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

NCT ID: NCT02151045

Last Updated: 2015-09-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 112 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2017-03-31

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.

Conditions

Discal Sciatica

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Non target epidural infiltration done at L3-L4 stage

Intervention Type: PROCEDURE

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

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

Group Type: EXPERIMENTAL

Epidural infiltration on contact of disco radicular conflict

Intervention Type: PROCEDURE

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.

Interventions

Non target epidural infiltration done at L3-L4 stage

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

Epidural infiltration on contact of disco radicular conflict

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.

Intervention Type: PROCEDURE

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eric ET THOMAS, MD

Role: PRINCIPAL_INVESTIGATOR

CHU de Montpellier

Locations

CHU de Montpellier - Hôpital Lapeyronie

Montpellier, , France

Site Status: RECRUITING

CHU Carémeau

Nîmes, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Eric ET THOMAS, MD

Role: CONTACT

e-thomas@chu-montpellier.fr

+33 4 67 33 86 40

Facility Contacts

Eric ET THOMAS, MD

Role: primary

e-thomas@chu-montpellier.fr

+33 4 67 33 86 40

Cécile CG GAUJOUX-VIALA, MD

Role: primary

cecilegaujouxviala@yahoo.fr

+33 4 66 68 31 20

Other Identifiers

8708

Identifier Type: -

Identifier Source: org_study_id