Epidural Contrast Flow Patterns of TESI Using the Inferior-Anterior Position as the Final Needle Tip Position.
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|ClinicalTrials.gov Identifier: NCT01836770|
Recruitment Status : Terminated (lack of enrollment; terminated by the Principal Investigator)
First Posted : April 22, 2013
Last Update Posted : March 5, 2018
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.
|Condition or disease|
|Lumbosacral Radiculopathy Lumbar Herniated Nucleus Pulposus|
|Study Type :||Observational|
|Actual Enrollment :||5 participants|
|Official Title:||Epidural Contrast Flow Patterns of Transforaminal Epidural Steroid Injections Using the Inferior-Anterior Position as the Final Needle Tip Position.|
|Actual Study Start Date :||August 2010|
|Actual Primary Completion Date :||June 20, 2013|
|Actual Study Completion Date :||June 20, 2013|
Transforaminal Epidural Steroid Injection
Patients with a history of lumbosacral radiculopathy or lumbar herniated nucleus pulposus, scheduled for Transforaminal Epidural Steroid Injection.
- Contrast flow patterns [ Time Frame: 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.
- VAS pain score [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01836770
|United States, District of Columbia|
|George Washington Spine and Pain Center|
|Washington, District of Columbia, United States, 20037|
|Principal Investigator:||Mehul J Desai, MD MPH||George Washington Spine and Pain Center|