Comparison of a Cortivazol (ALTIM®) Infiltration of Posterior Epidural Space at L3-L4 Stage Versus an Epidural Infiltration of Cortivazol (ALTIM®) on Contact With Disco Radicular Conflict in Discal Sciatica (EPI-AMELIE)

August 31, 2015 updated by: University Hospital, Montpellier

Comparison of a Cortivazol (ALTIM®) Infiltration of Posterior Epidural Space at L3-L4 Stage Versus an Epidural Infiltration of Cortivazol (ALTIM®) on Contact With Disco Radicular Conflict in Discal Sciatica - Controlled Randomized Trial With Double Blind Evaluation

In discal sciatica, after failure of medical treatment, the investigators propose frequently a spinal infiltration of corticoids the most closer of disco-radicular conflict. Recently, some cases of paraplegia during lumbar foraminal infiltrations have induce a reduction of indications of this type of infiltration. An alternative would be to propose a lateral epidural infiltration on contact with conflict.The objective of this study is to compare, in 112 patients with a less than 6 months discal sciatica, the efficacy on pain of a non target posterior epidural space infiltration of corticoids done at L3-L4 stage on scan control versus an epidural infiltration of the same corticoid done in lateral on contact of disco radicular conflict on scan control.

Study Overview

Study Type

Interventional

Enrollment (Anticipated)

112

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Montpellier, France, 34295
        • Recruiting
        • CHU de Montpellier - Hôpital Lapeyronie
        • Contact:
        • Principal Investigator:
          • Eric ET THOMAS, MD
        • Sub-Investigator:
          • Marlène MG GENTY, MD
        • Sub-Investigator:
          • Catherine CC CYTEVAL, MD
        • Sub-Investigator:
          • Isabelle IT TAVARES, MD
        • Sub-Investigator:
          • Yann YT THOUVENIN, MD
      • Nîmes, France, 30000
        • Recruiting
        • CHU Carémeau
        • Contact:
        • Principal Investigator:
          • Cécile CG GAUJOUX-VIALA, MD
        • Sub-Investigator:
          • Dominique DB BLIN, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Informed consent
  • Aged from 18 to 65 years
  • Affiliated or benefit from an insurance regimen
  • Patient with a sciatic answering to the definition
  • Discal sciatica more than 15 days and less than 6 months
  • Discal hernia (scan or RMI)
  • Negative BHCG and normal coagulation parameters

Exclusion Criteria:

  • History of lumbar surgery
  • Spinal infiltration of corticoids in 30 days before inclusion
  • Iode allergy
  • Anticoagulation therapy, unbalanced type 2 diabetes, instable HTA
  • Motor loss < 4 (muscular testing)
  • Sphincter disorder (cauda equida syndrome)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Non target epidural infiltration at L3-L4 stage

In this control arm, there are patients with a non target posterior epidural space infiltration of corticoids done at L3-L4 stage on scan control.

These patients must have a discal hernia confirmed by scanner or RMI

For patients included in control arm, a non target posterior epidural space infiltration of corticoids will be done at L3-L4 stage on scan control
Experimental: Epidural infiltration on contact of disco radicular conflict

In this experimental arm, there are patients with an epidural infiltration of corticoids done in lateral on contact of disco radicular conflict on scan control.

These patients must have a discal hernia confirmed by scanner or RMI

For patients included in experimental arm, an epidural infiltration of corticoids will be done in lateral on contact of disco radicular conflict on scan control.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pain evolution on analogic visual scale (EVA) ay Day 30
Time Frame: at Day 30 after infiltration
at Day 30 after infiltration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain evolution on analogic visual scal (EVA) at Day 7
Time Frame: at day 7 after infiltration
at day 7 after infiltration
Pain evolution on analogic visual scal (EVA) at month 3
Time Frame: at month 3 after infiltration
at month 3 after infiltration
Pain evolution on analogic visual scal (EVA) at month 6
Time Frame: at month 6 after infiltration
at month 6 after infiltration
Pain evolution on analogic visual scal (EVA) at month 12
Time Frame: at month 12 after infiltration
at month 12 after infiltration
drug consumption at day 7
Time Frame: at day 7 after infiltration
at day 7 after infiltration
drug consumption at month 3
Time Frame: at month 3 after infiltration
at month 3 after infiltration
drug consumption at month 6
Time Frame: at month 6 after infiltration
at month 6 after infiltration
drug consumption at month 12
Time Frame: at month 12 after infiltration
at month 12 after infiltration
functional handicap at Day 7
Time Frame: at day 7 after infiltration
functional handicap is assessed by auto-questionnary
at day 7 after infiltration
functional handicap at month 3
Time Frame: at month 3 after infiltration
functional handicap is assessed by auto-questionnary
at month 3 after infiltration
functional handicap at month 6
Time Frame: at month 6 after infiltration
functional handicap is assessed by auto-questionnary
at month 6 after infiltration
functional handicap at month 12
Time Frame: at month 12 after infiltration
functional handicap is assessed by auto-questionnary
at month 12 after infiltration
professional activity recovery at Day 7
Time Frame: at day 7 after infiltration
professional activity recovery is assessed by patient's interrogation: if recovery, conditions of recovery, date of recovery. If not recovery, for why?
at day 7 after infiltration
professional activity recovery at month 3
Time Frame: at month 3 after infiltration
professional activity recovery is assessed by patient's interrogation: if recovery, conditions of recovery, date of recovery. If not recovery, for why?
at month 3 after infiltration
professional activity recovery at month 6
Time Frame: at month 6 after infiltration
professional activity recovery is assessed by patient's interrogation: if recovery, conditions of recovery, date of recovery. If not recovery, for why?
at month 6 after infiltration
professional activity recovery at month 12
Time Frame: at month 12 after infiltration
professional activity recovery is assessed by patient's interrogation: if recovery, conditions of recovery, date of recovery. If not recovery, for why?
at month 12 after infiltration
new epidural infiltration or surgery of discal hernia at Day 7
Time Frame: at day 7 after infiltration
at day 7 after infiltration
new epidural infiltration or surgery of discal hernia at month 3
Time Frame: at month 3 after infiltration
at month 3 after infiltration
new epidural infiltration or surgery of discal hernia at month 6
Time Frame: at month 6 after infiltration
at month 6 after infiltration
new epidural infiltration or surgery of discal hernia at month 12
Time Frame: at month 12 after infiltration
at month 12 after infiltration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Eric ET THOMAS, MD, CHU de Montpellier

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Anticipated)

March 1, 2017

Study Completion (Anticipated)

March 1, 2017

Study Registration Dates

First Submitted

May 28, 2014

First Submitted That Met QC Criteria

May 29, 2014

First Posted (Estimate)

May 30, 2014

Study Record Updates

Last Update Posted (Estimate)

September 1, 2015

Last Update Submitted That Met QC Criteria

August 31, 2015

Last Verified

August 1, 2015

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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