Status:
TERMINATED
Involvement of Transverso-sacral- Neo- Articulations or of Transverso-iliac Articulations in Chronic Lumbago
Lead Sponsor:
Nantes University Hospital
Conditions:
Subjects Suffering of Lateralized Lumbago on Side of the Malformation (Neo-articulation)
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2015
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT01206699
Start Date
September 1 2010
End Date
February 1 2015
Last Update
November 3 2015
Active Locations (2)
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1
Hospital of La Roche/Yon
La Roche/Yon, France, 85925
2
Nantes Hospital
Nantes, France, 44093