Measures of inflammation in low back pain (LBP) and anti-TNFa for the treatment of deemed discogenic LBP - an explorative study

Glostrup University Hospital0 个研究点开始时间: 2015年2月9日最近更新: 2016年11月7日

试验速览

暂无简介。

•Patients between 18-65 years
•Operation (spondylodesis) is considered
•A current episode of 3-12 months of low back pain without clinical indications of soon recovery. Back pain [>40 / VAS scale 0 (no pain) – 100 (maximum imaginable pain)] dominates over possible leg pain.
•A conventional MRI no older than 4 weeks are speaking for discogenic LBP
•A degenerative disc (> Pfirrmann grade 3), corresponds location wise to the maximum site of pain.
•Modic change type 1 in previous conventional MRI scan
•The level of the deemed discogenic LBP must correspond by a physician’s ‘springing test’ (a.m. McKenzie) over the same lumbar level, as this will speak for a single level affection.
•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 40
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Women with pregnancy potential have to undergo a pregnancy test prior to injection and scannings. Contraceptives is mandatory up to 3 months after treatment given. Further, planned pregnancy within the first 3 months after treatment cannot participate. Hereby, following the guidelines by Danish Health and Medicines Authority (Sundhedstyrelsen) See 8.2.
•Active or latent tuberculosis
•Hepatitis B and C infection
•Planning surgery in the spine not related to the discugenic pain.
•Invasive cancer disease
•Spondylartropaty, Rheumatoid arthritis or other inflammatory joint disease
•Severe heart disease or failure
•Prior spine infection
•COPD - Chronic obstructive airway disease
•Surgery in the lumbar spine
•Any previous treatment with Etanercept
•Allergy to Humira
•Allergy to Gadolinium contrast
•Decreased estimated glomerular filtration rate (eGFR <60 ml/min/1.73m2) assessed by blood test
•Widespread pain (clear non-organic symptoms)
•Patients with inability to communicate in Danish or in English
•Red flag symptoms.”

发起方

Glostrup University Hospital