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

Not Applicable

Completed

• Conditions: Lumbar Radiculopathy Due to Spinal Nerve Compression
• Interventions: Procedure: Fluoroscopically Guided Lumbar Transforaminal Epidural Injections; Procedure: conventional manner

• Registration Number: NCT03341182
• Lead Sponsor: Yonsei University

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

1. A planned Fluoroscopically Guided Lumbar Transforaminal Epidural Injection should be performed after receiving the informed consent of the patient.

2. This study is single-blind because it is not possible to blind the practitioner performing the injection.

3. 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.

4. 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

Study Timeline

• Study First Submitted: 2017-10-25
• Study First Submitted QC: 2017-11-09
• Study First Posted: 2017-11-14
• Study Start: 2017-12-21
• Primary Completion: 2018-08-21
• Study Completion: 2018-08-21
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-17
• Last Update Posted: 2019-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
mirror use group (group B)	Fluoroscopically Guided Lumbar Transforaminal Epidural Injections	A mirror is used in tunnel view technique
normal method group (group A)	conventional manner	A mirror is not used in tunnel view technique (conventional manner)

Primary Outcome Measures

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

Trial Locations

Locations (1)

Dept. of Anesthesiology and Pain Medicine, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of