S1 Transforaminal Injection and Vascular Incidence

NCT ID: NCT04634955

Last Updated: 2022-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

149 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-15

Study Completion Date

2021-04-30

Brief Summary

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Intravascular incidence during S1 transforaminal injection is known to be higher than lumbar injection. Its incidence is reported to be 15\~25%.

This study was aimed to see if there is any benefit of reducing the intravasuclar injection rate when S1 transforaminal injection was performed by different fluorosopic approach.

Detailed Description

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Fluorosocpically guided transforaminal epidural steroid injection is a popular interventional procedure that is effective in radicular pain conditions such as herniated interverebral disc, spinal stenosis and failed back surgery syndrome.

The incidence of inadvertent intravascular needle injection during lumbar transforaminal injection is reported as from 9.9% to 30.8%. In particular, S1 intravascular injection rate is more frequent than at the lumbar level.

Previous study reported that guiding the needle toward the S1 foramen using the S1 scotty dog image as a bony landmark, not in the classic way, but in an oblique fluoroscopic view, during L5 and S1 transforaminal epidural steroid injection, can save procedure time and reduce the risk of radiation exposure.

In this stidy, the investigators aimed to compare the incidence of intravascular injection rate by anteroposterior and oblique view approaches for S1 transforaminal epidural steroid injection. In addition, the investigators also compared the procedure time and radiation exposure between two approach method.

Conditions

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Inadvertent Arterial Puncture

Keywords

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intravascular injection transforaminal injection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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S1 transforaminal injection with oboique view

S1 transforaminal injection with oblique fluoroscopic view

Group Type ACTIVE_COMPARATOR

tranforaminal epidural injection

Intervention Type PROCEDURE

tranforaminal epidural injection which is performed by fluoroscopic guidance

S1 transforaminal injection with AP view

S1 transforaminal injection with anteroposterior fluoroscopic view

Group Type ACTIVE_COMPARATOR

tranforaminal epidural injection

Intervention Type PROCEDURE

tranforaminal epidural injection which is performed by fluoroscopic guidance

Interventions

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tranforaminal epidural injection

tranforaminal epidural injection which is performed by fluoroscopic guidance

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* spinal stenosis
* herniated intervertebral disc
* failed back surgery syndrome

Exclusion Criteria

* coagulopathy
* infection
Minimum Eligible Age

20 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Keimyung University Dongsan Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Ji Hee Hong

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ji Hee Hong, PhD

Role: PRINCIPAL_INVESTIGATOR

Keimyung University

Locations

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Hong ji HEE

Daegu, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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2020-08-028

Identifier Type: -

Identifier Source: org_study_id