- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02151045
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)
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 Overview
Status
Conditions
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Eric ET THOMAS, MD
- Phone Number: +33 4 67 33 86 40
- Email: e-thomas@chu-montpellier.fr
Study Locations
-
-
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Montpellier, France, 34295
- Recruiting
- CHU de Montpellier - Hôpital Lapeyronie
-
Contact:
- Eric ET THOMAS, MD
- Phone Number: +33 4 67 33 86 40
- Email: e-thomas@chu-montpellier.fr
-
Principal Investigator:
- Eric ET THOMAS, MD
-
Sub-Investigator:
- Marlène MG GENTY, MD
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Sub-Investigator:
- Catherine CC CYTEVAL, MD
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Sub-Investigator:
- Isabelle IT TAVARES, MD
-
Sub-Investigator:
- Yann YT THOUVENIN, MD
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Nîmes, France, 30000
- Recruiting
- CHU Carémeau
-
Contact:
- Cécile CG GAUJOUX-VIALA, MD
- Phone Number: +33 4 66 68 31 20
- Email: cecilegaujouxviala@yahoo.fr
-
Principal Investigator:
- Cécile CG GAUJOUX-VIALA, MD
-
Sub-Investigator:
- Dominique DB BLIN, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Sponsor
Investigators
- Principal Investigator: Eric ET THOMAS, MD, CHU de Montpellier
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 8708
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