Involvement of Transverso-sacral- Neo- Articulations or of Transverso-iliac Articulations in Chronic Lumbago
- Conditions
- Subjects Suffering of Lateralized Lumbago on Side of the Malformation (Neo-articulation)
- Interventions
- Drug: corticoid (altim® 1.5 ml)Drug: physiological solution (1.5 ml)
- Registration Number
- NCT01206699
- Lead Sponsor
- Nantes University Hospital
- 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)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 16
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description corticoid corticoid (altim® 1.5 ml) Active arm : anesthetic bloc (1 ml of lidocaïne 1%) immediately followed with corticoid (altim® 1.5 ml) physiological solution physiological solution (1.5 ml) Control arm: anesthetic bloc (1 ml of lidocaïne 1%) immediately followed with physiological solution (1.5 ml)
- Primary Outcome Measures
Name Time Method 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 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
Name Time Method 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
Trial Locations
- Locations (2)
Hospital of La Roche/Yon
🇫🇷La Roche/Yon, France
Nantes Hospital
🇫🇷Nantes, France