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Efficacy of corticoïd Infiltration Via Sacro-coccygien Hiatus in Discal Sciatica (Hiatus)

Primary Purpose

Discal Sciatica

Status
Terminated
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Prednisolone acetate
sham procedure
comparator : physiological solution
Sponsored by
Nantes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Discal Sciatica focused on measuring Discal sciatica, infiltrations, Subjects, evolving

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adult with age equal or above to 18.
  • Subject affiliated to French health insurance (Sécurité Sociale)
  • Sciatic pain evolving since more than 1 month and less than 3 months
  • Leg irradiation (pain above the knee)- True Lasègue- Mean leg pain during the latest 24 hours above 40 on an analogic visual scale (from 0 to 100)
  • Pain induced by palpation in regards to the neo-articulation
  • Pain not relieved by medical treatment with non steroids anti- inflammatory drugs or antalgics No sign of seriousness : no motor deficiency (muscular testing above or equal to 4 on an international scale (from 0 to 5), no sphincter deficiency, mean leg pain during the latest 24 hours below 80 on an analogic visual scale (from 0 to 100).
  • Scanner of MRI since less than 3 months confirming discal hernia L4L5 or L5S1 in accordance with the clinic.
  • Informed consent form signed

Exclusion Criteria:

  • Age below 18
  • Clinical arguments in favour of a non discal origin- Pregnant women
  • Diabetic patient- Past history of diverticulosis complicated with severe arterial hypertension- Patient unable to understand the protocol
  • No autonomy for coming to the hospital (no budget allocated for patient transportation)
  • Hypersensitivity to local anesthetics with "liaison amide"-Hypersensitivity to one of the components-Porphyria
  • Local or generalized infection, suspicion of infection
  • Severe troubles of coagulation, anti-coagulant treatment taken- Imaging non concording
  • Past history of infiltration via the sacro-coccygien hiatus
  • Past history of lombar rachis surgery- Body mass index above 40.
  • Intake of "b-bloquants"- Intake of antiarrythmics possibly giving "torsades de pointe" ("amiodarone, disopyramide, quinidiniques, sotalol,…)"-"Cimétidine" used at doses above or equal to 800mg/day.

Sites / Locations

  • Universitary Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Sham Comparator

No Intervention

Arm Label

corticoïd

physiological solution

feigning of peridural infiltration

no intervention

Arm Description

anesthetic bloc (10 ml of xylocaïne 1%) immediately followed with corticoid (125mg in.5 ml)

anesthetic bloc (10 ml of xylocaïne 1%) immediately followed with physiological solution (20 ml)

feigning of peridural infiltration : anesthetic bloc (10 ml of xylocaïne 1%) immediately followed with placement of empty syringe in peridural.

natural evolution of discal sciatica

Outcomes

Primary Outcome Measures

difference between the mean leg pain during the latest 24 hours preceding the infiltration and that preceding the visit S4
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".

Secondary Outcome Measures

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

Full Information

First Posted
November 29, 2011
Last Updated
December 1, 2014
Sponsor
Nantes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01482897
Brief Title
Efficacy of corticoïd Infiltration Via Sacro-coccygien Hiatus in Discal Sciatica
Acronym
Hiatus
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 Discal Sciatica
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Terminated
Why Stopped
Enrolment stopped on December 01, 2014 since after 3 years, only 13 patients were included (instead of 274) (Date of last visit last patient : October 3, 2013).
Study Start Date
December 2011 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 Description
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 sciatica on professional activity,- intake of analgesic, co-analgesics and non steroids anti- inflammatory drugs

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Discal Sciatica
Keywords
Discal sciatica, infiltrations, Subjects, evolving

