Clinical Trial: 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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 Summary:
Sponsor: University Hospital, Montpellier

Current Primary Outcome: Pain evolution on analogic visual scale (EVA) ay Day 30 [ Time Frame: at Day 30 after infiltration ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Pain evolution on analogic visual scal (EVA) at Day 7 [ Time Frame: at day 7 after infiltration ]
  • Pain evolution on analogic visual scal (EVA) at month 3 [ Time Frame: at month 3 after infiltration ]
  • Pain evolution on analogic visual scal (EVA) at month 6 [ Time Frame: at month 6 after infiltration ]
  • Pain evolution on analogic visual scal (EVA) at month 12 [ Time Frame: at month 12 after infiltration ]
  • drug consumption at day 7 [ Time Frame: at day 7 after infiltration ]
  • drug consumption at month 3 [ Time Frame: at month 3 after infiltration ]
  • drug consumption at month 6 [ Time Frame: at month 6 after infiltration ]
  • drug consumption at month 12 [ Time Frame: at month 12 after infiltration ]
  • functional handicap at Day 7 [ Time Frame: at day 7 after infiltration ]
    functional handicap is assessed by auto-questionnary
  • functional handicap at month 3 [ Time Frame: at month 3 after infiltration ]
    functional handicap is assessed by auto-questionnary
  • functional handicap at month 6 [ Time Frame: at month 6 after infiltration ]
    functional handicap is assessed by auto-questionnary
  • functional handicap at month 12 [ Time Frame: at month 12 after infiltration ]
    functional handicap is assessed by auto-questionnary
  • professional activity recovery at Day 7 [ Time Frame: 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?
  • professional activity recovery at month 3 [ Time Frame: 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?
  • professional activity recovery at month 6 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: at day 7 after infiltration ]
  • new epidural infiltration or surgery of discal hernia at month 3 [ Time Frame: at month 3 after infiltration ]
  • new epidural infiltration or surgery of discal hernia at month 6 [ Time Frame: at month 6 after infiltration ]
  • new epidural infiltration or surgery of discal hernia at month 12 [ Time Frame: at month 12 after infiltration ]


Original Secondary Outcome:

  • Pain evolution on analogic visual scal (EVA) at Day 7 [ Time Frame: at day 7 after infiltration ]
  • Pain evolution on analogic visual scal (EVA) at month 3 [ Time Frame: at month 3 after infiltration ]
  • Pain evolution on analogic visual scal (EVA) at month 6 [ Time Frame: at month 6 after infiltration ]
  • Pain evolution on analogic visual scal (EVA) at month 12 [ Time Frame: at month 12 after infiltration ]
  • drug consumption at day 7 [ Time Frame: at day 7 after infiltration ]
  • drug consumption at month 3 [ Time Frame: at month 3 after infiltration ]
  • drug consumption at month 6 [ Time Frame: at month 6 after infiltration ]
  • drug consumption at month 12 [ Time Frame: at month 12 after infiltration ]
  • functional handicap at Day 7 [ Time Frame: at day 7 after infiltration ]
  • functional handicap at month 3 [ Time Frame: at month 3 after infiltration ]
  • functional handicap at month 6 [ Time Frame: at month 6 after infiltration ]
  • functional handicap at month 12 [ Time Frame: at month 12 after infiltration ]
  • professional activity recovery at Day 7 [ Time Frame: at day 7 after infiltration ]
  • professional activity recovery at month 3 [ Time Frame: at month 3 after infiltration ]
  • professional activity recovery at month 6 [ Time Frame: at month 6 after infiltration ]
  • professional activity recovery at month 12 [ Time Frame: at month 12 after infiltration ]
  • new epidural infiltration or surgery of discal hernia at Day 7 [ Time Frame: at day 7 after infiltration ]
  • new epidural infiltration or surgery of discal hernia at month 3 [ Time Frame: at month 3 after infiltration ]
  • new epidural infiltration or surgery of discal hernia at month 6 [ Time Frame: at month 6 after infiltration ]
  • new epidural infiltration or surgery of discal hernia at month 12 [ Time Frame: at month 12 after infiltration ]


Information By: University Hospital, Montpellier

Dates:
Date Received: May 28, 2014
Date Started: March 2012
Date Completion: March 2017
Last Updated: August 31, 2015
Last Verified: August 2015