NCT02151045

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
112

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Mar 2012

Longer than P75 for phase_3

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

May 28, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 30, 2014

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

September 1, 2015

Status Verified

August 1, 2015

Enrollment Period

5 years

First QC Date

May 28, 2014

Last Update Submit

August 31, 2015

Conditions

Discal Sciatica

Keywords

Epidural infiltration of CorticoidsL3-L4 stageOn contact of disco radicular conflictScan control

Outcome Measures

Primary Outcomes (1)

  • Pain evolution on analogic visual scale (EVA) ay Day 30

    at Day 30 after infiltration

Secondary Outcomes (20)

  • Pain evolution on analogic visual scal (EVA) at Day 7

    at day 7 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 6

    at month 6 after infiltration

  • Pain evolution on analogic visual scal (EVA) at month 12

    at month 12 after infiltration

  • drug consumption at day 7

    at day 7 after infiltration

  • +15 more secondary outcomes

Study Arms (2)

Non target epidural infiltration at L3-L4 stage

ACTIVE COMPARATOR

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

Procedure: Non target epidural infiltration done at L3-L4 stage

Epidural infiltration on contact of disco radicular conflict

EXPERIMENTAL

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

Procedure: Epidural infiltration on contact of disco radicular conflict

Interventions

Non target epidural infiltration done at L3-L4 stagePROCEDURE

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

Non target epidural infiltration at L3-L4 stage
Epidural infiltration on contact of disco radicular conflictPROCEDURE

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.

Epidural infiltration on contact of disco radicular conflict

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • History of lumbar surgery
  • Iode allergy
  • Anticoagulation therapy, unbalanced type 2 diabetes, instable HTA
  • Motor loss \< 4 (muscular testing)
  • Sphincter disorder (cauda equida syndrome)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHU de Montpellier - Hôpital Lapeyronie

Montpellier, 34295, France

RECRUITING

CHU Carémeau

Nîmes, 30000, France

RECRUITING

Study Officials

  • Eric ET THOMAS, MD

    CHU de Montpellier

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eric ET THOMAS, MD

CONTACT

+33 4 67 33 86 40e-thomas@chu-montpellier.fr

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2014

First Posted

May 30, 2014

Study Start

March 1, 2012

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

September 1, 2015

Record last verified: 2015-08

Locations

FR(2)