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OpenTrials
Completed

NCT Number: NCT04634955

S1 Transforaminal Injection and Vascular Incidence

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.

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Key information

Age range

20 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hong ji HEE

Daegu, 42601, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • coagulopathy
  • infection

Treatment and study plan

tranforaminal epidural injection

Procedure

tranforaminal epidural injection which is performed by fluoroscopic guidance

Primary outcomes

  1. intravascular incidence

    Time frame: 15 minutes after the completion of the intervention

    intravascular injection rate

Secondary outcomes

  1. procedure time

    Time frame: 15 minutes after the completion of the intervention

    procedure time

  2. radiation dose

    Time frame: 15 minutes after the completion of the intervention

    radiation dose

Sponsors and collaborators

Lead sponsor

Keimyung University Dongsan Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 18, 2020
Registry last updated
Dec 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.