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

Phase 1

Conditions: ow back pain with and without legg-painIn the late periode 1990ies it became clear that various cytokines and other inflammatory elements played a large role for low back pain. One of the known inflammatory substances TNF-a (Tumor Necrosis Factor-a) has been demonstrated in the discs’ nuclear tissue, particular with degeneration.
MedDRA version: 18.0Level: LLTClassification code 10024891Term: Low back painSystem Organ Class: 100000004859
MedDRA version: 18.0Level: LLTClassification code 10024892Term: Low back pain (without radiation)System Organ Class: 100000004859
Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Registration Number: EUCTR2014-005722-35-DK

Lead Sponsor: Glostrup University Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

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

Exclusion Criteria

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

Diabetes

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