Radiation Exposure in Spine Intervention Under Angiography

December 14, 2012 updated by: Suyoung Kim, Seoul National University Bundang Hospital

Phase 3 Study of Evaluate Radiation Exposure and Procedure Times for Continuous Fluoroscopic Monitoring During Lumbar ESI

Evaluate radiation exposure and procedure times for continuous fluoroscopic monitoring during lumbar ESI

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The purpose of this prospective study was to evaluate radiation exposure and procedure times for fluoroscopic monitoring during lumbar ESI with analyzing the differences among operators (experienced staff and trainee) and among different method for ESI.

Study Type

Interventional

Enrollment (Actual)

1000

Phase

  • Phase 3

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

  • Korea, Republic of
    • Gyeonggi-do
      • Seongnam-si,, Gyeonggi-do, Korea, Republic of, 463-707
        • Joon-woo Lee

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

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Suspected of having radiculopathic low back pain

Exclusion Criteria:

  • Angiography is contraindicated

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Epidural Steroid injection
Group-Epidural Steroid injection (Intermittent)
Radiation: Epidural steroid injection
Epidural steroid injection
Experimental: Epidural Steroid Injection2
Group-injection under angiography (continuous)
Radiation: Epidural steroid injection
Epidural steroid injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiation dose
Time Frame: Treatment on the day
Radiation dose of patients with spine invervention under angiography
Treatment on the day

Collaborators and Investigators

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

Sponsor

Seoul National University Bundang Hospital

Investigators

  • Principal Investigator: Joon-woo Lee, MD,PhD, Seoul National University Bundang Hospital

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

July 1, 2011

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

December 13, 2012

First Submitted That Met QC Criteria

December 14, 2012

First Posted (Estimate)

December 18, 2012

Study Record Updates

Last Update Posted (Estimate)

December 18, 2012

Last Update Submitted That Met QC Criteria

December 14, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B-1105/128-014

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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