Modic Change Edema in Chronic Low Back Pain Treated With Infliximab or Placebo: The BackToBasic Trial.

ABSTRACT:

Study design

Randomized trial.

Objective

To assess whether infliximab is superior to placebo in reducing Modic change (MC) edema, and whether MC edema or apparent diffusion coefficient (ADC) values of MCs modify the effect of infliximab on disability or low back pain (LBP).

Summary of background data

In the present BackToBasic trial, infliximab did not reduce disability or LBP at five months follow-up in patients with chronic LBP and MC type 1. The effect on MC edema and in edema-defined subgroups is unknown.

Materials and methods

Patients with chronic LBP and type 1 MCs were randomized to receive four infliximab infusions or placebo over 98 days. MC edema was assessed using short tau inversion recovery imaging. Primary edema variables were maximum baseline ede

SUBMITTER: Dagestad MH 

PROVIDER: S-EPMC12278752 | biostudies-literature | 2025 Aug

REPOSITORIES: biostudies-literature