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

Primary Purpose

Subjects Suffering of Lateralized Lumbago on Side of the Malformation (Neo-articulation)

Status
Terminated
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
corticoid (altim® 1.5 ml)
physiological solution (1.5 ml)
Sponsored by
Nantes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Subjects Suffering of Lateralized Lumbago on Side of the Malformation (Neo-articulation)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital of La Roche/Yon
  • Nantes Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

corticoid

physiological solution

Arm Description

Active arm : anesthetic bloc (1 ml of lidocaïne 1%) immediately followed with corticoid (altim® 1.5 ml)

Control arm: anesthetic bloc (1 ml of lidocaïne 1%) immediately followed with physiological solution (1.5 ml)

Outcomes

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)
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)
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
To determine whether corticoïd infiltration can decrease the intake of drugs et decrease the functional handicap

Full Information

First Posted
September 21, 2010
Last Updated
November 2, 2015
Sponsor
Nantes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01206699
Brief Title
Involvement of Transverso-sacral- Neo- Articulations or of Transverso-iliac Articulations in Chronic Lumbago
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Terminated
Why Stopped
after 4 years of recruitment only 16 patients have been included. Due to this low rate of recruitment it was decided to stop the study
Study Start Date
September 2010 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subjects Suffering of Lateralized Lumbago on Side of the Malformation (Neo-articulation)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
corticoid
Arm Type
Experimental
Arm Description
Active arm : anesthetic bloc (1 ml of lidocaïne 1%) immediately followed with corticoid (altim® 1.5 ml)
Arm Title
physiological solution
Arm Type
Placebo Comparator
Arm Description
Control arm: anesthetic bloc (1 ml of lidocaïne 1%) immediately followed with physiological solution (1.5 ml)
Intervention Type
Drug
Intervention Name(s)
corticoid (altim® 1.5 ml)
Intervention Description
Active arm : anesthetic bloc (1 ml of lidocaïne 1%) immediately followed with corticoid (altim® 1.5 ml)
Intervention Type
Drug
Intervention Name(s)
physiological solution (1.5 ml)
Intervention Description
Control arm: anesthetic bloc (1 ml of lidocaïne 1%) immediately followed with physiological solution (1.5 ml)
Primary Outcome Measure Information:
Title
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)
Description
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)
Time Frame
week 4
Secondary Outcome Measure Information:
Title
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)
Title
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
Title
To determine whether corticoïd infiltration can decrease the intake of drugs et decrease the functional handicap

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Hospital of La Roche/Yon
City
La Roche/Yon
ZIP/Postal Code
85925
Country
France
Facility Name
Nantes Hospital
City
Nantes
ZIP/Postal Code
44093
Country
France

12. IPD Sharing Statement

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

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