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

Phase 4TerminatedNCT01206699

Nantes University Hospital16 enrolled

Overview

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)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

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

Interventions

corticoid (altim® 1.5 ml)DRUG

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

physiological solution (1.5 ml)DRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Hospital of La Roche/Yon

La Roche/Yon, France

Nantes Hospital

Nantes, France

Outcomes

Primary Outcomes

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)

Time frame: week 4

Secondary Outcomes

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

Data from ClinicalTrials.gov

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