Overview

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