Lumbar Spinal Fibrosis and TNF Alpha Inhibition

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00385086
First received: October 4, 2006
Last updated: February 19, 2013
Last verified: July 2012
  Purpose

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 Intervention Phase
Post Operative Sciatica by Lumbar Spinal Fibrosis
Drug: TNF blocker
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of TNF-alpha Inhibition in Sciatica With Post-operative Lumbar Spinal Fibrosis

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Sciatica pain [ Time Frame: 10 days after treatment ] [ Designated as safety issue: No ]
    Visual analogue scale of lumbar pain


Secondary Outcome Measures:
  • Functional assessments [ Time Frame: At 10, 30, 90, 180 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: February 2007
Estimated Study Completion Date: June 2013
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00385086

Locations
France
Hopital Cochin
Paris, France, 75014
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Francois Rannou, MD, PhD AP-HP
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00385086     History of Changes
Other Study ID Numbers: P050312
Study First Received: October 4, 2006
Last Updated: February 19, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Sciatica
Pain
TNF-alpha
Discectomy
Fibrosis
Spine

Additional relevant MeSH terms:
Fibrosis
Sciatica
Pathologic Processes
Neuralgia
Pain
Neurologic Manifestations
Nervous System Diseases
Sciatic Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014