Radiation Exposure in Spine Intervention Under Angiography

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Suyoung Kim, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier:
NCT01751958
First received: December 13, 2012
Last updated: December 14, 2012
Last verified: December 2012
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Seoul National University Bundang Hospital:

Primary Outcome Measures:
  • Radiation dose [ Time Frame: Treatment on the day ] [ Designated as safety issue: No ]
    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
Other Name: Epidural steroid injection
Experimental: Epidural Steroid Injection2
Group-injection under angiography (continuous)
Radiation: Epidural steroid injection
Epidural steroid injection
Other Name: 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

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Suspected of having radiculopathic low back pain

Exclusion Criteria:

  • Angiography is contraindicated
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: December 13, 2012
Last Updated: December 14, 2012
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on July 20, 2014