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Lumbar Spinal Fibrosis and TNF Alpha Inhibition

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ClinicalTrials.gov Identifier: NCT00385086
Recruitment Status : Completed
First Posted : October 6, 2006
Last Update Posted : October 16, 2015
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Tracking Information
First Submitted Date  ICMJE October 4, 2006
First Posted Date  ICMJE October 6, 2006
Last Update Posted Date October 16, 2015
Study Start Date  ICMJE February 2007
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 25, 2012)
Sciatica pain [ Time Frame: 10 days after treatment ]
Visual analogue scale of lumbar pain
Original Primary Outcome Measures  ICMJE
 (submitted: October 4, 2006)
Sciatica pain
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 25, 2012)
Functional assessments [ Time Frame: At 10, 30, 90, 180 days ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 4, 2006)
Functional assessments
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Lumbar Spinal Fibrosis and TNF Alpha Inhibition
Official Title  ICMJE Efficacy of TNF-alpha Inhibition in Sciatica With Post-operative Lumbar Spinal Fibrosis
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Post Operative Sciatica by Lumbar Spinal Fibrosis
Intervention  ICMJE
  • Drug: TNF blocker
    Treatment with TNF-alpha blocker
  • Drug: Placebo
    Treatment with placebo
Study Arms  ICMJE
  • Experimental: TNF-alpha blocker
    Treatment with TNF-alpha blocker
    Intervention: Drug: TNF blocker
  • Active Comparator: Placebo
    Treatment with placebo
    Intervention: Drug: Placebo
Publications * Nguyen C, Palazzo C, Grabar S, Feydy A, Sanchez K, Zee N, Quinquis L, Ben Boutieb M, Revel M, Lefèvre-Colau MM, Poiraudeau S, Rannou F. Tumor necrosis factor-α blockade in recurrent and disabling chronic sciatica associated with post-operative peridural lumbar fibrosis: results of a double-blind, placebo randomized controlled study. Arthritis Res Ther. 2015 Nov 19;17:330. doi: 10.1186/s13075-015-0838-4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 15, 2015)
38
Original Enrollment  ICMJE
 (submitted: October 4, 2006)
40
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00385086
Other Study ID Numbers  ICMJE P050312
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Assistance Publique - Hôpitaux de Paris
Study Sponsor  ICMJE Assistance Publique - Hôpitaux de Paris
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Francois Rannou, MD, PhD Assistance Publique - Hôpitaux de Paris
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP