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

NCT ID: NCT01832844

Last Updated: 2014-03-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2014-01-31

Brief Summary

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.

Conditions

Sciatica

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: SINGLE

Study Groups

Group " with scan prior to infiltration "

Group Type: ACTIVE_COMPARATOR

Group " with scan prior to infiltration "

Intervention Type: PROCEDURE

Scan will be conducted by the operator performing the gesture. He will examine the lumbar spine from L3 to S1, in longitudinal and cross sections and determine the best surgical approach. This will be defined by the largest interspinous space or better visibility of the epidural space. The depth of the epidural space will be noted. The selected stage will be marked with a skin pen to facilitate its location thereafter

Group " without scan "

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

Group Type: PLACEBO_COMPARATOR

Group " without scan "

Intervention Type: PROCEDURE

Interventions

Group " with scan prior to infiltration "

Scan will be conducted by the operator performing the gesture. He will examine the lumbar spine from L3 to S1, in longitudinal and cross sections and determine the best surgical approach. This will be defined by the largest interspinous space or better visibility of the epidural space. The depth of the epidural space will be noted. The selected stage will be marked with a skin pen to facilitate its location thereafter

Intervention Type: PROCEDURE

Group " without scan "

Intervention Type: PROCEDURE

Eligibility Criteria

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

• 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

Principal Investigators

Benoit LE GOFF, Doctor

Role: PRINCIPAL_INVESTIGATOR

Nantes University Hospital

Locations

University Hospital

Nantes, , France

Countries

France

Other Identifiers

RC13_0096

Identifier Type: -

Identifier Source: org_study_id