Subjects Suffering of Lateralized Lumbago on Side of the Malformation (Neo-articulation) Clinical Trial
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
| Verified date | September 2010 |
| Source | Nantes University Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | France: Afssaps |
| Study type | Interventional |
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)
| Status | Terminated |
| Enrollment | 16 |
| Est. completion date | February 2015 |
| Est. primary completion date | February 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| France | Hospital of La Roche/Yon | La Roche/Yon | |
| France | Nantes Hospital | Nantes |
| Lead Sponsor | Collaborator |
|---|---|
| Nantes University Hospital |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No |
| Secondary | 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) | No | ||
| Secondary | 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 | No | ||
| Secondary | To determine whether corticoïd infiltration can decrease the intake of drugs et decrease the functional handicap | No |