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

Study Overview
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Brief Summary
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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.

Official Title
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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 - Controlled Randomized Trial With Double Blind Evaluation

Conditions
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Discal Sciatica

Intervention / Treatment
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* Procedure: Non target epidural infiltration done at L3-L4 stage
* Procedure: Epidural infiltration on contact of disco radicular conflict


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Non target epidural infiltration at L3-L4 stage<br>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 | Procedure: Non target epidural infiltration done at L3-L4 stage<br>* 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<br>|
| Experimental: Epidural infiltration on contact of disco radicular conflict<br>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 | Procedure: Epidural infiltration on contact of disco radicular conflict<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain evolution on analogic visual scal (EVA) at Day 7 |  | at day 7 after infiltration | 
| Pain evolution on analogic visual scal (EVA) at month 3 |  | at month 3 after infiltration | 
| Pain evolution on analogic visual scal (EVA) at month 6 |  | at month 6 after infiltration | 
| Pain evolution on analogic visual scal (EVA) at month 12 |  | at month 12 after infiltration | 
| drug consumption at day 7 |  | at day 7 after infiltration | 
| drug consumption at month 3 |  | at month 3 after infiltration | 
| drug consumption at month 6 |  | at month 6 after infiltration | 
| drug consumption at month 12 |  | at month 12 after infiltration | 
| functional handicap at Day 7 | functional handicap is assessed by auto-questionnary | at day 7 after infiltration | 
| functional handicap at month 3 | functional handicap is assessed by auto-questionnary | at month 3 after infiltration | 
| functional handicap at month 6 | functional handicap is assessed by auto-questionnary | at month 6 after infiltration | 
| functional handicap at month 12 | functional handicap is assessed by auto-questionnary | at month 12 after infiltration | 
| 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? | at day 7 after infiltration | 
| 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? | at month 3 after infiltration | 
| 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? | at month 6 after infiltration | 
| 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? | at month 12 after infiltration | 
| new epidural infiltration or surgery of discal hernia at Day 7 |  | at day 7 after infiltration | 
| new epidural infiltration or surgery of discal hernia at month 3 |  | at month 3 after infiltration | 
| new epidural infiltration or surgery of discal hernia at month 6 |  | at month 6 after infiltration | 
| new epidural infiltration or surgery of discal hernia at month 12 |  | at month 12 after infiltration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Epidural infiltration of Corticoids, L3-L4 stage, On contact of disco radicular conflict, Scan control