Status:
COMPLETED
Lumbar Spinal Fibrosis and TNF Alpha Inhibition
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Post Operative Sciatica by Lumbar Spinal Fibrosis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
TNF-alpha is the main cytokine implicated in the formation of lumbar spinal fibrosis. Inhibiting TNF-alpha could significantly decrease spinal fibrosis after lumbar discectomy.
Detailed Description
OBJECT: Failed back surgery syndrome is still a challenging therapeutic problem. Clinical studies have demonstrated a significant association between lumbar spinal fibrosis after lumbar discectomy an...
Eligibility Criteria
Inclusion
- age over 18 years old
- sciatica post discectomy
- Pain with VAS \> 40 mm and impossibility to have his usual activity
- Surgical discectomy (less than 2 years and more than 6 months)
- Painless of more than one month and less than one year after the discectomy
- MRI with gadolinium injection of less than 6 months and done more than 6 months after the discectomy
- Presence of spinal fibrosis on MRI (hyposignal in T1 enhanced by gadolinium and hypersignal in T2)
- failure of epidural injection treatment
- absence of tuberculosis
- contraception for woman
- informed consent
Exclusion
- Chronic psychiatric pathologies not treated
- Presence of conflict between nerve root and herniated disc or disc fragments or spinal stenosis
- severe cognitives troubles
- severe cardiac failure (class III or IV)
- Tuberculosis (active or latent), severe infections
- Cancers
- Allergy reactions to the drug studied
- Difficulties to understand french
- Patients enrolled in another clinical trial in the past three months
- pregnancy, breastfeeding or no contraception
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT00385086
Start Date
February 1 2007
End Date
December 1 2014
Last Update
October 16 2015
Active Locations (1)
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1
Hopital Cochin
Paris, Paris, France, 75014