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dc.contributor.authorStorheim, Kjersti
dc.contributor.authorEspeland, Ansgar
dc.contributor.authorGrøvle, Lars
dc.contributor.authorSkouen, Jan Sture
dc.contributor.authorAssmus, Jörg
dc.contributor.authorAnke, Audny
dc.contributor.authorFroholdt, Anne
dc.contributor.authorPedersen, Linda Margareth
dc.contributor.authorHaugen, A. J.
dc.contributor.authorFors, Terese
dc.contributor.authorLutro, Olav
dc.contributor.authorMarchand, Gunn Hege
dc.contributor.authorKadar, Thomas
dc.contributor.authorVetti, Nils
dc.contributor.authorRanden, Solfrid
dc.contributor.authorNygaard, Øystein Petter
dc.contributor.authorBrox, Jens Ivar
dc.contributor.authorGrotle, Margreth
dc.contributor.authorZwart, John-Anker
dc.date.accessioned2018-04-24T10:50:25Z
dc.date.available2018-04-24T10:50:25Z
dc.date.issued2017-12-15
dc.description.abstractBackground: <br>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.<br> Methods/design:<br> 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.<br> Discussion: <br>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.description.sponsorshipThe South East Norway Regional Health Authority, 2015-090 The Western Norway Regional Health Authority, HV 911891 and HV 911938en_US
dc.descriptionSource at: <a href=https://doi.org/10.1186/s13063-017-2306-8> https://doi.org/10.1186/s13063-017-2306-8 </a>en_US
dc.identifier.citationStorheim, K., Espeland, A., Grøvle, L., Skouen, J. S., Assmus, J., Anke, A., ... Zwart, J. (2017). Antibiotic treatment In patients with chronic low back pain and Modic changes (the AIM study): study protocol for a randomised controlled trial. Trials,15(18), 596-607. https://doi.org/10.1186/s13063-017-2306-8en_US
dc.identifier.cristinIDFRIDAID 1537626
dc.identifier.doi10.1186/s13063-017-2306-8
dc.identifier.issn1745-6215
dc.identifier.urihttps://hdl.handle.net/10037/12593
dc.language.isoengen_US
dc.publisherBioMed Centralen_US
dc.relation.journalTrials
dc.rights.accessRightsopenAccessen_US
dc.subjectVDP::Medisinske Fag: 700::Klinisk medisinske fag: 750::Fysikalsk medisin og rehabilitering: 764en_US
dc.subjectVDP::Medical disciplines: 700::Clinical medical disciplines: 750::Physical medicine and rehabilitation: 764en_US
dc.titleAntibiotic treatment In patients with chronic low back pain and Modic changes (the AIM study): study protocol for a randomised controlled trial.en_US
dc.typeJournal articleen_US
dc.typeTidsskriftartikkelen_US
dc.typePeer revieweden_US


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