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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2011 by Nantes University Hospital
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT01482897
First received: November 29, 2011
Last updated: November 30, 2011
Last verified: September 2011
  Purpose

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.


Condition Intervention Phase
Discal Sciatica
Drug: Prednisolone acetate
Drug: sham procedure
Drug: comparator : physiological solution
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Nantes University Hospital:

Primary Outcome Measures:
  • difference between the mean leg pain during the latest 24 hours preceding the infiltration and that preceding the visit S4 [ Time Frame: week 4 ] [ Designated as safety issue: No ]
    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 [ Designated as safety issue: No ]
    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 [ Designated as safety issue: No ]
    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) [ Designated as safety issue: No ]
    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 [ Designated as safety issue: No ]
    to determine whether intervention can decrease the intake of drugs

  • To determine whether intervention can decrease the functional handicap [ Designated as safety issue: No ]
    To determine whether intervention can decrease the functional handicap


Estimated Enrollment: 274
Study Start Date: September 2011
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: corticoïd
anesthetic bloc (10 ml of xylocaïne 1%) immediately followed with corticoid (125mg in.5 ml)
Drug: Prednisolone acetate
anesthetic bloc (10 ml of xylocaïne 1%) immediately followed with corticoid (125mg in.5 ml)
Placebo Comparator: physiological solution
anesthetic bloc (10 ml of xylocaïne 1%) immediately followed with physiological solution (20 ml)
Drug: comparator : physiological solution
anesthetic bloc (10 ml of xylocaïne 1%) immediately followed with physiological solution (20 ml)
Sham Comparator: feigning of peridural infiltration
feigning of peridural infiltration : anesthetic bloc (10 ml of xylocaïne 1%) immediately followed with placement of empty syringe in peridural.
Drug: sham procedure
feigning of peridural infiltration : anesthetic bloc (10 ml of xylocaïne 1%) immediately followed with placement of empty syringe in peridural.
No Intervention: no intervention
natural evolution of discal sciatica

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 patient. 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 1274 randomized patient. 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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, suspiscion 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01482897

Contacts
Contact: Joelle GLEMAREC, Doctor 02 40 08 48 37 joelle.glemarec@chu-nantes.fr

Locations
France
Universitary Hospital Recruiting
Nantes, Loire Atlantique, France, 44093
Contact: Joelle Glemarec, Doctor         
Principal Investigator: Joelle GLEMAREC, Doctor         
Sponsors and Collaborators
Nantes University Hospital
Investigators
Principal Investigator: Joelle Glemarec, Doctor CHU of Nantes
Principal Investigator: Grégoire CORMIER, Doctor CHD of La Roche/Yon
  More Information

No publications provided

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT01482897     History of Changes
Other Study ID Numbers: BRD 11/4-M
Study First Received: November 29, 2011
Last Updated: November 30, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Nantes University Hospital:
Discal sciatica, infiltrations
Subjects
evolving

Additional relevant MeSH terms:
Sciatica
Neuralgia
Pain
Neurologic Manifestations
Nervous System Diseases
Sciatic Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Pharmaceutical Solutions
Anesthetics
Prednisolone acetate
Methylprednisolone acetate
Prednisolone
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Therapeutic Uses
Pharmacologic Actions
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on October 02, 2014