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
corticoïd
Arm Type
Experimental
Arm Description
anesthetic bloc (10 ml of xylocaïne 1%) immediately followed with corticoid (125mg in.5 ml)
Arm Title
physiological solution
Arm Type
Placebo Comparator
Arm Description
anesthetic bloc (10 ml of xylocaïne 1%) immediately followed with physiological solution (20 ml)
Arm Title
feigning of peridural infiltration
Arm Type
Sham Comparator
Arm Description
feigning of peridural infiltration : anesthetic bloc (10 ml of xylocaïne 1%) immediately followed with placement of empty syringe in peridural.
Arm Title
no intervention
Arm Type
No Intervention
Arm Description
natural evolution of discal sciatica
Intervention Type
Drug
Intervention Name(s)
Prednisolone acetate
Intervention Description
anesthetic bloc (10 ml of xylocaïne 1%) immediately followed with corticoid (125mg in.5 ml)
Intervention Type
Drug
Intervention Name(s)
sham procedure
Intervention Description
feigning of peridural infiltration : anesthetic bloc (10 ml of xylocaïne 1%) immediately followed with placement of empty syringe in peridural.
Intervention Type
Drug
Intervention Name(s)
comparator : physiological solution
Intervention Description
anesthetic bloc (10 ml of xylocaïne 1%) immediately followed with physiological solution (20 ml)
Primary Outcome Measure Information:
Title
difference between the mean leg pain during the latest 24 hours preceding the infiltration and that preceding the visit S4
Description
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".
Time Frame
week 4
Secondary Outcome Measure Information:
Title
determine whether medical intervention improve status of patients
Description
To determine whether:- injection of physiological solution or of physiological solution +hydrocortancyl is more efficient than simple feigning of peridural infiltration
Title
determine whether medical intervention improve status of patients
Description
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
Title
To determine whether intervention can decrease the number of surgeries (follow-up of 6 months)
Description
To determine whether intervention can decrease the number of surgeries (follow-up of 6 months)
Title
To determine whether intervention can decrease the intake of drugs
Description
to determine whether intervention can decrease the intake of drugs
Title
To determine whether intervention can decrease the functional handicap
Description
To determine whether intervention can decrease the functional handicap

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult with age equal or above to 18. Subject affiliated to French health insurance (Sécurité Sociale) Sciatic pain evolving since more than 1 month and less than 3 months Leg irradiation (pain above the knee)- True Lasègue- Mean leg pain during the latest 24 hours above 40 on an analogic visual scale (from 0 to 100) Pain induced by palpation in regards to the neo-articulation Pain not relieved by medical treatment with non steroids anti- inflammatory drugs or antalgics No sign of seriousness : no motor deficiency (muscular testing above or equal to 4 on an international scale (from 0 to 5), no sphincter deficiency, mean leg pain during the latest 24 hours below 80 on an analogic visual scale (from 0 to 100). Scanner of MRI since less than 3 months confirming discal hernia L4L5 or L5S1 in accordance with the clinic. Informed consent form signed Exclusion Criteria: Age below 18 Clinical arguments in favour of a non discal origin- Pregnant women Diabetic patient- Past history of diverticulosis complicated with severe arterial hypertension- Patient unable to understand the protocol No autonomy for coming to the hospital (no budget allocated for patient transportation) Hypersensitivity to local anesthetics with "liaison amide"-Hypersensitivity to one of the components-Porphyria Local or generalized infection, suspicion of infection Severe troubles of coagulation, anti-coagulant treatment taken- Imaging non concording Past history of infiltration via the sacro-coccygien hiatus Past history of lombar rachis surgery- Body mass index above 40. Intake of "b-bloquants"- Intake of antiarrythmics possibly giving "torsades de pointe" ("amiodarone, disopyramide, quinidiniques, sotalol,…)"-"Cimétidine" used at doses above or equal to 800mg/day.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joelle Glemarec, Doctor
Organizational Affiliation
CHU of Nantes
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Grégoire CORMIER, Doctor
Organizational Affiliation
CHD of La Roche/Yon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitary Hospital
City
Nantes
State/Province
Loire Atlantique
ZIP/Postal Code
44093
Country
France

12. IPD Sharing Statement

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

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