Status:
TERMINATED
Efficacy of corticoïd Infiltration Via Sacro-coccygien Hiatus in Discal Sciatica
Lead Sponsor:
Nantes University Hospital
Conditions:
Discal Sciatica
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 th...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT01482897
Start Date
December 1 2011
End Date
December 1 2014
Last Update
December 2 2014
Active Locations (1)
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1
Universitary Hospital
Nantes, Loire Atlantique, France, 44093