an economic analysis will be conducted. Intention-to-treat analyses will be performed.
There is uncertainty about whether antibiotic treatment is effective for chronic low back pain and, if effective, which patient subgroup is most likely to respond. We will conduct a clinical trial to investigate the efficacy of antibiotics compared with placebo in individuals with chronic low back pain and a disc herniation. Our findings will provide high-quality evidence to assist in answering these questions.
Australian New Zealand Clinical Trials Registry ACTRN12615000958583 . Registered on 11 September 2015.
抗生素治疗慢性下腰痛的有效性引起了广泛关注和争议。两项随机对照试验已经研究了抗生素治疗椎间盘突出和 Modic 改变的慢性下腰痛的疗效，但报告的结果相互矛盾。本双盲、随机、安慰剂对照试验的目的是确定抗生素治疗更广泛的慢性下腰痛伴椎间盘突出患者亚组的疗效，并研究 Modic 改变的存在是否预测抗生素治疗的反应。
通过医院和私人医疗及联合健康诊所、全国性、社区和社交媒体的广告以及在社区场所张贴传单，共招募了 170 名慢性下腰痛患者。他们将被随机分配接受阿莫西林克拉维酸钾（500 mg/125 mg）每日两次，持续 90 天，或安慰剂。主要结局测量疼痛强度将使用下腰痛评定量表和 100 毫米视觉模拟量表在 12 个月时进行评估。还将检查自我报告的下腰痛残疾和缺勤及妨碍的次要测量指标，并进行经济分析。将进行意向治疗分析。
对于慢性下腰痛，抗生素治疗是否有效，以及如果有效，哪些患者亚组最有可能反应，仍存在不确定性。我们将进行一项临床试验，以研究抗生素与安慰剂相比在慢性下腰痛伴椎间盘突出患者中的疗效。我们的研究结果将提供高质量的证据，以帮助回答这些问题。
澳大利亚新西兰临床试验注册 ACTRN12615000958583 。于 2015 年 9 月 11 日注册。
