1. 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
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Elisabeth Gjefsen, Anne Julsrud Haugen, Fredrik Granviken, Thor Einar Holmgard, Magnhild Hammersland Dagestad, Nils Bolstad, Elina Iordanova Schistad, Thomas Kadar, John-Anker Zwart, Lars Grøvle, Kaja Kristine Selmer, Anne Froholdt, Aksel Thuv Nilsen, G. L. Goll, Tore K Kvien, Benedicte A. Lie, Ansgar Espeland, Morten Valberg, Espen A Haavardsholm, Lars Christian Haugli Bråten, Nils Vetti, Monica Wigemyr, Kjersti Storheim, Jan Sture Skouen, Gunn Hege Marchand, Gunnstein Bakland, and Jens Ivar Brox
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lcsh:Diseases of the musculoskeletal system ,law.invention ,Study Protocol ,Clinical trials ,Tumor necrosis factor (TNF)-α inhibitors ,0302 clinical medicine ,Randomized controlled trial ,law ,TNF- α inhibitor ,Multicenter Studies as Topic ,Medicine ,Orthopedics and Sports Medicine ,030212 general & internal medicine ,Pain Measurement ,Randomized Controlled Trials as Topic ,education.field_of_study ,Lumbar Vertebrae ,Norway ,Middle Aged ,Low back pain ,Oswestry Disability Index ,Clinical trial ,Treatment Outcome ,Randomized controlled trials ,Chronic Pain ,medicine.symptom ,Modic changes ,medicine.drug ,Adult ,medicine.medical_specialty ,Adolescent ,Population ,Placebo ,Young Adult ,03 medical and health sciences ,Rheumatology ,Multicenter trial ,Internal medicine ,Humans ,education ,Aged ,Inflammation ,business.industry ,Low back pains ,Infliximab ,lcsh:RC925-935 ,business ,human activities ,030217 neurology & neurosurgery - Abstract
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 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 Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. 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 in a credit line to the data
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- 2020
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