dc.contributor.author | Bråten, Lars Christian Haugli | |
dc.contributor.author | Rolfsen, Mads Peder | |
dc.contributor.author | Espeland, Ansgar | |
dc.contributor.author | Wigemyr, Monica | |
dc.contributor.author | Assmus, Jörg | |
dc.contributor.author | Froholdt, Anne | |
dc.contributor.author | Haugen, Anne Julsrud | |
dc.contributor.author | Marchand, Gunn Hege | |
dc.contributor.author | Kristoffersen, Per M | |
dc.contributor.author | Lutro, Olav | |
dc.contributor.author | Randen, Sigrun | |
dc.contributor.author | Wilhelmsen, Maja | |
dc.contributor.author | Winsvold, Bendik K S | |
dc.contributor.author | Kadar, Thomas | |
dc.contributor.author | Holmgard, Thor Einar | |
dc.contributor.author | Vigeland, Maria Dehli | |
dc.contributor.author | Vetti, Nils | |
dc.contributor.author | Nygaard, Øystein Petter | |
dc.contributor.author | Lie, Benedicte Alexandra | |
dc.contributor.author | Hellum, Christian | |
dc.contributor.author | Anke, Audny | |
dc.contributor.author | Grotle, Margreth | |
dc.contributor.author | Schistad, Ellina Iordanova | |
dc.contributor.author | Skouen, Jan Sture | |
dc.contributor.author | Grøvle, Lars | |
dc.contributor.author | Brox, Jens Ivar | |
dc.contributor.author | Zwart, John-Anker | |
dc.contributor.author | Storheim, Kjersti | |
dc.date.accessioned | 2020-01-02T08:29:20Z | |
dc.date.available | 2020-01-02T08:29:20Z | |
dc.date.created | 2019-11-02T13:09:54Z | |
dc.date.issued | 2019 | |
dc.identifier.citation | BMJ. British Medical Journal. 2019, 367:I5654 1-10. | nb_NO |
dc.identifier.issn | 1756-1833 | |
dc.identifier.uri | http://hdl.handle.net/11250/2634547 | |
dc.description.abstract | Objective To assess the efficacy of three months of antibiotic treatment compared with placebo in patients with chronic low back pain, previous disc herniation, and vertebral endplate changes (Modic changes). Design Double blind, parallel group, placebo controlled, multicentre trial. Setting Hospital outpatient clinics at six hospitals in Norway. Participants 180 patients with chronic low back pain, previous disc herniation, and type 1 (n=118) or type 2 (n=62) Modic changes enrolled from June 2015 to September 2017. Interventions Patients were randomised to three months of oral treatment with either 750 mg amoxicillin or placebo three times daily. The allocation sequence was concealed by using a computer generated number on the prescription. Main outcome measures The primary outcome was the Roland-Morris Disability Questionnaire (RMDQ) score (range 0-24) at one year follow-up in the intention to treat population. The minimal clinically important between group difference in mean RMDQ score was predefined as 4. Results In the primary analysis of the total cohort at one year, the difference in the mean RMDQ score between the amoxicillin group and the placebo group was −1.6 (95% confidence interval −3.1 to 0.0, P=0.04). In the secondary analysis, the difference in the mean RMDQ score between the groups was −2.3 (−4.2 to−0.4, P=0.02) for patients with type 1 Modic changes and −0.1 (−2.7 to 2.6, P=0.95) for patients with type 2 Modic changes. Fifty patients (56%) in the amoxicillin group experienced at least one drug related adverse event compared with 31 (34%) in the placebo group. Conclusions In this study on patients with chronic low back pain and Modic changes at the level of a previous disc herniation, three months of treatment with amoxicillin did not provide a clinically important benefit compared with placebo. Secondary analyses and sensitivity analyses supported this finding. Therefore, our results do not support the use of antibiotic treatment for chronic low back pain and Modic changes. | nb_NO |
dc.language.iso | eng | nb_NO |
dc.publisher | BMJ Publishing Group | nb_NO |
dc.rights | Navngivelse-Ikkekommersiell 4.0 Internasjonal | * |
dc.rights.uri | http://creativecommons.org/licenses/by-nc/4.0/deed.no | * |
dc.title | Efficacy of antibiotic treatment in patients with chronic low back pain and Modic changes (the AIM study): double blind, randomised, placebo controlled, multicentre trial | nb_NO |
dc.type | Journal article | nb_NO |
dc.type | Peer reviewed | nb_NO |
dc.description.version | publishedVersion | nb_NO |
dc.source.pagenumber | 1-10 | nb_NO |
dc.source.volume | 367:I5654 | nb_NO |
dc.source.journal | BMJ. British Medical Journal | nb_NO |
dc.identifier.doi | 10.1136/bmj.l5654 | |
dc.identifier.cristin | 1743458 | |
dc.description.localcode | This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/. | nb_NO |
cristin.unitcode | 1920,5,0,0 | |
cristin.unitcode | 194,65,30,0 | |
cristin.unitcode | 1920,16,0,0 | |
cristin.unitname | Klinikk for fysikalsk medisin og rehabilitering | |
cristin.unitname | Institutt for nevromedisin og bevegelsesvitenskap | |
cristin.unitname | Nevroklinikken | |
cristin.ispublished | true | |
cristin.qualitycode | 2 | |