Clinical trial NCT01832844: Effects of Control Scan for Presumed Difficult Epidural Infiltrations (ECHORACHIS)
Official title: Effects of Scan Control for Presumed Difficult Epidural Infiltrations: a Monocentric, Prospective, Randomized, Controlled, Simple Blind Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sciatica
Keywords: Scan control
Epidural infiltration
visual analogue scale (VAS)
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2013-04-16
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.


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

Primary outcomes:
measure: Visual analogue scale measuring the pain during infiltration
timeFrame: 10min after the infiltration
Secondary outcomes:
measure: Infiltration evaluation: procedure time between skin passage and release of the needle
timeFrame: 10min after the infiltration
measure: Infiltration evaluation: attempts number before correct positioning of needle
timeFrame: 10min after the infiltration
measure: Infiltration evaluation: number of puncture sites
timeFrame: 10min after the infiltration
measure: Infiltration evaluation: number of failures
timeFrame: 10min after the infiltration
measure: Infiltration tolerance : VAS for pain (graduating from 0 to 10)
timeFrame: 48 hours
measure: Infiltration tolerance : infiltration complications (headaches, pain at the puncture site, other)
timeFrame: 48 hours
measure: Distance skin- épidural space (mm) L3-L4, L4-L5 and L5-S1
timeFrame: 10min after the infiltration
measure: Minimal interspinous distance (mm) L3-L4, L4-L5 and L5-S1
timeFrame: 10min after the infiltration
measure: Epidural space visibility L3-L4, L4-L5 and L5-S1: 0 for " no visibility ", 1 for " mild ", 2 for " good "
timeFrame: 10min after the infiltration
measure: Epidural space accessibility L3-L4, L4-L5 and L5-S1 : 0 for " no visibility ", 1 for " mild ", 2 for " good "
timeFrame: 10min after the infiltration
Other outcomes:
Locations:
city: Nantes
country: France
facility: University Hospital
Study officials:
affiliation: Nantes University Hospital
name: Benoit LE GOFF, Doctor
role: PRINCIPAL_INVESTIGATOR
References: