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

Lumbosacral Radiculopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01836770
• Other study ID #: Kambin
• Status: Terminated
• Phase: N/A
• First received: January 7, 2013
• Last updated: March 1, 2018
• Start date: August 2010
• Est. completion date: June 20, 2013

Study information

• Verified date: March 2018
• Source: George Washington University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: June 20, 2013
• Est. primary completion date: June 20, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lumbar Herniated Nucleus Pulposus
• Lumbosacral Radiculopathy
• Radiculopathy

Locations

Country	Name	City	State
United States	George Washington Spine and Pain Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
George Washington University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Contrast flow patterns	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.	3 Months
Secondary	VAS pain score	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.	3 months