ObjectiveThe efficacy of TNF inhibitors for treating chronic low back pain with Modic changes is uncertain. This study investigated the superiority of infliximab over placebo in patients with Modic changes type 1.MethodsIn this multicenter, randomized, triple‐blind, placebo‐controlled trial, patients aged 18‐65 with moderate to severe chronic low back pain and Modic changes type 1 were enrolled from five Norwegian public hospitals between January 2019 and October 2022. Participants were randomly assigned to four intravenous infusions of 5 mg/kg infliximab or placebo. The primary outcome was difference in change in the Oswestry Disability Index (ODI) score from baseline to 5 months. Secondary outcomes included changes in low back pain intensity, disability, and health‐related quality of life. A linear mixed model was used for efficacy analyses.Results128 patients (mean age 43 years, 65.6% women) participated (64 in each group). All patients who received at least one dose of the allocated infusion were included in the primary analyses. The average ODI score change was ‐7.0 (9.7) in the infliximab group and ‐6.4 (10.4) in the placebo group. The difference in the ODI change between the two groups was 1.3 ODI points (95% CI, ‐2.1 to 4.6; p= 0.45). Analyses showed no effect of infliximab compared to placebo on secondary outcomes. Adverse event rates were similar between groups.ConclusionsInfliximab did not demonstrate superiority over placebo in reducing pain‐related disability in patients with moderate to severe chronic low back pain with Modic changes type 1 at 5 months.image

中文翻译：

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TNF 抑制剂对 1 型 Modic 变化的慢性腰痛的疗效：BackToBasic 研究一项随机对照试验


目的TNF 抑制剂治疗伴有 Modic 改变的慢性腰痛的疗效尚不确定。本研究调查了英夫利昔单抗在 1 型 Modic 变化患者中优于安慰剂的方法在这项多中心、随机、三盲、安慰剂对照试验中，2019 年 1 月至 2022 年 10 月期间，来自五家挪威公立医院招募了 18-65 岁的中度至重度慢性腰痛和 1 型 Modic 变化患者。参与者被随机分配到 4 次静脉输注 5 mg/kg 英夫利昔单抗或安慰剂组。主要结局是 Oswestry 残疾指数 （ODI） 评分从基线到 5 个月的变化差异。次要结局包括腰痛强度、残疾和健康相关生活质量的变化。线性混合模型用于疗效分析。结果128 例患者 （平均年龄 43 岁，65.6% 为女性） 参与 （每组 64 例）。所有接受至少一剂分配输注的患者均被纳入主要分析。英夫利昔单抗组的平均 ODI 评分变化为 -7.0 （9.7），安慰剂组为 -6.4 （10.4）。两组之间 ODI 变化的差异为 1.3 个 ODI 点 （95% CI，-2.1 至 4.6;p= 0.45）。分析显示，与安慰剂相比，英夫利昔单抗对次要结局没有影响。两组之间的不良事件发生率相似。结论英夫利昔单抗在减轻 5 个月时伴有 1 型 Modic 改变的中度至重度慢性腰痛患者的疼痛相关残疾方面未表现出优于安慰剂的优势。