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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, LM
dc.contributor.authorHaugen, AJ
dc.contributor.authorFors, Terese
dc.contributor.authorSchistad, Ellina Iordanova
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, JA
dc.date.accessioned2018-01-22T09:16:43Z
dc.date.accessioned2018-03-23T08:46:31Z
dc.date.available2018-01-22T09:16:43Z
dc.date.available2018-03-23T08:46:31Z
dc.date.issued2017
dc.identifier.citationStorheim 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;15(18):596-607en
dc.identifier.issn1745-6215
dc.identifier.urihttps://hdl.handle.net/10642/5806
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
dc.language.isoenen
dc.publisherBioMed Centralen
dc.rights© The Author(s). 2017 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.en
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/
dc.subjectChronic low back painen
dc.subjectAntibioticsen
dc.subjectModic changeen
dc.subjectRandomised controlled trialen
dc.titleAntibiotic treatment In patients with chronic low back pain and Modic changes (the AIM study): study protocol for a randomised controlled trial.en
dc.typeJournal articleen
dc.typePeer revieweden
dc.date.updated2018-01-22T09:16:43Z
dc.description.versionpublishedVersionen
dc.identifier.doihttp://doi.org/10.1186/s13063-017-2306-8
dc.identifier.cristin1537626
dc.source.journalTrials


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© The Author(s). 2017
Open Access
This article is distributed under the terms of the Creative Commons Attribution 4.0
International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and
reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to
the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver
(http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
Med mindre annet er angitt, så er denne innførselen lisensiert som © The Author(s). 2017 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.