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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01836770
Other study ID # Kambin
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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