Epidural Contrast Flow Patterns of TESI Using the Inferior-Anterior Position as the Final Needle Tip Position.

Terminated

• Conditions: Lumbar Herniated Nucleus Pulposus; Lumbosacral Radiculopathy

• Registration Number: NCT01836770
• Lead Sponsor: George Washington University

Brief Summary

The purpose of this study is to describe the contrast flow patterns in the epidural space using the inferior-anterior approach with continuous fluoroscopic guidance, and determine how well this approach correlates with appropriate contrast flow patterns and with analgesia at follow up. This knowledge may prove useful in guiding physician practice patterns in the non-surgical management of low back pain.

Hypothesis: The investigators hypothesize that there will be suitable (ventral/anterior) epidural contrast spread based on inferior-anterior needle-tip position, particularly with appropriate needle tip position.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2013-01-07
• Study First Submitted QC: 2013-04-17
• Study First Posted: 2013-04-22
• Primary Completion: 2013-06-20
• Study Completion: 2013-06-20
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-01
• Last Update Posted: 2018-03-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

• 18 years of age or older
• History of lumbosacral radiculopathy or lumbar herniated nucleus pulposus
• Scheduled for TFESI at GW Spine and Pain Center

Exclusion Criteria

• Pregnant or plan on becoming pregnant
• Have undergone TFESI in the past year
• Opioid habituation
• Lumbo-sacral stenosis
• Lumbar surgery
• Lumbar spondylolisthesis

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Contrast flow patterns	3 Months	Contrast flow patterns will be used as the primary outcome measure. The statistical test to be employed is to compare the proportions of patients in the study who experienced posterior flow, anterior flow and if that anterior flow had spread to more than 1 vertebral level in either direction, what that direction was, and the presence or absence of vascular flow.

Secondary Outcome Measures

Name	Time	Method
VAS pain score	3 months	VAS Pain Score - The statistical test to be employed is Wilcoxon Signed Rank Test to compare if there is a difference in pain score at appointments 1 months and 3 months post-injection relative to pre-injection.

Trial Locations

Locations (1)

George Washington Spine and Pain Center; 🇺🇸 Washington, District of Columbia, United States