Radiation Exposure in Spine Intervention Under Angiography | NCT01751958

Studies
Radiation Exposure in Spine Intervention Under Angiography

NCT01751958

Sponsor

Seoul National University Bundang Hospital

Status

Completed

Last Update Posted

Dec 18, 2012Estimated

Enrollment

1,000Actual

Phase

Phase 3

Conditions

Low Back Pain

Interventions

Epidural steroid injection

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2011

Primary Completion Date

Oct 2011Actual

Completion Date

Mar 2012Actual

First Submitted Date

Dec 13, 2012

First Submission Date that Met QC Criteria

Dec 14, 2012

First Posted Date

Dec 18, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 14, 2012

Last Update Posted Date

Dec 18, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Suyoung Kim, Researcher, Seoul National University Bundang HospitalPrincipal Investigator

Lead Sponsor

Seoul National University Bundang HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Epidural Steroid injection	Experimental	Group-Epidural Steroid injection (Intermittent)	Radiation: Epidural steroid injection
Epidural Steroid Injection2	Experimental	Group-injection under angiography (continuous)	Radiation: Epidural steroid injection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Epidural steroid injection	Radiation	Epidural steroid injection	Epidural Steroid Injection2 Epidural Steroid injection

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Suspected of having radiculopathic low back pain

Exclusion Criteria:

Angiography is contraindicated

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Joon-woo Lee, MD,PhD	Seoul National University Bundang Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Joon-woo Lee		Seongnam-si	Gyeonggi-do	463-707	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D017116	Low Back Pain

Ancestor Terms

ID	Term
D001416	Back Pain
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided