S1 Transforaminal Injection and Vascular Incidence

December 18, 2022 updated by: Ji Hee Hong, Keimyung University Dongsan Medical Center

Comparison of Intravascular Incidence With Different Fluoroscopic Approach Method During S1 Trasnforaminal Injection

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

149

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 81 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • coagulopathy
  • infection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: S1 transforaminal injection with oboique view
S1 transforaminal injection with oblique fluoroscopic view
Procedure: tranforaminal epidural injection
tranforaminal epidural injection which is performed by fluoroscopic guidance
Active Comparator: S1 transforaminal injection with AP view
S1 transforaminal injection with anteroposterior fluoroscopic view
Procedure: tranforaminal epidural injection
tranforaminal epidural injection which is performed by fluoroscopic guidance

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
intravascular incidence
Time Frame: 15 minutes after the completion of the intervention
intravascular injection rate
15 minutes after the completion of the intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
procedure time
Time Frame: 15 minutes after the completion of the intervention
procedure time
15 minutes after the completion of the intervention
radiation dose
Time Frame: 15 minutes after the completion of the intervention
radiation dose
15 minutes after the completion of the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Keimyung University Dongsan Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2020

Primary Completion (Actual)

April 15, 2021

Study Completion (Actual)

April 30, 2021

Study Registration Dates

First Submitted

November 10, 2020

First Submitted That Met QC Criteria

November 16, 2020

First Posted (Actual)

November 18, 2020

Study Record Updates

Last Update Posted (Actual)

December 20, 2022

Last Update Submitted That Met QC Criteria

December 18, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2020-08-028

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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