Lumbar Spinal Fibrosis and TNF Alpha Inhibition

Post Operative Sciatica by Lumbar Spinal Fibrosis Clinical Trial

Official title:

Efficacy of TNF-alpha Inhibition in Sciatica With Post-operative Lumbar Spinal Fibrosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00385086
• Other study ID #: P050312
• Status: Completed
• Phase: Phase 3
• First received: October 4, 2006
• Last updated: October 15, 2015
• Start date: February 2007
• Est. completion date: December 2014

Study information

• Verified date: October 2015
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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 and the recurrence of radicular pain in 25% of cases. Forceful epidural infiltrations, radiotherapy, therapy with D-penicillamine or surgical procedures have had unfavourable results in terms of pain and cost. Magnetic resonance imaging reveals lumbar spinal fibrosis by a hyposignal in the T1 sequence and a hypersignal in T2 sequence around the spinal tissue. Tumor necrosis factor a (TNF-a) is the main cytokine implicated in the formation of tissue fibrosis. In animal models of fibrosis, TNF-a inhibition has been shown to prevent and treat tissue fibrosis.

HYPOTHESIS:

Inhibiting TNF-a could significantly decrease sciatica pain because of lumbar spinal fibrosis after lumbar discectomy by decreasing spinal fibrosis.

METHODS:

We propose a 2-year pilot prospective, randomized, double-blind, controlled study of TNF-a inhibitor (infliximab) in patients with sciatica as a result of postoperative lumbar spinal fibrosis. The infliximab group will receive one intravenous injection of 3 mg/kg infliximab. The control group will receive one physiological serum injection. Patients will be evaluated at day 0, 10, 30, 90, and 180. The main evaluation criterion will be sciatica pain as measured on a visual analog scale, with the objective of a 50% decrease in pain at day 10. This objective leads to a size of 20 patients per group. The other evaluation criteria will be clinical, functional, social, and professional. Patients will be recruited from the rehabilitation unit at Cochin teaching hospital.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: December 2014
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibrosis
• Post Operative Sciatica by Lumbar Spinal Fibrosis
• Sciatica

Intervention

Drug:
• TNF blocker
Treatment with TNF-alpha blocker
• Placebo
Treatment with placebo

Locations

Country	Name	City	State
France	Hopital Cochin	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sciatica pain	Visual analogue scale of lumbar pain	10 days after treatment	No
Secondary	Functional assessments		At 10, 30, 90, 180 days	No