Clinical trial NCT02151045: 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
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Discal Sciatica
Keywords: Epidural infiltration of Corticoids
L3-L4 stage
On contact of disco radicular conflict
Scan control
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2014-05-30
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Pain evolution on analogic visual scale (EVA) ay Day 30
timeFrame: at Day 30 after infiltration
Secondary outcomes:
measure: Pain evolution on analogic visual scal (EVA) at Day 7
timeFrame: at day 7 after infiltration
measure: Pain evolution on analogic visual scal (EVA) at month 3
timeFrame: at month 3 after infiltration
measure: Pain evolution on analogic visual scal (EVA) at month 6
timeFrame: at month 6 after infiltration
measure: Pain evolution on analogic visual scal (EVA) at month 12
timeFrame: at month 12 after infiltration
measure: drug consumption at day 7
timeFrame: at day 7 after infiltration
measure: drug consumption at month 3
timeFrame: at month 3 after infiltration
measure: drug consumption at month 6
timeFrame: at month 6 after infiltration
measure: drug consumption at month 12
timeFrame: at month 12 after infiltration
measure: functional handicap at Day 7
timeFrame: at day 7 after infiltration
measure: functional handicap at month 3
timeFrame: at month 3 after infiltration
measure: functional handicap at month 6
timeFrame: at month 6 after infiltration
measure: functional handicap at month 12
timeFrame: at month 12 after infiltration
measure: professional activity recovery at Day 7
timeFrame: at day 7 after infiltration
measure: professional activity recovery at month 3
timeFrame: at month 3 after infiltration
measure: professional activity recovery at month 6
timeFrame: at month 6 after infiltration
measure: professional activity recovery at month 12
timeFrame: at month 12 after infiltration
measure: new epidural infiltration or surgery of discal hernia at Day 7
timeFrame: at day 7 after infiltration
measure: new epidural infiltration or surgery of discal hernia at month 3
timeFrame: at month 3 after infiltration
measure: new epidural infiltration or surgery of discal hernia at month 6
timeFrame: at month 6 after infiltration
measure: new epidural infiltration or surgery of discal hernia at month 12
timeFrame: at month 12 after infiltration
Other outcomes:
Locations:
city: Montpellier
country: France
facility: CHU de Montpellier - Hôpital Lapeyronie
city: Nîmes
country: France
facility: CHU Carémeau
Study officials:
affiliation: CHU de Montpellier
name: Eric ET THOMAS, MD
role: PRINCIPAL_INVESTIGATOR
References: