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

NCT01482897 | Terminated Phase 3

• 1 other identifier: BRD 11/4-M
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Discal Sciatica

Keywords

Discal sciatica, infiltrations; Subjects; evolving

Outcome Measures

Primary Outcomes (1)

• 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".

  week 4

Secondary Outcomes (5)

• determine whether medical intervention improve status of patients

• determine whether medical intervention improve status of patients

• 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 functional handicap

Study Arms (4)

corticoïd

EXPERIMENTAL

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

Drug: Prednisolone acetate

physiological solution

PLACEBO COMPARATOR

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

Drug: comparator : physiological solution

feigning of peridural infiltration

SHAM COMPARATOR

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

Drug: sham procedure

no intervention

NO INTERVENTION

natural evolution of discal sciatica

Interventions

Prednisolone acetate DRUG

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

corticoïd

sham procedure DRUG

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

feigning of peridural infiltration

comparator : physiological solution DRUG

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

physiological solution

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

Universitary Hospital

Nantes, Loire Atlantique, 44093, France

Location

MeSH Terms

Interventions

prednisolone acetate

Study Officials

• Joelle Glemarec, Doctor

  CHU of Nantes

  PRINCIPAL INVESTIGATOR

• Grégoire CORMIER, Doctor

  CHD of La Roche/Yon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2011
• First Posted: December 1, 2011
• Study Start: December 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: December 2, 2014

Record last verified: 2014-12

Locations

FR (1)