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dc.contributor.authorStorheim, Kjerstien_US
dc.contributor.authorEspeland, Ansgaren_US
dc.contributor.authorGrøvle, Larsen_US
dc.contributor.authorSkouen, Jan Stureen_US
dc.contributor.authorAssmus, Jörgen_US
dc.contributor.authorAnke, Audnyen_US
dc.contributor.authorFroholdt, Anneen_US
dc.contributor.authorPedersen, LMen_US
dc.contributor.authorHaugen, AJen_US
dc.contributor.authorFors, Tereseen_US
dc.contributor.authorSchistad, Ellina Iordanovaen_US
dc.contributor.authorLutro, Olaven_US
dc.contributor.authorMarchand, Gunn Hegeen_US
dc.contributor.authorKadar, Thomasen_US
dc.contributor.authorVetti, Nilsen_US
dc.contributor.authorRanden, Solfriden_US
dc.contributor.authorNygaard, Øystein Petteren_US
dc.contributor.authorBrox, Jens Ivaren_US
dc.contributor.authorGrotle, Margrethen_US
dc.contributor.authorZwart, JAen_US
dc.PublishedStorheim K, Espeland A, Grøvle L, Skouen Skouen JS, Assmus J, Anke A, Froholdt A, Pedersen L, Haugen A, Fors T, Schistad E, Lutro O, Marchand GH, Kadar T, Vetti N, Randen S, Nygaard ØP, Brox JI, Grotle M, Zwart J. Antibiotic treatment In patients with chronic low back pain and Modic changes (the AIM study): study protocol for a randomised controlled trial.. Trials. 2017;18:596eng
dc.description.abstractBackground: A previous randomised controlled trial (RCT) of patients with chronic low back pain (LBP) and vertebral bone marrow (Modic) changes (MCs) on magnetic resonance imaging (MRI), reported that a 3-month, high-dose course of antibiotics had a better effect than placebo at 12 months’ follow-up. The present study examines the effects of antibiotic treatment in chronic LBP patients with MCs at the level of a lumbar disc herniation, similar to the previous study. It also aims to assess the cost-effectiveness of the treatment, refine the MRI assessment of MCs, and further evaluate the impact of the treatment and the pathogenesis of MCs by studying genetic variability and the gene and protein expression of inflammatory biomarkers. Methods/design: A double-blinded RCT is conducted at six hospitals in Norway, comparing orally administered amoxicillin 750 mg, or placebo three times a day, over a period of 100 days in patients with chronic LBP and type I or II MCs at the level of a MRI-confirmed lumbar disc herniation within the preceding 2 years. The inclusion will be stopped when at least 80 patients are included in each of the two MC type groups. In each MC type group, the study is designed to detect (β = 0.1, α = 0.05) a mean difference of 4 (standard deviation 5) in the Roland Morris Disability Questionnaire score between the two treatment groups (amoxicillin or placebo) at 1-year follow-up. The study includes cost-effectiveness measures. Blood samples are assessed for security measures and for possible inflammatory mediators and biomarkers at different time points. MCs are evaluated on MRI at baseline and after 12 months. A blinded intention-to-treat analysis of treatment effects will be performed in the total sample and in each MC type group. Discussion: To ensure the appropriate use of antibiotic treatment, its effect in chronic LBP patients with MCs should be re-assessed. This study will investigate the effects and cost-effectiveness of amoxicillin in patients with chronic LBP and MCs at the level of a disc herniation. The study may also help to refine imaging and characterise the biomarkers of MCs.en_US
dc.publisherBioMed Centraleng
dc.rightsAttribution CC BYeng
dc.subjectChronic low back paineng
dc.subjectModic changeeng
dc.subjectRandomised controlled trialeng
dc.titleAntibiotic treatment In patients with chronic low back pain and Modic changes (the AIM study): study protocol for a randomised controlled trialen_US
dc.typePeer reviewed
dc.typeJournal article
dc.rights.holderCopyright 2017 The Author(s)

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