Effects of Control Scan for Presumed Difficult Epidural Infiltrations (ECHORACHIS)

Nantes University Hospital (NUH)

Status: Completed

Conditions: Sciatica

Treatments: Procedure: Group " without scan "; Procedure: Group " with scan prior to infiltration "

Study type: Interventional

Funder types: Other

Identifiers

NCT01832844

RC13_0096

Details and patient eligibility

About

The aim of this care protocol is to study the effects of scan to help epidural infiltration realization, in presumed difficult patients suffering from sciatica.

These scans are already performed in our Rheumatology Department but our objective is to evaluate objectively its contribution for patients and doctors.

Epidural infiltration in young patients, with an easy anatomical identification, causes generally no technical difficulties, therefore this protocol will only include patients presumed to have a difficult infiltration, that means those aged more than 60, and/or with BMI > 30 and/or suffering from scoliosis.

This study concerns patients who are hospitalized in Rheumatology Department (Hospital of Nantes) for their first epidural infiltration for treatment-resistant lombosciatica.

Patient will be randomized at Day 0, before infiltration. This latter will be performed in accordance to current practice.

Tolerance data (pain and satisfaction) will be collected just after the infiltration and eventual complications will be reported within 48 hours after infiltration.

Following treatment of lombosciatic will be realized through hospitalization, as usual.

Scan is a safe, non invasive, painless and non radiating exam. It is the extension of the musculoskeletal clinical exam and it has already changed our rheumatology practices. The investigators hope at the end of this study, that results would confirm that scan can be a help in practice to perform epidural infiltrations.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Major patients hospitalized in Rheumatology Department for performing their first epidural infiltration when sciatica is resistant to medical treatment.
• Inclusion of patients older than 60 years and / or BMI superior to 30 and / or scoliosis

Exclusion criteria

• Refusal to participate
• History of spinal surgery
• Anticoagulant or antiplatelet
• History of spinal malformations type spina bifida
• pregnancy
• Age<18
• Patients under guardianship
• Patients participating to another clinical trial (except non interventional trials)
• Patients unable to achieve the protocol, in the judgment of the investigator

Trial design

80 participants in 2 patient groups, including a placebo group

Group " with scan prior to infiltration "

Active Comparator group

Treatment:

Procedure: Group " with scan prior to infiltration "

Group " without scan "

Placebo Comparator group

Description:

Patients will have a "dummy" lumber spine evaluation in order to put patients in blind conditions

Treatment:

Procedure: Group " without scan "