STUDY DESIGN
The Modic Trial
A multi-centre, Phase 1b study to investigate the efficacy of an intradiscal antibiotic compared to placebo in the treatment of chronic low back pain associated with bone oedema
The study is currently recruiting
Subjects will receive 2 injections of an intradiscal antibiotic, or 2 sham injections
Up to 43 subjects will be recruited
The primary outcome measures are:
Incidence of adverse events
Change from baseline in Low Back Pain Numerical Rating Scale (LBP NRS) score Each question will be assessed by the subject on an 11-point scale with 0 = “no pain” and 10 = “the worst possible pain you can imagine.”
Follow up will be for 12 months