Antibiotics In Modic Changes

Summary

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.

Timeline

Start

2015-06

Primary completion

2018-09-21

Completion

2018-11-06

Publications

• Background Storheim K, Espeland A, Grovle L, Skouen JS, Assmus J, Anke A, Froholdt A, Pedersen LM, Haugen AJ, Fors T, Schistad E, Lutro O, Marchand GH, Kadar T, Vetti N, Randen S, Nygaard OP, Brox JI, Grotle M, Zwart JA. Antibiotic treatment In patients with chronic low back pain and Modic changes (the AIM study): study protocol for a randomised controlled trial. Trials. 2017 Dec 15;18(1):596. doi: 10.1186/s13063-017-2306-8.
• Results Braten 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, Holmgard TE, Vigeland MD, Vetti N, Nygaard OP, Lie BA, Hellum C, Anke A, Grotle M, Schistad EI, Skouen JS, Grovle L, Brox JI, Zwart JA, Storheim K; AIM study group. Efficacy of antibiotic treatment in patients with chronic low back pain and Modic changes (the AIM study): double blind, randomised, placebo controlled, multicentre trial. BMJ. 2019 Oct 16;367:l5654. doi: 10.1136/bmj.l5654.
• Braten LCH, Gjefsen E, Gervin K, Pripp AH, Skouen JS, Schistad E, Pedersen LM, Wigemyr M, Selmer KK, Aass HCD, Goll G, Brox JI, Espeland A, Grovle L, Zwart JA, Storheim K; AIM-study group. Cytokine Patterns as Predictors of Antibiotic Treatment Effect in Chronic Low Back Pain with Modic Changes: Subgroup Analyses of a Randomized Trial (AIM Study). J Pain Res. 2023 May 23;16:1713-1724. doi: 10.2147/JPR.S406079. eCollection 2023.
• Braten LCH, Grovle L, Espeland A, Pripp AH, Grotle M, Helllum C, Haugen AJ, Froholdt A, Rolfsen MP, Nygaard OP, Lutro O, Kristoffersen PM, Anke A, Schistad EI, Skouen JS, Brox JI, Zwart JA, Storheim K; AIM-study group. Clinical effect modifiers of antibiotic treatment in patients with chronic low back pain and Modic changes - secondary analyses of a randomised, placebo-controlled trial (the AIM study). BMC Musculoskelet Disord. 2020 Jul 13;21(1):458. doi: 10.1186/s12891-020-03422-y.
• Grotle M, Braten LC, Brox JI, Espeland A, Zolic-Karlsson Z, Munk Killingmo R, Tingulstad A, Grovle L, Froholdt A, Kristoffersen PM, Wigemyr M, van Tulder MW, Storheim K, Zwart JA; AIM-study group. Cost-utility analysis of antibiotic treatment in patients with chronic low back pain and Modic changes: results from a randomised, placebo-controlled trial in Norway (the AIM study). BMJ Open. 2020 Jun 15;10(6):e035461. doi: 10.1136/bmjopen-2019-035461.
• Braten LCH, Schistad EI, Espeland A, Kristoffersen PM, Haugen AJ, Marchand GH, Vetti N, Pripp AH, Kadar TI, Skouen JS, Grotle M, Grovle L, Zwart JA, Brox JI, Storheim K; AIM-study group. Association of Modic change types and their short tau inversion recovery signals with clinical characteristics- a cross sectional study of chronic low back pain patients in the AIM-study. BMC Musculoskelet Disord. 2020 Jun 10;21(1):368. doi: 10.1186/s12891-020-03381-4.

Drugs

Indications

No indication recorded.