NCT01751958

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for phase_3 low-back-pain

Timeline
Completed

Started Jul 2011

Shorter than P25 for phase_3 low-back-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 13, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 18, 2012

Completed
Last Updated

December 18, 2012

Status Verified

December 1, 2012

Enrollment Period

3 months

First QC Date

December 13, 2012

Last Update Submit

December 14, 2012

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (1)

  • Radiation dose

    Radiation dose of patients with spine invervention under angiography

    Treatment on the day

Study Arms (2)

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

Epidural steroid injectionRADIATION

Epidural steroid injection

Epidural Steroid Injection2Epidural Steroid injection

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Suspected of having radiculopathic low back pain

You may not qualify if:

  • Angiography is contraindicated

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Joon-woo Lee

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Joon-woo Lee, MD,PhD

    Seoul National University Bundang Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

December 13, 2012

First Posted

December 18, 2012

Study Start

July 1, 2011

Primary Completion

October 1, 2011

Study Completion

March 1, 2012

Last Updated

December 18, 2012

Record last verified: 2012-12

Locations

KR(1)