Informations générales (source: ClinicalTrials.gov)
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 (EPI-AMELIE)
Interventional
Phase 3
University Hospital, Montpellier (Voir sur ClinicalTrials)
mars 2012
mars 2017
29 juin 2024
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.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHU Carémeau - 30000 - Nîmes - France | Cécile CG GAUJOUX-VIALA, MD | Contact (sur clinicalTrials) | |||
| CHU de Montpellier - Hôpital Lapeyronie - 34295 - Montpellier - France | Eric ET THOMAS, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
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
- 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
- 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)