Efficacy of a TNF inhibitor in chronic low back pain with Modic changes type 1: The BackToBasic study A randomized controlled trial

The 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. In 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. 128 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. Infliximab 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.