Back to resultsRadiation Exposure in Spine Intervention Under Angiography
Primary Purpose
Low Back Pain
Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Epidural steroid injection
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain
Eligibility Criteria
Inclusion Criteria:
- Suspected of having radiculopathic low back pain
Exclusion Criteria:
- Angiography is contraindicated
Sites / Locations
- Joon-woo Lee
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Epidural Steroid injection
Epidural Steroid Injection2
Arm Description
Group-Epidural Steroid injection (Intermittent)
Group-injection under angiography (continuous)
Outcomes
Primary Outcome Measures
Radiation dose
Radiation dose of patients with spine invervention under angiography
Secondary Outcome Measures
Full Information
NCT ID
NCT01751958
First Posted
December 13, 2012
Last Updated
December 14, 2012
Sponsor
Seoul National University Bundang Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01751958
Brief Title
Radiation Exposure in Spine Intervention Under Angiography
Official Title
Phase 3 Study of Evaluate Radiation Exposure and Procedure Times for Continuous Fluoroscopic Monitoring During Lumbar ESI
Study Type
Interventional
2. Study Status
Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
March 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Bundang Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Evaluate radiation exposure and procedure times for continuous fluoroscopic monitoring during lumbar ESI
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1000 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Epidural Steroid injection
Arm Type
Experimental
Arm Description
Group-Epidural Steroid injection (Intermittent)
Arm Title
Epidural Steroid Injection2
Arm Type
Experimental
Arm Description
Group-injection under angiography (continuous)
Intervention Type
Radiation
Intervention Name(s)
Epidural steroid injection
Intervention Description
Epidural steroid injection
Primary Outcome Measure Information:
Title
Radiation dose
Description
Radiation dose of patients with spine invervention under angiography
Time Frame
Treatment on the day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Suspected of having radiculopathic low back pain
Exclusion Criteria:
Angiography is contraindicated
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joon-woo Lee, MD,PhD
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Joon-woo Lee
City
Seongnam-si,
State/Province
Gyeonggi-do
ZIP/Postal Code
463-707
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Radiation Exposure in Spine Intervention Under Angiography
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