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Radiation Exposure in Spine Intervention Under Angiography

NCT ID: NCT01751958

Last Updated: 2012-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2012-03-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Low Back Pain

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Epidural Steroid injection

Group-Epidural Steroid injection (Intermittent)

Group Type EXPERIMENTAL

Epidural steroid injection

Intervention Type RADIATION

Epidural steroid injection

Epidural Steroid Injection2

Group-injection under angiography (continuous)

Group Type EXPERIMENTAL

Epidural steroid injection

Intervention Type RADIATION

Epidural steroid injection

Interventions

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Epidural steroid injection

Epidural steroid injection

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

* Suspected of having radiculopathic low back pain

Exclusion Criteria

* Angiography is contraindicated
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Seoul National University Bundang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Suyoung Kim

Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Joon-woo Lee, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Bundang Hospital

Locations

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Joon-woo Lee

Seongnam-si, Gyeonggi-do, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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B-1105/128-014

Identifier Type: -

Identifier Source: org_study_id