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

Study Overview
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Brief Summary
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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)

Official Title
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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

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

Intervention / Treatment
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* Drug: corticoid (altim® 1.5 ml)
* Drug: physiological solution (1.5 ml)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: corticoid<br>Active arm : anesthetic bloc (1 ml of lidocaïne 1%) immediately followed with corticoid (altim® 1.5 ml) | Drug: corticoid (altim® 1.5 ml)<br>* Active arm : anesthetic bloc (1 ml of lidocaïne 1%) immediately followed with corticoid (altim® 1.5 ml)<br>|
| Placebo Comparator: physiological solution<br>Control arm: anesthetic bloc (1 ml of lidocaïne 1%) immediately followed with physiological solution (1.5 ml) | Drug: physiological solution (1.5 ml)<br>* Control arm: anesthetic bloc (1 ml of lidocaïne 1%) immediately followed with physiological solution (1.5 ml)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  |