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Abstract：
BACKGROUND: Bacterial infection and Modic changes (MCs) as causes of low back pain (LBP) are debated. Results diverged between two randomised controlled trials examining the effect of amoxicillin with and without clavulanic acid versus placebo on patients with chronic LBP (cLBP) and MCs. Previous biopsy studies have been criticised with regard to methods, few patients and controls, and insufficient measures to minimise perioperative contamination. In this study, we minimise contamination risk, include a control group and optimise statistical power. The main aim is to compare bacterial growth between patients with and without MCs.
METHODS: This multicentre, case-control study examines disc and vertebral body biopsies of patients with cLBP. Cases have MCs at the level of tissue sampling, controls do not. Previously operated patients are included as a subgroup. Tissue is sampled before antibiotic prophylaxis with separate instruments. We will apply microbiological methods and histology on biopsies, and predefine criteria for significant bacterial growth, possible contamination and no growth. Microbiologists, surgeons and pathologist are blinded to allocation of case or control. Primary analysis assesses significant growth in MC1 versus controls and MC2 versus controls separately. Bacterial disc growth in previously operated patients, patients with large MCs and growth from the vertebral body in the fusion group are all considered exploratory analyses.
BACKGROUND: The Regional Committees for Medical and Health Research Ethics in Norway (REC South East, reference number 2015/697) has approved the study. Study participation requires written informed consent. The study is registered at ClinicalTrials.gov (NCT03406624). Results will be disseminated in peer-reviewed journals, scientific conferences and patient fora.
BACKGROUND: NCT03406624.
METHODS: This multicentre, case-control study examines disc and vertebral body biopsies of patients with cLBP. Cases have MCs at the level of tissue sampling, controls do not. Previously operated patients are included as a subgroup. Tissue is sampled before antibiotic prophylaxis with separate instruments. We will apply microbiological methods and histology on biopsies, and predefine criteria for significant bacterial growth, possible contamination and no growth. Microbiologists, surgeons and pathologist are blinded to allocation of case or control. Primary analysis assesses significant growth in MC1 versus controls and MC2 versus controls separately. Bacterial disc growth in previously operated patients, patients with large MCs and growth from the vertebral body in the fusion group are all considered exploratory analyses.
BACKGROUND: The Regional Committees for Medical and Health Research Ethics in Norway (REC South East, reference number 2015/697) has approved the study. Study participation requires written informed consent. The study is registered at ClinicalTrials.gov (NCT03406624). Results will be disseminated in peer-reviewed journals, scientific conferences and patient fora.
BACKGROUND: NCT03406624.
摘要：
背景：作为下腰痛（LBP）原因的细菌感染和Modic变化（MC）存在争议。两项随机对照试验的结果不同，该试验研究了含和不含克拉维酸的阿莫西林与安慰剂对慢性LBP（cLBP）和MC患者的影响。以前的活检研究在方法上受到批评，很少有病人和对照组，和措施不足以减少围手术期污染。在这项研究中,我们将污染风险降至最低，包括一个控制组，并优化统计能力。主要目的是比较有和没有MC的患者之间的细菌生长。
方法：这个多中心，病例对照研究检查cLBP患者的椎间盘和椎体活检。病例有组织取样水平的MC，控件没有。以前手术的患者作为一个亚组。在抗生素预防之前用单独的仪器对组织取样。我们将在活检中应用微生物学方法和组织学，并为显著的细菌生长预定标准，可能的污染和没有增长。微生物学家,外科医生和病理学家对病例或对照的分配视而不见。初级分析分别评估MC1相对于对照和MC2相对于对照的显著生长。先前手术患者的细菌椎间盘生长，融合组中患有大MC和椎体生长的患者都被认为是探索性分析.
背景：挪威医疗和健康研究伦理区域委员会（REC东南部，参考编号2015/697）已批准该研究。参与研究需要书面知情同意书。该研究在ClinicalTrials.gov（NCT03406624）注册。结果将在同行评审的期刊上传播，科学会议和耐心论坛。
背景：NCT03406624。
方法：这个多中心，病例对照研究检查cLBP患者的椎间盘和椎体活检。病例有组织取样水平的MC，控件没有。以前手术的患者作为一个亚组。在抗生素预防之前用单独的仪器对组织取样。我们将在活检中应用微生物学方法和组织学，并为显著的细菌生长预定标准，可能的污染和没有增长。微生物学家,外科医生和病理学家对病例或对照的分配视而不见。初级分析分别评估MC1相对于对照和MC2相对于对照的显著生长。先前手术患者的细菌椎间盘生长，融合组中患有大MC和椎体生长的患者都被认为是探索性分析.
背景：挪威医疗和健康研究伦理区域委员会（REC东南部，参考编号2015/697）已批准该研究。参与研究需要书面知情同意书。该研究在ClinicalTrials.gov（NCT03406624）注册。结果将在同行评审的期刊上传播，科学会议和耐心论坛。
背景：NCT03406624。
