BackToBasic: Infliximab in Chronic Low Back Pain and Modic Changes
Status:
Recruiting
Trial end date:
2021-10-01
Target enrollment:
Participant gender:
Summary
Low-Back Pain (LBP) is the leading cause of disability worldwide. Even though LBP relates to
different underlying pathologies, there are a substantial number of patients with chronic
complaints that have vertebral bone marrow lesions visualized as Modic changes (MC) on
magnetic resonance imaging (MRI). Despite the clinical evidence that MC is painful, the
etiology is unknown and there is currently no established treatment. It has been suggested
that MCs are secondary to a biomechanically induced degradation with a subsequent autoimmune
response, supported by evidence showing that Tumor necrosis factor (TNF)-α plays a critical
role in intervertebral disc degeneration and MCs. Clinical trials suppressing inflammation
with TNF-alfa blockers in patients with acute low back pain and sciatica provide evidence to
support the initiation of a clinical trial assessing the effect of TNF-alfa blockers in
patients with chronic low-back pain and MCs. Since TNF-alfa blockers is an established
treatment for immune-mediated disorders like spondyloarthritis by reducing pain as well as
bone marrow lesions, the researchers aim to assess whether this treatment is effective for
chronic LBP with MCs. In addition refine diagnostic assessment and explore potential
biomarkers, which will provide an increased understanding of underlying factors causing LBP,
and ultimately result in better management and treatment for one of the most costly and
challenging patient populations.
Phase:
Phase 3
Details
Lead Sponsor:
Oslo University Hospital
Collaborators:
Clinical Trial Unit (CTU), Oslo University Hospital Diakonhjemmet Hospital Haukeland University Hospital Ostfold Hospital Trust Østfold Hospital Trust St. Olavs Hospital University Hospital of North Norway Vestre Viken Hospital Trust