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dc.contributor.authorBråten, Lars Christian Haugli
dc.contributor.authorGrøvle, Lars
dc.contributor.authorEspeland, Ansgar
dc.contributor.authorPripp, Are Hugo
dc.contributor.authorGrotle, Margreth
dc.contributor.authorHellum, Christian
dc.contributor.authorHaugen, Anne Julsrud
dc.contributor.authorFroholdt, Anne
dc.contributor.authorRolfsen, Mads Peder
dc.contributor.authorNygaard, Øystein Petter
dc.contributor.authorLutro, Olav
dc.contributor.authorKristoffersen, Per Martin
dc.contributor.authorAnke, Audny
dc.contributor.authorSchistad, Ellina Iordanova
dc.contributor.authorSkouen, Jan Sture
dc.contributor.authorBrox, Jens Ivar
dc.contributor.authorZwart, John-Anker
dc.contributor.authorStorheim, Kjersti
dc.PublishedBMC Musculoskeletal Disorders. 2020, 21:458 1-11.
dc.description.abstractBackground Randomised trials on antibiotic treatment for patients with chronic low back pain and vertebral endplate changes visible on MRI (Modic changes) have shown mixed results. A possible explanation might be a real treatment effect in subgroups of the study populations. The purpose of the present study was to explore potential clinical effect modifiers of 3-months oral amoxicillin treatment in patients with chronic low back pain and type I or II Modic changes at the level of a previous lumbar disc herniation. Methods We performed analyses of effect modifiers on data from AIM, a double-blind parallel-group multicentre trial. One hundred eighty patients with chronic low back pain, previous disc herniation, Modic change type I (n = 118) or type II (n = 62) were randomised to 3-months oral treatment with 750 mg amoxicillin (n = 89) or placebo (n = 91) three times daily. The primary outcome was the Roland-Morris Disability Questionnaire (RMDQ) score (possible values 0–24) at 1-year follow-up in the intention-to-treat population. The predefined minimal clinically important between-group mean difference was 4 RMDQ points (not reached in the primary analysis of AIM). Predefined baseline characteristics were analysed as potential effect modifiers, four primary (type I Modic changes, previous disc surgery, positive pain provocation test, high CRP) and five exploratory (disturbed sleep, constant low back pain, short duration of low back pain, younger age, and male) using ANCOVA with interaction terms. Results None of the four primary potential effect modifiers had strong evidence of modifying the treatment effect. In patients younger than 40 years the difference in mean RMDQ score between the treatment groups was − 4.0 (95%CI, − 6.9 to − 1.2), compared to − 0.5 (95%CI, − 2.3 to 1.3) in patients 40 years or older, both in favour of amoxicillin treatment (exploratory analysis). Conclusions We did not find evidence for convincing clinical effect modifiers of antibiotic treatment in patients with chronic low back pain and Modic changes. Our results for younger age in these explorative analyses should not affect clinical treatment decisions without confirmation in future studies.en_US
dc.rightsNavngivelse 4.0 Internasjonal*
dc.titleClinical effect modifiers of antibiotic treatment in patients with chronic low back pain and Modic changes - secondary analyses of a randomised, placebocontrolled trial (the AIM study)en_US
dc.typeJournal articleen_US
dc.typePeer revieweden_US
dc.rights.holderCopyright The Author(s). 2020en_US
dc.source.journalBMC Musculoskeletal Disordersen_US
dc.identifier.citationBMC Musculoskeletal Disorders. 2020, 21, 458.en_US

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