Trial lecture - time and place
See Trial Lecture
- First opponent: Professor emeritus Peter Croft, Keele University, Staffordshire, United Kingdom
- Second opponent: Professor Raymond WJG Ostelo, Vrije Universiteit, Amsterdam, The Netherlands
- Third member and chair of the evaluation committee: Professor II Mona Elisabeth Skjelland, Institute of Clinical Medicine, University of Oslo
Chair of defence
Professor II Lars Nordsletten, Institute of Clinical Medicine, University of Oslo
Seksjonsleder Kjersti Storheim, Forsknings- og formidlingsenheten for muskelskjeletthelse (FORMI), Oslo University Hospital
Modic changes are vertebral changes extending from the endplate visible on an MRI, and are associated with back pain. A randomized trial from 2013 concluded that 3 months oral amoxicillin/clavulanate treatment provide a large effect for patients with chronic low back pain and Modic changes. This led to increased antibiotic treatment for low back pain. The scientific environment required that the results should be replicated in further trials before treatment guidelines could be changed for this patient group.
This thesis is based on the AIM-study (Antibiotics in Modic changes) that was initiated to reassess the results of the 2013-trial. At six Norwegian hospitals, a total of 180 patients with chronic low back pain and Modic changes were randomized to 100 days of encapsulated amoxicillin or placebo. All patients, trial staff, researchers and statisticians were blinded to the treatment group.
The results showed that there were no clinically significant differences between the antibiotic group and the placebo group in patient reported outcome measures of disability, pain intensity or quality of life at one year follow-up. Neither were there any clinically relevant differences in subgroups of patients, defined by the type of Modic changes or clinical information.
In addition, it was investigated whether patients with type 1 Modic changes (oedema type) have different clinical outcomes and measurements compared to patients with type 2 Modic changes (fatty type). No relevant differences were found between patients with these types of Modic changes.
The key message from this thesis is that the results of the AIM-study did not support the use of antibiotic treatment for chronic low back pain and Modic Changes.