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

History of Changes

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:

MedlinePlus related topics: Sciatica

U.S. FDA Resources

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

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, see Learn About Clinical Studies.

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 Mononeuropathies Nervous System Diseases Neuralgia Neurologic Manifestations	Neuromuscular Diseases Pain Pathologic Processes Peripheral Nervous System Diseases Sciatic Neuropathy Signs and Symptoms

ClinicalTrials.gov processed this record on March 03, 2015

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