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dc.contributor.authorKristoffersen, Per M
dc.contributor.authorBråten, Lars Christian Haugli
dc.contributor.authorVetti, Nils
dc.contributor.authorGrøvle, Lars
dc.contributor.authorHellum, Christian
dc.contributor.authorStorheim, Kjersti
dc.contributor.authorZwart, John-Anker
dc.contributor.authorAssmus, Jörg
dc.contributor.authorEspeland, Ansgar
dc.PublishedEuropean Radiology. 2020, .
dc.description.abstractObjective To evaluate potential MRI-defined effect modifiers of amoxicillin treatment in patients with chronic low back pain and type 1 or 2 Modic changes (MCs) at the level of a previous lumbar disc herniation (index level). Methods In a prospective trial (AIM), 180 patients (25–64 years; mean age 45; 105 women) were randomised to receive amoxicillin or placebo for 3 months. Primary outcome was the Roland-Morris Disability Questionnaire (RMDQ) score (0–24 scale) at 1 year. Mean RMDQ score difference between the groups at 1 year defined the treatment effect; 4 RMDQ points defined the minimal clinically important effect. Predefined baseline MRI features of MCs at the index level(s) were investigated as potential effect modifiers. The predefined primary hypothesis was a better effect of amoxicillin when short tau inversion recovery (STIR) shows more MC-related high signal. To evaluate this hypothesis, we pre-constructed a composite variable with three categories (STIR1/2/3). STIR3 implied MC-related STIR signal increases with volume ≥ 25% and height > 50% of vertebral body and maximum intensity increase ≥ 25% and presence on both sides of the disc. As pre-planned, interaction with treatment was analysed using ANCOVA in the per protocol population (n = 155). Results The STIR3 composite group (n = 41) and STIR signal volume ≥ 25% alone (n = 45) modified the treatment effect of amoxicillin. As hypothesised, STIR3 patients reported the largest effect (− 5.1 RMDQ points; 95% CI − 8.2 to − 1.9; p for interaction = 0.008). Conclusions Predefined subgroups with abundant MC-related index-level oedema on STIR modified the effect of amoxicillin. This finding needs replication and further support. Key Points • In the primary analysis of the AIM trial, the effect of amoxicillin in patients with chronic low back pain and type 1 or 2 MCs did not reach the predefined cut-off for clinical importance. • In the present MRI subgroup analysis of AIM, predefined subgroups with abundant MC-related oedema on STIR reported an effect of amoxicillin. • This finding requires replication and further support.en_US
dc.rightsNavngivelse 4.0 Internasjonal*
dc.titleOedema on STIR modified the effect of amoxicillin as treatment for chronic low back pain with Modic changes—subgroup analysis of a randomized trialen_US
dc.typeJournal articleen_US
dc.typePeer revieweden_US
dc.rights.holderCopyright The Author(s) 2020en_US
dc.source.journalEuropean Radiologyen_US
dc.identifier.citationEuropean Radiology. 2021, 31, 4285-4297.en_US

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Navngivelse 4.0 Internasjonal
Except where otherwise noted, this item's license is described as Navngivelse 4.0 Internasjonal