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dc.contributor.authorBråten, Lars Christian Haugli
dc.contributor.authorGjefsen, Elisabeth
dc.contributor.authorGervin, Kristina
dc.contributor.authorPripp, Are Hugo
dc.contributor.authorSkouen, Jan Sture
dc.contributor.authorSchistad, Elina Iordanova
dc.contributor.authorPedersen, Linda Margareth
dc.contributor.authorWigemyr, Monica
dc.contributor.authorSelmer, Kaja Kristine
dc.contributor.authorDalsbotten Aass, Hans Christian
dc.contributor.authorGoll, Guro Løvik
dc.contributor.authorBrox, Jens Ivar
dc.contributor.authorEspeland, Ansgar
dc.contributor.authorGrøvle, Lars
dc.contributor.authorZwart, John Anker Henrik
dc.contributor.authorStorheim, Kjersti
dc.description.abstractObjective: Randomized trials testing the effect of antibiotics for chronic low back pain (LBP) with vertebral bone marrow changes on MRI (Modic changes) report inconsistent results. A proposed explanation is subgroups with low grade discitis where antibiotics are effective, but there is currently no method to identify such subgroups. The objective of the present study was to evaluate whether distinct patterns of serum cytokine levels predict any treatment effect of oral amoxicillin at one-year follow-up in patients with chronic low back pain and Modic changes at the level of a previous lumbar disc herniation. Design: We used data from an overpowered, randomized, placebo-controlled trial (the AIM study) that tested 100 days of oral 750 mg amoxicillin vs placebo three times daily in hospital outpatients with chronic (> 6 months) LBP with pain intensity ≥ 5 on a 0– 10 numerical rating scale and Modic changes type 1 (oedema type) or 2 (fatty type). We measured serum levels of 40 inflammatory cytokines at baseline and analysed six predefined potential predictors of treatment effect based on cytokine patterns in 78 randomized patients; three analyses with recursive partitioning, one based on cluster analysis and two based on principal component analyses. The primary outcome was the Roland–Morris Disability Questionnaire score at one-year follow-up in the intention to treat population. The methodology and overall results of the AIM study were published previously. Results: The 78 patients were 25– 62 years old and 47 (60%) were women. None of the three recursive partitioning analyses resulted in any suggested subgroups. Of all main analyses, the largest effect estimate (mean difference between antibiotic and placebo groups) was seen in a subgroup not predefined as of main interest (Cluster category 3+4; − 2.0, 95% CI: − 5.2– 1.3, RMDQ points; p-value for interaction 0.54). Conclusion: Patterns of inflammatory serum cytokine levels did not predict treatment effect of amoxicillin in patients with chronic LBP and Modic changes.en_US
dc.publisherDove Medical Pressen_US
dc.rightsNavngivelse-Ikkekommersiell 4.0 Internasjonal*
dc.titleCytokine Patterns as Predictors of Antibiotic Treatment Effect in Chronic Low Back Pain with Modic Changes: Subgroup Analyses of a Randomized Trial (AIM Study)en_US
dc.typeJournal articleen_US
dc.typePeer revieweden_US
dc.rights.holderCopyright 2023 the authorsen_US
dc.source.journalJournal of Pain Researchen_US
dc.relation.projectNorges forskningsråd: 328657en_US
dc.identifier.citationJournal of Pain Research. 2023, 16, 1713-1724.en_US

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Navngivelse-Ikkekommersiell 4.0 Internasjonal
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