Fibromyalgia & musculoskeletal pain
Efficacy of a Tumor Necrosis Factor Inhibitor in Chronic Low‐Back Pain With Modic Type 1 Changes: A Randomized Controlled Trial
Authors' conclusion
Infliximab did not demonstrate superiority over placebo in reducing pain-related disability in patients with moderate to severe chronic low-back pain with Modic type 1 changes at five months.
Study context
- Population
- Patients aged 18 to 65 years with moderate to severe chronic low-back pain and Modic type 1 changes, five Norwegian public hospitals, January 2019 to October 2022mean age 43 years, 65.6% women
- Participants
- 128 patients
- Comparison
- Infliximab 5 mg/kg IV, four infusions, vs placebo
- Infliximabn = 64
- Placebon = 64reference
- Primary endpoint
- Difference in change in Oswestry Disability Index (ODI) score from baseline
- Follow-up
- Five months
Methodological detailsmulticentre, triple-blind, placebo-controlled
- Multicentre
- Triple-blind
- Placebo-controlled
Primary result
ODI score change from baseline
Difference
1.3 ODI points
95% CI −2.1 to 4.6
P = 0.45
Change by group
Infliximab
−7.0
average · SD 9.7
Placebo
−6.4
average · SD 10.4
Between Infliximab and Placebo
difference 1.3 ODI points (95% CI −2.1 to 4.6); P = 0.45
As reported in the abstract
Secondary outcomes
Secondary outcomes (low-back pain intensity, disability, health-related quality of life)
- No effect of infliximab compared to placebo on secondary outcomes
Original publication
Efficacy of a Tumor Necrosis Factor Inhibitor in Chronic Low‐Back Pain With Modic Type 1 Changes: A Randomized Controlled Trial. Arthritis Rheumatol. Published 15 January 2025. doi:10.
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