Chronic low back pain patient with inflammatory pain pattern and Modic I endplate changes Signs and Symptoms Chronic low back pain patient with inflammatory pain pattern and Modic I endplate changes
Conditions
Interventions
All patients receive a subcutaneous injection of Adalimumab 40mg every other week for 12 weeks.
Participants are asked to keep a pain medication diary from baseline until 2 weeks afte
Sponsors
University Hospital of Geneva
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 18-65 years 2. Signed Informed Consent 3. Common low back pain 4. The presence of 2 out of 3 of the following points, indicating inflammatory back pain: 4.1. Insidious onset 4.2. Morning stiffness 4.3. Improvement with exercise 5. Continuous pain for more than 3 months 6. Failure of at least one full course of non steroidal anti-inflammatory drug 7. Pain > 3/10 on a 0 to 10 numeric rating scale over the last 24 hours 8. At least one Modic I modification on lumbar MRI
Exclusion criteria
Exclusion criteria: 1. A diagnosis of spondylarthropathy following standard definition 2. Either : Presence of sacroiliitis on imaging or At least 2 of the following Inflammatory Bowel Disease, Arthritis, Enthesitis, Dactylitis, Uveitis, Psoriasis, Family history of spondylarthropathy, Elevated CRP or sedimentation rate 3. Radicular pain related to disc herniation 4. Neurogenic claudication related to lumbar stenosis 5. Comorbidities impairing with the evaluation of pain or function 6. Concomitant infection 6.1. In case of tuberculosis (positive TBspot) at least one month of antituberculosis treatment is required before considering inclusion 6.2. Active Hepatitis B infection (screening for active HBV infection will be performed) 7. Women of child-bearing age refusing to use contraceptive measure during the study, Pregnancy (pregnancy test will be performed before inclusion), breastfeeding 8. Heart failure (NYHA III and IV) 9. Current treatment with corticosteroids 10. Prior exposure to anti-TNF agents, including adalimumab 11. Inability to comply with the protocol requirements 12. Past history of cancer 13. Demyelinating diseases 14. Allergy to adalimumab or one of its components 15. Unable to read and understand the questionnaires (in French) 16. Poor motivation or other emotional or intellectual problems that are likely to limit the ability of the patient to comply with the protocol requirements
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain is measured using a numerical rating scale (NRS) and the Roland Disability Questionnaire (RDQ) at baseline and 12 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Morning stiffness is measured using a numerical rating scale (NRS) at baseline and 12 weeks 2. Quality of sleep is measured using a numerical rating scale (NRS) at baseline and 12 weeks 3. Patient Global Improvement is measured using a numerical rating scale (NRS) at baseline and 12 weeks 4. Function is measured using Bath Ankylosing Spondilitis disease activity index (BASDAI) at baseline and 12 weeks 5. Health related quality of life is measured using the EuroQol-5 dimensions (EQ-5D) at baseline and 12 weeks 6. Pain medication taken is measured using the Pain Medication Diary at baseline and then every 2 weeks until 2 weeks post-intervention 7. Duration of sick listing is measured by questionnaire at baseline and 2 weeks post-intervention 8. Size of bone oedema is measured using MRI (Modic I) at baseline and 12 weeks | — |
Countries
Switzerland
Outcome results
None listed