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)

University Hospital Center (CHU)

Status and phase: Unknown; Phase 3

Conditions: Discal Sciatica

Treatments: Procedure: Epidural infiltration on contact of disco radicular conflict; Procedure: Non target epidural infiltration done at L3-L4 stage

Study type: Interventional

Funder types: Other

Identifiers

NCT02151045

8708

Details and patient eligibility

About

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.

Enrollment: 112 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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112 participants in 2 patient groups

Non target epidural infiltration at L3-L4 stage

Active Comparator group

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

Treatment:

Procedure: Non target epidural infiltration done at L3-L4 stage

Epidural infiltration on contact of disco radicular conflict

Experimental group

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

Treatment:

Procedure: Epidural infiltration on contact of disco radicular conflict