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 GjefsenLars Christian Haugli BråtenGuro Løvik GollMonica WigemyrNils BolstadMorten ValbergElina Iordanova SchistadGunn Hege MarchandFredrik GranvikenKaja Kristine SelmerAnne FroholdtAnne Julsrud HaugenMagnhild Hammersland DagestadNils VettiGunnstein BaklandBenedicte Alexandra LieEspen A HaavardsholmAksel Thuv NilsenThor Einar HolmgardThomas Istvan KadarTore KvienJan Sture SkouenLars GrøvleJens Ivar BroxAnsgar EspelandKjersti StorheimJohn Anker ZwartPublished in: BMC musculoskeletal disorders (2020)
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.