The effect of infliximab in patients with chronic low back pain and Modic changes (the BackToBasic study): study protoco

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(2020) 21:698

STUDY PROTOCOL

Open Access

The effect of infliximab in patients with chronic low back pain and Modic changes (the BackToBasic study): study protocol of a randomized, double blind, placebocontrolled, multicenter trial Elisabeth Gjefsen1,2* , Lars Christian Haugli Bråten1, Guro Løvik Goll3, Monica Wigemyr4, Nils Bolstad5, Morten Valberg6, Elina Iordanova Schistad7, Gunn Hege Marchand8,9, Fredrik Granviken8,10, Kaja Kristine Selmer4,11, Anne Froholdt12, Anne Julsrud Haugen13, Magnhild Hammersland Dagestad14,15, Nils Vetti14,15, Gunnstein Bakland16, Benedicte Alexandra Lie17, Espen A. Haavardsholm3, Aksel Thuv Nilsen16, Thor Einar Holmgard18, Thomas Istvan Kadar19, Tore Kvien2,3, Jan Sture Skouen19,20, Lars Grøvle13, Jens Ivar Brox2,7, Ansgar Espeland14,15, Kjersti Storheim1,21 and John Anker Zwart2,4

Abstract Background: Low back pain is common and a significant number of patients experience chronic low back pain. Current treatment options offer small to moderate effects. Patients with vertebral bone marrow lesions visualized as Modic changes on magnetic resonance imaging may represent a subgroup within the low back pain population. There is evidence for inflammatory mediators being involved in development of Modic changes; hence, suppression of inflammation could be a treatment strategy for these patients. This study examines the effect of anti-inflammatory treatment with the TNF-α inhibitor infliximab in patients with chronic low back pain and Modic changes. Methods/design: The BackToBasic trial is a multicenter, double blind, randomized controlled trial conducted at six hospitals in Norway, comparing intravenous infusions with infliximab with placebo. One hundred twenty-six patients aged 18–65 with chronic low back pain and type 1 Modic changes will be recruited from secondary care outpatients’ clinics. The primary outcome is back pain-specific disability at day 154 (5 months). The study is designed to detect a difference in change of 10 (SD 18) in the Oswestry Disability Index at day 154/ 5 months. The study also aims to refine MRI-assessment, investigate safety and cost-effectiveness and explore the underlying biological mechanisms of Modic changes. (Continued on next page)

* Correspondence: [email protected] 1 Research and Communication Unit for Musculoskeletal Health (FORMI), Oslo University Hospital HF, Ulleval, Bygg 37b, P.O. Box 4956 Nydalen, 0424 Oslo, Norway 2 Faculty of Medicine, University of Oslo, P.O. Box 1072 Blindern, 0316 Oslo, Norway Full list of author information is available at the end of the article © The Author(s). 2020 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commo