Chronic low back pain with Modic changes: Antibiotic treatment and clinical characteristics
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- Institutt for klinisk medisin [10724]
Abstract
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.List of papers
Paper I: Bråten LCH, Rolfsen MP, Espeland A, Wigemyr M, Aßmus J, Froholdt A, Haugen AJ, Marchand GH, Kristoffersen PM, Lutro O, Randen S, Wilhelmsen M, Winsvold BS, Kadar TI, Homgard TE, Vigeland MD, Vetti N, Nygaard ØP, Lie BA, Hellum C, Anke A, Grotle M, Schistad EI, Skouen JS, Grøvle L, Brox JI, Zwart JA, Storheim K. Efficacy of antibiotic treatment in patients with chronic low back pain and Modic changes (the AIM study): a double-blind, randomised, placebo-controlled, multicentre trial. BMJ 2019;367:l5654. doi:10.1136/bmj.l5654. The article is included in the thesis. Also available in DUO: http://urn.nb.no/URN:NBN:no-80398 |
Paper II: Bråten LCH, Grøvle L, Espeland A, Pripp AH, Grotle M, Hellum C, Haugen AJ, Froholdt A, Rolfsen MP, Nygaard ØP, Lutro O, Kristoffersen PM, Anke A, Schistad EI, Skouen JS, Brox JI, Zwart JA, Storheim K. Clinical effect modifiers of antibiotic treatment in patients with chronic low back pain and Modic changes - Secondary analyses of a randomized, placebo-controlled trial (the AIM study). BMC Musculoskeletal Disorders 21, 458 (2020). doi:10.1186/s12891-020-03422-y. The article is included in the thesis. Also available in DUO: http://urn.nb.no/URN:NBN:no-80991 |
Paper III: Bråten LCH, Schistad EI, Espeland A, Kristoffersen PM, Haugen AJ, Marchand GH, Vetti N, Pripp AH, Kadar TI, Skouen JS, Grotle M, Grøvle L, Zwart JA, Brox JI, Storheim K. Modic change types and their short tau inversion recovery signals are not associated with clinical characteristics - a cross sectional study of chronic low back pain patients in the AIM-study. BMC Musculoskeletal Disorders 21, 368 (2020). doi:10.1186/s12891-020-03381-4. The article is included in the thesis. Also available at: https://doi.org/10.1186/s12891-020-03381-4 |