Early stage Back Pain associated with break down production and reaction in the adjacent vertebrae as detected as Modic 1 changes on MRI scans.
Study Purpose
Modic type 1 vertebral bone changes in the form of reactive tissue swelling (oedema) or scarring in the vertebrae are present in 6 % of the general population and 35–40 % of the low back pain population. It is strongly associated with low back pain. The aim was to test the efficacy of antibiotic treatment in patients with chronic low back pain (>6 months) and Modic type 1 changes (bone oedema).
Methods
The study was a double-blind RCT with 162 patients whose only known illness was chronic Low Back Pain (LBP) of greater than 6 months duration occurring after a previous disc herniation and who also had bone oedema demonstrated as Modic type 1 changes in the vertebrae adjacent to the previous herniation. Patients were randomised to either 100 days of antibiotic treatment (Bioclavid) or placebo and were blindly evaluated at baseline, end of treatment and at 1-year follow-up.
Outcome measures
Primary outcome, disease-specific disability, lumbar pain. Secondary outcome leg pain, number of hours with pain last 4 weeks, global perceived health, EQ-5D thermometer, days with sick leave, bothersomeness, constant pain, magnetic resonance image (MRI).