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

Discal Sciatica Clinical Trial

— EPI-AMELIE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02151045
• Other study ID #: 8708
• Status: Recruiting
• Phase: Phase 3
• First received: May 28, 2014
• Last updated: August 31, 2015
• Start date: March 2012
• Est. completion date: March 2017

Study information

• Verified date: August 2015
• Source: University Hospital, Montpellier
• Contact: Eric ET THOMAS, MD
• Phone: +33 4 67 33 86 40
• Email: e-thomas[@]chu-montpellier.fr
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 112
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Discal Sciatica
• Sciatica

Intervention

Procedure:
• 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
• 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.

Locations

Country	Name	City	State
France	CHU de Montpellier - Hôpital Lapeyronie	Montpellier
France	CHU Carémeau	Nîmes

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain evolution on analogic visual scale (EVA) ay Day 30		at Day 30 after infiltration	No
Secondary	Pain evolution on analogic visual scal (EVA) at Day 7		at day 7 after infiltration	No
Secondary	Pain evolution on analogic visual scal (EVA) at month 3		at month 3 after infiltration	No
Secondary	Pain evolution on analogic visual scal (EVA) at month 6		at month 6 after infiltration	No
Secondary	Pain evolution on analogic visual scal (EVA) at month 12		at month 12 after infiltration	No
Secondary	drug consumption at day 7		at day 7 after infiltration	No
Secondary	drug consumption at month 3		at month 3 after infiltration	No
Secondary	drug consumption at month 6		at month 6 after infiltration	No
Secondary	drug consumption at month 12		at month 12 after infiltration	No
Secondary	functional handicap at Day 7	functional handicap is assessed by auto-questionnary	at day 7 after infiltration	No
Secondary	functional handicap at month 3	functional handicap is assessed by auto-questionnary	at month 3 after infiltration	No
Secondary	functional handicap at month 6	functional handicap is assessed by auto-questionnary	at month 6 after infiltration	No
Secondary	functional handicap at month 12	functional handicap is assessed by auto-questionnary	at month 12 after infiltration	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	new epidural infiltration or surgery of discal hernia at Day 7		at day 7 after infiltration	No
Secondary	new epidural infiltration or surgery of discal hernia at month 3		at month 3 after infiltration	No
Secondary	new epidural infiltration or surgery of discal hernia at month 6		at month 6 after infiltration	No
Secondary	new epidural infiltration or surgery of discal hernia at month 12		at month 12 after infiltration	No