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The Effects of Use of Mirror Image on Radiation Exposure During Fluoroscopically Guided Transforaminal Epidural Injection

Primary Purpose

Lumbar Radiculopathy Due to Spinal Nerve Compression

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Fluoroscopically Guided Lumbar Transforaminal Epidural Injections
conventional manner
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Lumbar Radiculopathy Due to Spinal Nerve Compression focused on measuring epidural steroid injection, radiation exposure, mirror

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

1. Magnetic resonance imaging (MRI) and clinical manifestations of adult men and women over 20 years of age are eligible for radiculopathy due to back nerve root compression and subject to fluoroscopically guided lumbar transforaminal epidural Injection at the suspected spinal nerveroots level.

Exclusion Criteria:

  1. Blood clotting disorder
  2. Infection around the site
  3. Contrast agent allergy
  4. Uncontrolled cardiovascular, cerebrovascular, kidney disease
  5. Past history of spinal surgery (ex, spinal fusion)
  6. If can not block due to Non-cooperation with subjects (ex, if you can not take the stomach)
  7. Patients taking narcotic analgesics

Sites / Locations

  • Dept. of Anesthesiology and Pain Medicine, Yonsei University College of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

normal method group (group A)

mirror use group (group B)

Arm Description

A mirror is not used in tunnel view technique (conventional manner)

A mirror is used in tunnel view technique

Outcomes

Primary Outcome Measures

radiation exposure time(second)
In both groups, overall procedure time recorded on the monitor is recorded after the procedure is over.

Secondary Outcome Measures

Full Information

First Posted
October 25, 2017
Last Updated
January 17, 2019
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT03341182
Brief Title
The Effects of Use of Mirror Image on Radiation Exposure During Fluoroscopically Guided Transforaminal Epidural Injection
Official Title
The Effects of Use of Mirror Image on Radiation Exposure During Fluoroscopically Guided Transforaminal Epidural Injection
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
December 21, 2017 (Actual)
Primary Completion Date
August 21, 2018 (Actual)
Study Completion Date
August 21, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Lumbar Transforaminal Epidural Injection is helpful for the treatment of lumbosacral radicular pain. Tunnel view technique is the basis of X-ray assisted intervention. In this technique, it is necessary to handle the block needle in order to adjust the direction of needle to the tunnel view toward target. If a mirror is used during needle handling, overall procedure time and radiation exposure can be reduced.
Detailed Description
A planned Fluoroscopically Guided Lumbar Transforaminal Epidural Injection should be performed after receiving the informed consent of the patient. This study is single-blind because it is not possible to blind the practitioner performing the injection. Subjects were randomly assigned to the normal method group (group A) and the mirror use group (group B) by a random random number table, and the possibilities for belonging to any group were all the same and can not be artificially controlled by researchers. After the procedure, a resident who does not know of this study records the radiation exposure time displayed on the monitor and the overall procedure time

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Radiculopathy Due to Spinal Nerve Compression
Keywords
epidural steroid injection, radiation exposure, mirror

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
normal method group (group A) mirror use group (group B)
Masking
ParticipantInvestigator
Masking Description
The subjects were randomly assigned to normal method group (group A) and mirror use group (group B), and the assigned results are unknown. The Outcomes Assessor is not related to the study, and does not know its contents.
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
normal method group (group A)
Arm Type
Active Comparator
Arm Description
A mirror is not used in tunnel view technique (conventional manner)
Arm Title
mirror use group (group B)
Arm Type
Experimental
Arm Description
A mirror is used in tunnel view technique
Intervention Type
Procedure
Intervention Name(s)
Fluoroscopically Guided Lumbar Transforaminal Epidural Injections
Intervention Description
Lay the subject down on the stomach and hold the pillow on the stomach. The skin of the injection area is sterilized by aseptic method and covered with aseptic pouch. After confirming the level of he vertebrae around the C-arm and aligning the anteroposterior view of the endplate of the vertebral body, rotate the C-arm 20~30 degrees diagonally in the direction to be performed. After confirming the best Scotty dog view, confirm the final target point at 6 o'clock directly below the pedicle. At this position, the skin point is marked on the skin. And then both groups proceed in parallel with the beam direction of the transducer with the tunnel view technique until the needle reaches the back of the vertebral body at the level of the spinal nerve roots. At this time group A uses a mirror and group B dose not. The final reach of the target point (ideal depth) is confirmed through the anterior and posterior views and lateral views.
Intervention Type
Procedure
Intervention Name(s)
conventional manner
Intervention Description
A portable mirror is located at the side of surgical table and used in this procedure.
Primary Outcome Measure Information:
Title
radiation exposure time(second)
Description
In both groups, overall procedure time recorded on the monitor is recorded after the procedure is over.
Time Frame
Immediately after the procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1. Magnetic resonance imaging (MRI) and clinical manifestations of adult men and women over 20 years of age are eligible for radiculopathy due to back nerve root compression and subject to fluoroscopically guided lumbar transforaminal epidural Injection at the suspected spinal nerveroots level. Exclusion Criteria: Blood clotting disorder Infection around the site Contrast agent allergy Uncontrolled cardiovascular, cerebrovascular, kidney disease Past history of spinal surgery (ex, spinal fusion) If can not block due to Non-cooperation with subjects (ex, if you can not take the stomach) Patients taking narcotic analgesics
Facility Information:
Facility Name
Dept. of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effects of Use of Mirror Image on Radiation Exposure During Fluoroscopically Guided Transforaminal Epidural Injection

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