Low back pain with and without legg-pain In 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: 18.0 Level: LLT Classification code 10024891 Term: Low back pain System Organ Class: 100000004859 MedDRA version: 18.0 Level: LLT Classification co
Conditions
Interventions
Trade Name: Humira (adalinomap)
Product Name: Humira
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Concentration unit: mg milligram(s)
Concentrati
Sponsors
Glostrup University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
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
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 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.”
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: In this observational pilot trial, where we aim at studying the possible feasibility of TNF-a inhibitor treatment against chronic discugen Low back pain. ;Secondary Objective: In this observational pilot trial, where we aim at studying inflammatory blood markers presence in these LBP cases, and their optional reduction with Humira treatment. Further, the presence and location of optional inflammation following what is deemed to be included in long-lasting, discogenic LBP, using Dynamic Enhanced Contrast (DEC-)MRI.;Primary end point(s): 1 Pain will be evaluated by using the 13 items Pain-Detect questionnaire, which includes measurements of LBP on an ordinal 11-point numerical rating scale (NRS: 0 = no LBP; 10 = worst possible LBP) 2 The validated 24-item Oswestry Disability Index will measure participant-rated LBP disability ;Timepoint(s) of evaluation of this end point: Will be evaluated 3, 6 and 12 months post-baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1 Dynamic Contrast Enhanced -MRI 2. Inflammations markers hsCRP, IL-1, TNF-alfa;Timepoint(s) of evaluation of this end point: Will be evaluated 3, 6 and 12 months post-baseline | — |
Countries
Denmark
Contacts
Public ContactCenter for Rheumatology and Spine
Glostrup University Hospital
Outcome results
None listed