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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

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

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02151045
Acronym
EPI-AMELIE
Enrollment
112
Registered
2014-05-30
Start date
2012-03-31
Completion date
2017-03-31
Last updated
2015-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Discal Sciatica

Keywords

Epidural infiltration of Corticoids, L3-L4 stage, On contact of disco radicular conflict, Scan control

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.

Interventions

PROCEDURENon 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

PROCEDUREEpidural 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.

Sponsors

University Hospital, Montpellier
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frame
Pain evolution on analogic visual scale (EVA) ay Day 30at Day 30 after infiltration

Secondary

MeasureTime frameDescription
Pain evolution on analogic visual scal (EVA) at month 3at month 3 after infiltration
Pain evolution on analogic visual scal (EVA) at month 6at month 6 after infiltration
Pain evolution on analogic visual scal (EVA) at month 12at month 12 after infiltration
drug consumption at day 7at day 7 after infiltration
drug consumption at month 3at month 3 after infiltration
drug consumption at month 6at month 6 after infiltration
drug consumption at month 12at month 12 after infiltration
functional handicap at Day 7at day 7 after infiltrationfunctional handicap is assessed by auto-questionnary
functional handicap at month 3at month 3 after infiltrationfunctional handicap is assessed by auto-questionnary
Pain evolution on analogic visual scal (EVA) at Day 7at day 7 after infiltration
functional handicap at month 12at month 12 after infiltrationfunctional handicap is assessed by auto-questionnary
professional activity recovery at Day 7at day 7 after infiltrationprofessional 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 3at month 3 after infiltrationprofessional 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 6at month 6 after infiltrationprofessional 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 12at month 12 after infiltrationprofessional 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 7at day 7 after infiltration
new epidural infiltration or surgery of discal hernia at month 3at month 3 after infiltration
new epidural infiltration or surgery of discal hernia at month 6at month 6 after infiltration
new epidural infiltration or surgery of discal hernia at month 12at month 12 after infiltration
functional handicap at month 6at month 6 after infiltrationfunctional handicap is assessed by auto-questionnary

Countries

France

Contacts

Primary ContactEric ET THOMAS, MD
e-thomas@chu-montpellier.fr+33 4 67 33 86 40

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026