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Lumbar Spinal Fibrosis and TNF Alpha Inhibition
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Purpose
| Condition | Intervention | Phase |
|---|---|---|
| Post Operative Sciatica by Lumbar Spinal Fibrosis | Drug: TNF blocker Drug: Placebo | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Investigator) Primary Purpose: Treatment |
| Official Title: | Efficacy of TNF-alpha Inhibition in Sciatica With Post-operative Lumbar Spinal Fibrosis |
- Sciatica pain [ Time Frame: 10 days after treatment ]Visual analogue scale of lumbar pain
- Functional assessments [ Time Frame: At 10, 30, 90, 180 days ]
| Enrollment: | 38 |
| Study Start Date: | February 2007 |
| Study Completion Date: | December 2014 |
| 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 (Adult, Senior) |
| 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
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00385086
| France | |
| Hopital Cochin | |
| Paris, France, 75014 | |
| Principal Investigator: | Francois Rannou, MD, PhD | Assistance Publique - Hôpitaux de Paris |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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: | October 15, 2015 |
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 Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 23, 2017