Low-back pain (LBP) is the single leading cause for disability worldwide, affects all age
groups and has increased from 58 million years lived with disability (YLDs) in 1990 to 83
million YLDs in 2010. The burden is accordingly substantially higher than previously
assessed, causing activity limitation and work absence with subsequently enormous economic
burden. Norwegian expenses reach at least NOK 24 billions annually whereof a substantial part
is hospital costs. The research project responds to this challenge and aim to conduct a
multicenter randomized placebo-controlled trial, complemented by a study of epigenetic and
molecular biomarkers, to re-examine the finding of a recent randomized controlled trial that
antibiotic treatment can cure patients with chronic low back pain (LBP), a former disc
herniation and present Modic Changes (MCs). The hypothesis is that MCs is caused by low
virulent anaerobic organisms in the disc. Investigators also want to add important new
knowledge to the research field beyond the only former RCT by broadening the inclusion
criteria to include both patients with type I and type II MCs, improving the MRI assessment
of MCs, further clarifying the pathogenesis of MCs by studying genetic variability, gene and
protein expression of inflammatory biomarkers, and conducting health economic analysis.
Phase:
Phase 3
Details
Lead Sponsor:
Oslo University Hospital
Collaborators:
Drammen sykehus Haukeland University Hospital St. Olavs Hospital Sykehuset Ostfold University Hospital of North Norway