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

Area of Science:

• Orthopedics and Sports Medicine
• Rheumatology
• Radiology

Background:

• Chronic low back pain (LBP) is often associated with Modic changes (MCs).
• Previous studies suggest infliximab may not improve LBP or disability in patients with chronic LBP and type 1 MCs.
• The effect of infliximab on MC edema and its potential to modify treatment outcomes remains unclear.

Purpose of the Study:

• To determine if infliximab reduces Modic change (MC) edema compared to placebo.
• To investigate if MC edema or apparent diffusion coefficient (ADC) values influence infliximab's effectiveness on disability and low back pain (LBP).

Main Methods:

• A randomized trial involving patients with chronic LBP and type 1 MCs.
• Patients received either infliximab infusions or placebo over 98 days.
• MC edema assessed via MRI, with outcomes including Oswestry Disability Index (ODI) and LBP intensity at 5 months.

Main Results:

• Infliximab showed a trend towards reducing MC edema, but the effect was not clinically significant in the primary analysis.
• Neither MC edema status nor ADC values modified the effect of infliximab on disability or LBP.
• A modest reduction in ODI was observed in a subgroup with high baseline edema, but not statistically significant.

Conclusions:

• Infliximab demonstrated no clinically relevant edema-reducing effect in patients with chronic LBP and type 1 MCs.
• MC edema and ADC values did not appear to modify the treatment outcomes of infliximab.
• Further research may be needed to explore other therapeutic targets for chronic LBP associated with Modic changes.