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

Elisabeth Gjefsen, Lars Christian Haugli Bråten, Guro Løvik Goll, Monica Wigemyr, Nils Bolstad, Morten Valberg, Elina Iordanova Schistad, Gunn Hege Marchand, Fredrik Granviken, Kaja Kristine Selmer, Anne Froholdt, Anne Julsrud Haugen, Magnhild Hammersland Dagestad, Nils Vetti, Gunnstein Bakland, Benedicte Alexandra Lie, Espen A Haavardsholm, Aksel Thuv Nilsen, Thor Einar Holmgard, Thomas Istvan Kadar, Tore Kvien, Jan Sture Skouen, Lars Grøvle, Jens Ivar Brox, Ansgar Espeland, Kjersti Storheim, John Anker Zwart, Elisabeth Gjefsen, Lars Christian Haugli Bråten, Guro Løvik Goll, Monica Wigemyr, Nils Bolstad, Morten Valberg, Elina Iordanova Schistad, Gunn Hege Marchand, Fredrik Granviken, Kaja Kristine Selmer, Anne Froholdt, Anne Julsrud Haugen, Magnhild Hammersland Dagestad, Nils Vetti, Gunnstein Bakland, Benedicte Alexandra Lie, Espen A Haavardsholm, Aksel Thuv Nilsen, Thor Einar Holmgard, Thomas Istvan Kadar, Tore Kvien, Jan Sture Skouen, Lars Grøvle, Jens Ivar Brox, Ansgar Espeland, Kjersti Storheim, John Anker Zwart

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.

Keywords: Clinical trial; Inflammation; Infliximab; Low back pain; Modic changes; Randomized controlled trial; TNF- α inhibitor.

Conflict of interest statement

Guro L Goll has received honoraria as a speaker for Abbvie, Biogen, Boehringer Ingelheim, Orion Pharma, Pfizer, Roche. Nils Bolstad reports personal fees from Orion Pharma, Roche, Napp Pharmaceuticals, Pfizer and Takeda.

The other authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Flow-chart of the BackToBasic trial

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