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

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ClinicalTrials.gov Identifier: NCT01832844
Recruitment Status : Completed
First Posted : April 16, 2013
Last Update Posted : March 24, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease Intervention/treatment
Sciatica Procedure: Group " with scan prior to infiltration " Procedure: Group " without scan "

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Official Title: Effects of Scan Control for Presumed Difficult Epidural Infiltrations: a Monocentric, Prospective, Randomized, Controlled, Simple Blind Trial
Study Start Date : April 2013
Primary Completion Date : January 2014
Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Group " with scan prior to infiltration " Procedure: 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
Placebo Comparator: Group " without scan "
Patients will have a "dummy" lumber spine evaluation in order to put patients in blind conditions
Procedure: Group " without scan "


Outcome Measures

Primary Outcome Measures :
  1. Visual analogue scale measuring the pain during infiltration [ Time Frame: 10min after the infiltration ]
    To evaluate if scan prior to epidural infiltration could improve its tolerance


Secondary Outcome Measures :
  1. Infiltration evaluation: procedure time between skin passage and release of the needle [ Time Frame: 10min after the infiltration ]
  2. Infiltration evaluation: attempts number before correct positioning of needle [ Time Frame: 10min after the infiltration ]
  3. Infiltration evaluation: number of puncture sites [ Time Frame: 10min after the infiltration ]
  4. Infiltration evaluation: number of failures [ Time Frame: 10min after the infiltration ]
  5. Infiltration tolerance : VAS for pain (graduating from 0 to 10) [ Time Frame: 48 hours ]
  6. Infiltration tolerance : infiltration complications (headaches, pain at the puncture site, other) [ Time Frame: 48 hours ]
  7. Distance skin- épidural space (mm) L3-L4, L4-L5 and L5-S1 [ Time Frame: 10min after the infiltration ]
  8. Minimal interspinous distance (mm) L3-L4, L4-L5 and L5-S1 [ Time Frame: 10min after the infiltration ]
  9. Epidural space visibility L3-L4, L4-L5 and L5-S1: 0 for " no visibility ", 1 for " mild ", 2 for " good " [ Time Frame: 10min after the infiltration ]
  10. Epidural space accessibility L3-L4, L4-L5 and L5-S1 : 0 for " no visibility ", 1 for " mild ", 2 for " good " [ Time Frame: 10min after the infiltration ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01832844


Locations
France
University Hospital
Nantes, France, 44000
Sponsors and Collaborators
Nantes University Hospital
Investigators
Principal Investigator: Benoit LE GOFF, Doctor Nantes University Hospital
More Information

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT01832844     History of Changes
Other Study ID Numbers: RC13_0096
First Posted: April 16, 2013    Key Record Dates
Last Update Posted: March 24, 2014
Last Verified: March 2014

Keywords provided by Nantes University Hospital:
Scan control
Epidural infiltration
visual analogue scale (VAS)

Additional relevant MeSH terms:
Sciatica
Neuralgia
Pain
Neurologic Manifestations
Nervous System Diseases
Sciatic Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms