英夫利昔单抗治疗慢性下腰痛及Modic改变患者的疗效（BackToBasic研究）：一项随机、双盲、安慰剂对照、多中心试验的研究方案
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.
作者信息
Gjefsen Elisabeth, Bråten Lars Christian Haugli, Goll Guro Løvik, Wigemyr Monica, Bolstad Nils, Valberg Morten, Schistad Elina Iordanova, Marchand Gunn Hege, Granviken Fredrik, Selmer Kaja Kristine, Froholdt Anne, Haugen Anne Julsrud, 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, Zwart John Anker
机构信息
Research and Communication Unit for Musculoskeletal Health (FORMI), Oslo University Hospital HF, Ulleval, Bygg 37b, P.O. Box 4956 Nydalen, 0424, Oslo, Norway.
Faculty of Medicine, University of Oslo, P.O. Box 1072 Blindern, 0316, Oslo, Norway.
出版信息
BMC Musculoskelet Disord. 2020 Oct 21;21(1):698. doi: 10.1186/s12891-020-03720-5.
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.
背景
腰痛很常见，相当多的患者经历慢性腰痛。目前的治疗选择效果甚微至中等。在磁共振成像上表现为Modic改变的椎体骨髓病变患者可能是腰痛人群中的一个亚组。有证据表明炎症介质参与了Modic改变的发生；因此，抑制炎症可能是这些患者的一种治疗策略。本研究探讨肿瘤坏死因子-α抑制剂英夫利昔单抗抗炎治疗对慢性腰痛伴Modic改变患者的疗效。
方法/设计：BackToBasic试验是一项在挪威六家医院进行的多中心、双盲、随机对照试验，比较英夫利昔单抗静脉输注与安慰剂。将从二级护理门诊招募126名年龄在18 - 65岁、患有慢性腰痛和1型Modic改变的患者。主要结局是第154天（5个月）时的背痛特异性残疾。该研究旨在检测第154天/5个月时奥斯威斯残疾指数变化10（标准差18）的差异。该研究还旨在完善磁共振成像评估、调查安全性和成本效益，并探索Modic改变的潜在生物学机制。
讨论
找到针对潜在机制的治疗方法可能为腰痛患者带来新的治疗选择。抑制炎症可能是腰痛伴Modic改变患者的一种治疗策略。本文介绍了BackToBasic研究的设计，我们将评估抗炎治疗与安慰剂对慢性腰痛伴1型Modic改变患者的疗效。该研究已在ClinicalTrials.gov注册，标识符为NCT03704363。欧盟临床试验注册号：2017 - 004861 - 29。
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