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

• Status: Terminated
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nantes University Hospital
• Treatments: Anesthetics; Lidocaine; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Pharmaceutical Solutions; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

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.