Lumbar Spinal Fibrosis and TNF Alpha Inhibition

• Status: Completed
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: Adrenergic alpha-Antagonists; Tumor Necrosis Factor Inhibitors

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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