BackToBasic: The effect of Infliximab in patients with chronic low back pain and vertebral oedema on MRI scan.A randomized, double blind, placebo-controlled, multicenter trial
- Conditions
- on-specific chronic low back pain of more than 6 months duration. We will only investigate those who have vertebral end-plate chanages(Modic changes) on MRI.MedDRA version: 20.0Level: LLTClassification code 10008837Term: Chronic back painSystem Organ Class: 100000004859Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- EUCTR2017-004861-29-NO
- Lead Sponsor
- FOU, Nevroklinikken, Oslo University Hospital -Ullevål
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 126
-Age between 18 and 65 years
-Low back pain of > 6 months duration with a Numerical Rating Scale (NRS) pain intensity score of 5
-Modic Changes type I in the lumbar vertebral body
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 126
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
-Any contraindication or increased risk of side-effects from Infliximab (such as ongoing infection, recent live vaccination or planned live vaccination, immunocompromised, ongoing glucocorticoid treatment or allergy against any products of the medication)
- Current pregnancy or lactation
- For women of childbearing potential; inadequate birth control, pregnancy, and/or breastfeeding.
- Not able to understand written and spoken Norwegian
- Not able to complete treatment or follow-ups in the study (i.e. contraindications for MRI, severe psychiatric disease, drug abuse or plans of moving)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method