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

NCT ID: NCT01206699

Last Updated: 2015-11-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2015-02-28

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)

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

corticoid

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

Group Type: EXPERIMENTAL

corticoid (altim® 1.5 ml)

Intervention Type: DRUG

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

physiological solution

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

Group Type: PLACEBO_COMPARATOR

physiological solution (1.5 ml)

Intervention Type: DRUG

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

Interventions

corticoid (altim® 1.5 ml)

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

Intervention Type: DRUG

physiological solution (1.5 ml)

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nantes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hospital of La Roche/Yon

La Roche/Yon, , France

Nantes Hospital

Nantes, , France

Countries

France

Other Identifiers

10/3-N

Identifier Type: -

Identifier Source: org_study_id