Clinical Trial: Efficacy of corticoïd Infiltration Via Sacro-coccygien Hiatus in Discal Sciatica

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Open Randomized Study on the Efficacy of corticoïd Infiltration Versus Physiological Solution Infiltration Versus Feigning of Infiltration Via Sacro-coccygien Hiatus Versus Natural Evolution in D

Brief Summary: The specific aim of this study is to determine whether a medical intervention improve status of patients with discal sciatica and if yes which type of intervention.

Detailed Summary:

The primary criteria is to determine the difference between the mean leg pain during the latest 24 hours preceding the infiltration and the mean leg pain preceding the visit S4 (visit 4 weeks after the infiltration). If difference is of 50% patient will be considered "improved". This study will be organized under three steps:Step 1 : when 124 patients will be randomized: first intermediate analysis to compare efficacy of groups 1+ 2+ 3 versus 4. If significant difference is not demonstrated, study will be stopped at this stage since having demonstrating that infiltration or simulation is inefficient. On the other case, step 2 will be performed.Step 2 : Recruitment is continued only in arms 1 to 3 until reaching a total of 142 randomized patients. Second intermediate analysis to compare efficacy of groups 1+ 2 versus 3. If significant difference is not demonstrated, study will be stopped at this stage since having demonstrating that infiltration is inefficient. On the other case, step 3 will be performed.Step 3 : Recruitment is continued only in arms 1 and 2 until reaching a total of 274 randomized patients. Third intermediate analysis to compare efficacy of groups 1 versus 2.

Visit of inclusion (J0): 1/ notification in the case report form of - information concerning patient pain (mean, maximal and minimal pain during the 24 last hours)- Oswestry questionnaire - impact of discal sciatica on professional activity,- intake of analgesic, co-analgesics and non steroids anti- inflammatory drugs2/ Randomization and infiltration with corresponding treatment arm3/ Thirty minutes after receiving the infiltration, recording of actual patient pain Visits at day 7, weeks 4, 12 and 24 after J0: Notification in the case report form of - information concerning patient pain (mean, maximal and minimal pain during the 24 last hours)- Oswestry questionnaire - impact of discal scia
Sponsor: Nantes University Hospital

Current Primary Outcome: difference between the mean leg pain during the latest 24 hours preceding the infiltration and that preceding the visit S4 [ Time Frame: week 4 ]

To determine the difference between the mean leg pain during the latest 24 hours preceding the infiltration and the mean leg pain preceding the visit S4 (visit 4 weeks after the infiltration). If difference is of 50% patient will be considered "improved".


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • determine whether medical intervention improve status of patients
    To determine whether:- injection of physiological solution or of physiological solution +hydrocortancyl is more efficient than simple feigning of peridural infiltration
  • determine whether medical intervention improve status of patients
    to determine wheter the improvement by the infiltration of corticoid is present at visit of 7 days after the infiltration and at visits of 3 and 6 months after the infiltration
  • To determine whether intervention can decrease the number of surgeries (follow-up of 6 months)
    To determine whether intervention can decrease the number of surgeries (follow-up of 6 months)
  • To determine whether intervention can decrease the intake of drugs
    to determine whether intervention can decrease the intake of drugs
  • To determine whether intervention can decrease the functional handicap
    To determine whether intervention can decrease the functional handicap


Original Secondary Outcome: Same as current

Information By: Nantes University Hospital

Dates:
Date Received: November 29, 2011
Date Started: December 2011
Date Completion:
Last Updated: December 1, 2014
Last Verified: December 2014