NCT00385086

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Feb 2007

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 4, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 6, 2006

Completed
4 months until next milestone

Study Start

First participant enrolled

February 1, 2007

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

March 4, 2026

Status Verified

March 1, 2026

Enrollment Period

5.7 years

First QC Date

October 4, 2006

Last Update Submit

March 2, 2026

Conditions

Post Operative Sciatica by Lumbar Spinal Fibrosis

Keywords

SciaticaPainTNF-alphaDiscectomyFibrosisSpine

Outcome Measures

Primary Outcomes (1)

  • Sciatica pain

    Visual analogue scale of lumbar pain

    10 days after treatment

Secondary Outcomes (1)

  • Functional assessments

    At 10, 30, 90, 180 days

Study Arms (2)

TNF-alpha blocker

EXPERIMENTAL

Treatment with TNF-alpha blocker

Drug: TNF blocker

Placebo

ACTIVE COMPARATOR

Treatment with placebo

Drug: Placebo

Interventions

TNF blockerDRUG

Treatment with TNF-alpha blocker

TNF-alpha blocker
PlaceboDRUG

Treatment with placebo

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Cochin

Paris, Paris, 75014, France

Location

Related Publications (1)

  • Nguyen C, Palazzo C, Grabar S, Feydy A, Sanchez K, Zee N, Quinquis L, Ben Boutieb M, Revel M, Lefevre-Colau MM, Poiraudeau S, Rannou F. Tumor necrosis factor-alpha 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.

    PMID: 26596627RESULT

MeSH Terms

Conditions

SciaticaPainFibrosis

Interventions

Tumor Necrosis Factor Inhibitors

Condition Hierarchy (Ancestors)

Sciatic NeuropathyMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNeuralgiaNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPathologic Processes

Intervention Hierarchy (Ancestors)

Anti-Inflammatory AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and Uses

Study Officials

  • Francois Rannou, MD, PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 4, 2006

First Posted

October 6, 2006

Study Start

February 1, 2007

Primary Completion

October 1, 2012

Study Completion

December 1, 2014

Last Updated

March 4, 2026

Record last verified: 2026-03

Locations

FR(1)