Completed

ECHORACHISEffects of Scan Control for Presumed Difficult Epidural Infiltrations: a Monocentric, Prospective, Randomized, Controlled, Simple Blind Trial

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What is being tested

Group " with scan prior to infiltration "

+ Group " without scan "

Procedure
Who is being recruted

Nervous System Diseases+8

+ Neuralgia

+ Neurologic Manifestations

Over 18 Years
+11 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Placebo-Controlled
Interventional
Study Start: April 2013
See protocol details

Summary

Principal SponsorNantes University Hospital
Last updated: March 24, 2014
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2013

Actual date on which the first participant was enrolled.

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.

Principal SponsorNantes University Hospital
Last updated: March 24, 2014
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

80 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Nervous System DiseasesNeuralgiaNeurologic ManifestationsNeuromuscular DiseasesPainPeripheral Nervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsMononeuropathiesSciatic NeuropathySciatica

Criteria

2 inclusion criteria required to participate
Inclusion of patients older than 60 years and / or BMI superior to 30 and / or scoliosis

Major patients hospitalized in Rheumatology Department for performing their first epidural infiltration when sciatica is resistant to medical treatment

9 exclusion criteria prevent from participating
Age < 18

Anticoagulant or antiplatelet

History of spinal malformations type spina bifida

History of spinal surgery

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Active Comparator

Group II

Placebo
Patients will have a &quot;dummy&quot; lumber spine evaluation in order to put patients in blind conditions

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

University Hospital

Nantes, FranceOpen University Hospital in Google Maps
CompletedOne Study Center