Involvement of Transverso-sacral- Neo- Articulations or of Transverso-iliac Articulations in Chronic Lumbago

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2010 by Nantes University Hospital
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT01206699
First received: September 21, 2010
Last updated: January 30, 2012
Last verified: September 2010
  Purpose

The specific aim of this study is to determine whether, when treated with corticoid infiltration, certain chronic lumbagos could be explained by the presence of a neo-articulation.The primary criteria is to determine the difference between the mean pain during the latest 24 hours preceding the infiltration and the mean pain preceding the visit S4 (visit 4 weeks after the infiltration)


Condition Intervention Phase
Subjects Suffering of Lateralized Lumbago on Side of the Malformation (Neo-articulation)
Drug: corticoid (altim® 1.5 ml)
Drug: physiological solution (1.5 ml)
Phase 4

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: Involvement of Transverso-sacral- Neo- Articulations or of Transverso-iliac Articulations in Chronic Lumbago: Prospective Multicentric , Double-Blinded, Randomized of the Efficacy of corticoïd Infiltration Versus Physiological Solution Infiltration

Resource links provided by NLM:


Further study details as provided by Nantes University Hospital:

Primary Outcome Measures:
  • To determine the difference between the mean pain during the latest 24 hours preceding the infiltration and the mean pain preceding the visit S4 (visit 4 weeks after the infiltration) [ Time Frame: week 4 ] [ Designated as safety issue: No ]
    To determine whether, when treated with corticoid infiltration, certain chronic lumbagos could be explained by the presence of a neo-articulation.The primary criteria is to determine the difference between the mean pain during the latest 24 hours preceding the infiltration and the mean pain preceding the visit S4 (visit 4 weeks after the infiltration)


Secondary Outcome Measures:
  • To determine whether the improvement by the infiltration of corticoid is present at visit J7 (visit 7 days after the infiltration) and at visit S12 (visit 12 weeks after the infiltration) [ Designated as safety issue: No ]
  • To determine whether an anesthetic positif bloc (decrease of the pain of more than 75 % during the hour that follows the infiltration) is a predictive factor of the final result [ Designated as safety issue: No ]
  • To determine whether corticoïd infiltration can decrease the intake of drugs et decrease the functional handicap [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: September 2010
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: corticoid
Active arm : anesthetic bloc (1 ml of lidocaïne 1%) immediately followed with corticoid (altim® 1.5 ml)
Drug: corticoid (altim® 1.5 ml)
Active arm : anesthetic bloc (1 ml of lidocaïne 1%) immediately followed with corticoid (altim® 1.5 ml)
Placebo Comparator: physiological solution
Control arm: anesthetic bloc (1 ml of lidocaïne 1%) immediately followed with physiological solution (1.5 ml)
Drug: physiological solution (1.5 ml)
Control arm: anesthetic bloc (1 ml of lidocaïne 1%) immediately followed with physiological solution (1.5 ml)

  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)
  • Lateralized lumbago on side of the neo-articulation evolving since more than 3 months
  • Mechanical pain, lumbar low level or gluteal without sciatic irradiation (pain above the knee)
  • Mean pain during the latest 24 hours above 4 on an analogic visual scale (from 0 to 10)- 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 clinical proof for a discal origin : inducing factor, impulsiveness, spinal syndrome, true Lasègue
  • transverse-sacral abnormality of IIb, IIIa, IIIc or IV type with neo-articulation lateralized on side of pain
  • Informed consent form signed

Exclusion Criteria:

  • Age below 18
  • Clinical arguments in favour of a discal origin
  • Pregnant women or women that could become pregnant the day of the infiltration
  • Diabetic patient
  • 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
  • Bilateral lumbago with bilateral neo-articulation
  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: NCT01206699

Contacts
Contact: Joelle Glemarec, Doctor +33 2 40 08 48 24 joelle.glemarec@chu-nantes.fr

Locations
France
Hospital of La Roche/Yon Recruiting
La Roche/Yon, France, 85925
Contact: gregoire Cormier, Doctor       gregoire.cormier@chd-vendee.fr   
Principal Investigator: Gregoire Cormier, Doctor         
Nantes Hospital Recruiting
Nantes, France, 44093
Contact: Joelle glemarec, Doctor    +33 2 40 08 48 24    joelle.glemarec@chu-nantes.fr   
Principal Investigator: joelle Glemarec, Doctor         
Sponsors and Collaborators
Nantes University Hospital
  More Information

No publications provided

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT01206699     History of Changes
Other Study ID Numbers: 10/3-N
Study First Received: September 21, 2010
Last Updated: January 30, 2012
Health Authority: France: Afssaps

Additional relevant MeSH terms:
Congenital Abnormalities
Low Back Pain
Stress, Psychological
Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Behavioral Symptoms
Anesthetics
Pharmaceutical Solutions
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014