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.
Verified date | March 2018 |
Source | George Washington University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | George Washington Spine and Pain Center | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
George Washington University |
United States,
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 |
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