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
- Conditions
- Discal Sciatica
- Interventions
- Procedure: Epidural infiltration on contact of disco radicular conflictProcedure: Non target epidural infiltration done at L3-L4 stage
- Registration Number
- NCT02151045
- Lead Sponsor
- University Hospital, Montpellier
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 112
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Epidural infiltration on contact of disco radicular conflict 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 Non target epidural infiltration at L3-L4 stage Non target epidural infiltration done 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
- Primary Outcome Measures
Name Time Method Pain evolution on analogic visual scale (EVA) ay Day 30 at Day 30 after infiltration
- Secondary Outcome Measures
Name Time Method drug consumption at month 6 at month 6 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 12 at month 12 after infiltration functional handicap at month 3 at month 3 after infiltration functional handicap is assessed by auto-questionnary
Pain evolution on analogic visual scal (EVA) at month 6 at month 6 after infiltration functional handicap at Day 7 at day 7 after infiltration functional handicap is assessed by auto-questionnary
new epidural infiltration or surgery of discal hernia at month 3 at month 3 after infiltration Pain evolution on analogic visual scal (EVA) at Day 7 at day 7 after infiltration professional activity recovery at month 3 at month 3 after infiltration professional activity recovery is assessed by patient's interrogation: if recovery, conditions of recovery, date of recovery. If not recovery, for why?
new epidural infiltration or surgery of discal hernia 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 functional handicap at month 6 at month 6 after infiltration functional handicap is assessed by auto-questionnary
functional handicap at month 12 at month 12 after infiltration functional handicap is assessed by auto-questionnary
professional activity recovery at Day 7 at day 7 after infiltration professional activity recovery is assessed by patient's interrogation: if recovery, conditions of recovery, date of recovery. If not recovery, for why?
new epidural infiltration or surgery of discal hernia at month 6 at month 6 after infiltration drug consumption at month 12 at month 12 after infiltration professional activity recovery at month 6 at month 6 after infiltration professional activity recovery is assessed by patient's interrogation: if recovery, conditions of recovery, date of recovery. If not recovery, for why?
professional activity recovery at month 12 at month 12 after infiltration professional activity recovery is assessed by patient's interrogation: if recovery, conditions of recovery, date of recovery. If not recovery, for why?
new epidural infiltration or surgery of discal hernia at Day 7 at day 7 after infiltration
Trial Locations
- Locations (2)
CHU Carémeau
🇫🇷Nîmes, France
CHU de Montpellier - Hôpital Lapeyronie
🇫🇷Montpellier, France