当前位置： SCI文献检索 > BMC MUSCULOSKELETAL DISORDERS期刊下所有文献 > 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.

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.

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.

journal_name

BMC Musculoskelet Disord

journal_title

BMC musculoskeletal disorders

authors

Gjefsen E,Bråten LCH,Goll GL,Wigemyr M,Bolstad N,Valberg M,Schistad EI,Marchand GH,Granviken F,Selmer KK,Froholdt A,Haugen AJ,Dagestad MH,Vetti N,Bakland G,Lie BA,Haavardsholm EA,Nilsen AT,Holmgard TE,Kadar TI,Kvi

doi

10.1186/s12891-020-03720-5

subject

Has Abstract

pub_date

2020-10-21 00:00:00

pages

698

issue

issn

1471-2474

pii

10.1186/s12891-020-03720-5

journal_volume

pub_type

杂志文章

在线工具

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.