Subjects Suffering of Lateralized Lumbago on Side of the Malformation (Neo-articulation)
Conditions
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)
Interventions
DRUGcorticoid (altim® 1.5 ml)
Active arm : anesthetic bloc (1 ml of lidocaïne 1%) immediately followed with corticoid (altim® 1.5 ml)
DRUGphysiological solution (1.5 ml)
Control arm: anesthetic bloc (1 ml of lidocaïne 1%) immediately followed with physiological solution (1.5 ml)
Sponsors
Nantes University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | 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 | — |
Countries
France
Outcome results
None listed