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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)

Primary Purpose

Discal Sciatica

Status
Unknown status
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Non target epidural infiltration done at L3-L4 stage
Epidural infiltration on contact of disco radicular conflict
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Discal Sciatica focused on measuring Epidural infiltration of Corticoids, L3-L4 stage, On contact of disco radicular conflict, Scan control

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • CHU de Montpellier - Hôpital LapeyronieRecruiting
  • CHU CarémeauRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Non target epidural infiltration at L3-L4 stage

Epidural infiltration on contact of disco radicular conflict

Arm Description

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

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

Outcomes

Primary Outcome Measures

Pain evolution on analogic visual scale (EVA) ay Day 30

Secondary Outcome Measures

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

Full Information

First Posted
May 28, 2014
Last Updated
August 31, 2015
Sponsor
University Hospital, Montpellier
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1. Study Identification

Unique Protocol Identification Number
NCT02151045
Brief Title
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
Acronym
EPI-AMELIE
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Unknown status
Study Start Date
March 2012 (undefined)
Primary Completion Date
March 2017 (Anticipated)
Study Completion Date
March 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Discal Sciatica
Keywords
Epidural infiltration of Corticoids, L3-L4 stage, On contact of disco radicular conflict, Scan control

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
112 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Non target epidural infiltration at L3-L4 stage
Arm Type
Active Comparator
Arm Description
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
Arm Title
Epidural infiltration on contact of disco radicular conflict
Arm Type
Experimental
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Non target epidural infiltration done at L3-L4 stage
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Epidural infiltration on contact of disco radicular conflict
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain evolution on analogic visual scale (EVA) ay Day 30
Time Frame
at Day 30 after infiltration
Secondary Outcome Measure Information:
Title
Pain evolution on analogic visual scal (EVA) at Day 7
Time Frame
at day 7 after infiltration
Title
Pain evolution on analogic visual scal (EVA) at month 3
Time Frame
at month 3 after infiltration
Title
Pain evolution on analogic visual scal (EVA) at month 6
Time Frame
at month 6 after infiltration
Title
Pain evolution on analogic visual scal (EVA) at month 12
Time Frame
at month 12 after infiltration
Title
drug consumption at day 7
Time Frame
at day 7 after infiltration
Title
drug consumption at month 3
Time Frame
at month 3 after infiltration
Title
drug consumption at month 6
Time Frame
at month 6 after infiltration
Title
drug consumption at month 12
Time Frame
at month 12 after infiltration
Title
functional handicap at Day 7
Description
functional handicap is assessed by auto-questionnary
Time Frame
at day 7 after infiltration
Title
functional handicap at month 3
Description
functional handicap is assessed by auto-questionnary
Time Frame
at month 3 after infiltration
Title
functional handicap at month 6
Description
functional handicap is assessed by auto-questionnary
Time Frame
at month 6 after infiltration
Title
functional handicap at month 12
Description
functional handicap is assessed by auto-questionnary
Time Frame
at month 12 after infiltration
Title
professional activity recovery at Day 7
Description
professional activity recovery is assessed by patient's interrogation: if recovery, conditions of recovery, date of recovery. If not recovery, for why?
Time Frame
at day 7 after infiltration
Title
professional activity recovery at month 3
Description
professional activity recovery is assessed by patient's interrogation: if recovery, conditions of recovery, date of recovery. If not recovery, for why?
Time Frame
at month 3 after infiltration
Title
professional activity recovery at month 6
Description
professional activity recovery is assessed by patient's interrogation: if recovery, conditions of recovery, date of recovery. If not recovery, for why?
Time Frame
at month 6 after infiltration
Title
professional activity recovery at month 12
Description
professional activity recovery is assessed by patient's interrogation: if recovery, conditions of recovery, date of recovery. If not recovery, for why?
Time Frame
at month 12 after infiltration
Title
new epidural infiltration or surgery of discal hernia at Day 7
Time Frame
at day 7 after infiltration
Title
new epidural infiltration or surgery of discal hernia at month 3
Time Frame
at month 3 after infiltration
Title
new epidural infiltration or surgery of discal hernia at month 6
Time Frame
at month 6 after infiltration
Title
new epidural infiltration or surgery of discal hernia at month 12
Time Frame
at month 12 after infiltration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eric ET THOMAS, MD
Phone
+33 4 67 33 86 40
Email
e-thomas@chu-montpellier.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric ET THOMAS, MD
Organizational Affiliation
CHU de Montpellier
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Montpellier - Hôpital Lapeyronie
City
Montpellier
ZIP/Postal Code
34295
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric ET THOMAS, MD
Phone
+33 4 67 33 86 40
Email
e-thomas@chu-montpellier.fr
First Name & Middle Initial & Last Name & Degree
Eric ET THOMAS, MD
First Name & Middle Initial & Last Name & Degree
Marlène MG GENTY, MD
First Name & Middle Initial & Last Name & Degree
Catherine CC CYTEVAL, MD
First Name & Middle Initial & Last Name & Degree
Isabelle IT TAVARES, MD
First Name & Middle Initial & Last Name & Degree
Yann YT THOUVENIN, MD
Facility Name
CHU Carémeau
City
Nîmes
ZIP/Postal Code
30000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cécile CG GAUJOUX-VIALA, MD
Phone
+33 4 66 68 31 20
Email
cecilegaujouxviala@yahoo.fr
First Name & Middle Initial & Last Name & Degree
Cécile CG GAUJOUX-VIALA, MD
First Name & Middle Initial & Last Name & Degree
Dominique DB BLIN, MD

12. IPD Sharing Statement

Learn more about this trial

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

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