Working… Menu

Lumbar Spinal Fibrosis and TNF Alpha Inhibition

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00385086
Recruitment Status : Completed
First Posted : October 6, 2006
Last Update Posted : October 16, 2015
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.

Condition or disease Intervention/treatment Phase
Post Operative Sciatica by Lumbar Spinal Fibrosis Drug: TNF blocker Drug: Placebo Phase 3

Detailed Description:


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.


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


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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of TNF-alpha Inhibition in Sciatica With Post-operative Lumbar Spinal Fibrosis
Study Start Date : February 2007
Actual Primary Completion Date : October 2012
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sciatica

Arm Intervention/treatment
Experimental: TNF-alpha blocker
Treatment with TNF-alpha blocker
Drug: TNF blocker
Treatment with TNF-alpha blocker

Active Comparator: Placebo
Treatment with placebo
Drug: Placebo
Treatment with placebo

Primary Outcome Measures :
  1. Sciatica pain [ Time Frame: 10 days after treatment ]
    Visual analogue scale of lumbar pain

Secondary Outcome Measures :
  1. Functional assessments [ Time Frame: At 10, 30, 90, 180 days ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00385086

Layout table for location information
Hopital Cochin
Paris, France, 75014
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Layout table for investigator information
Principal Investigator: Francois Rannou, MD, PhD Assistance Publique - Hôpitaux de Paris
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Assistance Publique - Hôpitaux de Paris Identifier: NCT00385086    
Other Study ID Numbers: P050312
First Posted: October 6, 2006    Key Record Dates
Last Update Posted: October 16, 2015
Last Verified: October 2015
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Additional relevant MeSH terms:
Layout table for MeSH terms
Pathologic Processes
Sciatic Neuropathy
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Neurologic Manifestations