Clinical trial NCT01206699: 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
Overall status: TERMINATED
Phase: PHASE4
Conditions: Subjects Suffering of Lateralized Lumbago on Side of the Malformation (Neo-articulation)
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2010-09-22
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)


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

Primary outcomes:
measure: 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)
timeFrame: week 4
Secondary outcomes:
measure: 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)
measure: 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
measure: To determine whether corticoïd infiltration can decrease the intake of drugs et decrease the functional handicap
Other outcomes:
Locations:
city: La Roche/Yon
country: France
facility: Hospital of La Roche/Yon
city: Nantes
country: France
facility: Nantes Hospital
Study officials:
References: