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.

Discussion

Finding treatments that target underlying mechanisms could pose new treatment options for patients with low back pain. Suppression of inflammation could be a treatment strategy for patients with low back pain and Modic changes. This paper presents the design of the BackToBasic study, where we will assess the effect of an anti-inflammatory treatment versus placebo in patients with chronic low back pain and type 1 Modic changes.

The study is registered at ClinicalTrials.gov under the identifier NCT03704363. The EudraCT Number: 2017–004861-29.

Details

Title
The effect of infliximab in patients with chronic low back pain and Modic changes (the BackToBasic study): study protocol of a randomized, double blind, placebo-controlled, multicenter trial
Author
Gjefsen, Elisabeth  VIAFID ORCID Logo  ; Lars Christian Haugli Bråten; Guro Løvik Goll; Wigemyr, Monica; Bolstad, Nils; Valberg, Morten; Elina Iordanova Schistad; Marchand, Gunn Hege; Granviken, Fredrik; Selmer, Kaja Kristine; Froholdt, Anne; Anne Julsrud Haugen; Dagestad, Magnhild Hammersland; Vetti, Nils; Bakland, Gunnstein; Lie, Benedicte Alexandra; Haavardsholm, Espen A; Nilsen, Aksel Thuv; Holmgard, Thor Einar; Kadar, Thomas Istvan; Kvien, Tore; Skouen, Jan Sture; Grøvle, Lars; Brox, Jens Ivar; Espeland, Ansgar; Storheim, Kjersti; John Anker Zwart
Pages
1-14
Section
Study protocol
Publication year
2020
Publication date
2020
Publisher
BioMed Central
e-ISSN
14712474
Source type
Scholarly Journal
Language of publication
English
DOI
https://doi.org/10.1186/s12891-020-03720-5
ProQuest document ID
2461917220
Copyright
© 2020. This work is licensed under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.