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Radiation Exposure in Spine Intervention Under Angiography

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01751958
First Posted: December 18, 2012
Last Update Posted: December 18, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Suyoung Kim, Seoul National University Bundang Hospital
  Purpose
Evaluate radiation exposure and procedure times for continuous fluoroscopic monitoring during lumbar ESI

Condition Intervention Phase
Low Back Pain Radiation: Epidural steroid injection Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 3 Study of Evaluate Radiation Exposure and Procedure Times for Continuous Fluoroscopic Monitoring During Lumbar ESI

Resource links provided by NLM:


Further study details as provided by Suyoung Kim, Seoul National University Bundang Hospital:

Primary Outcome Measures:
  • Radiation dose [ Time Frame: Treatment on the day ]
    Radiation dose of patients with spine invervention under angiography


Enrollment: 1000
Study Start Date: July 2011
Study Completion Date: March 2012
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Suspected of having radiculopathic low back pain

Exclusion Criteria:

  • Angiography is contraindicated
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01751958


Locations
Korea, Republic of
Joon-woo Lee
Seongnam-si,, Gyeonggi-do, Korea, Republic of, 463-707
Sponsors and Collaborators
Seoul National University Bundang Hospital
Investigators
Principal Investigator: Joon-woo Lee, MD,PhD Seoul National University Bundang Hospital
  More Information

Responsible Party: Suyoung Kim, Researcher, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT01751958     History of Changes
Other Study ID Numbers: B-1105/128-014
First Submitted: December 13, 2012
First Posted: December 18, 2012
Last Update Posted: December 18, 2012
Last Verified: December 2012

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms