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

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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01836770

Enrollment

Registered

2013-04-22

Start date

2010-08-31

Completion date

2013-06-20

Last updated

2018-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lumbar Herniated Nucleus Pulposus, Lumbosacral Radiculopathy

Keywords

Transforaminal Epidural Steroid Injections

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

United States

Outcome results