Measure of Cerebrospinal Fluid (CSF) Pressure Variation With Patient Positioning
Primary Purpose
Back Pain
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Myelogram
Sponsored by
About this trial
This is an interventional prevention trial for Back Pain focused on measuring cerebrospinal fluid, pain in cervical spine, pain in lumbar spine, myelogram
Eligibility Criteria
Inclusion Criteria: Need a lumbar or cervical myelogram as part of routine care. Exclusion Criteria: Not needing a myelogram in the cervical or lumbar spine.
Sites / Locations
- Emory Orthopaedics & Spine Center
Outcomes
Primary Outcome Measures
CSF pressure measurements on 5 patients having a cervical myelogram in 3 positions.
CSF pressure measurements on 5 patients having a lumbar myelogram in 2 positions.
Secondary Outcome Measures
Safety measurements of one position over another.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00231374
Brief Title
Measure of Cerebrospinal Fluid (CSF) Pressure Variation With Patient Positioning
Official Title
In Vivo Analysis of Intradural Pressure Variation With Patient Positioning
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Withdrawn
Why Stopped
Difficulty in recruiting patients for the study.
Study Start Date
September 2005 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
September 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
4. Oversight
5. Study Description
Brief Summary
This is a study looking at pressure changes in the fluid that surrounds the spine when a person is positioned in 2-3 different ways.
Detailed Description
Volunteers who need a myelogram of their spine as part of their routine medical care are being asked to be in this study. A myelogram is an imaging study with x-rays after an agent is put into the spine that shows spinal fluid on the x-ray. It requires insertion of a needle into the cerebrospinal fluid (CSF) inside the spine. CSF is a bodily fluid that bathes the brain, spinal cord, and nerve roots. This study is being conducted to measure CSF pressure changes with different patient positioning.
We are motivated to do this research study to better treat patients who develop a spinal fluid leak during a myelogram or other spine procedure. The tissue that holds the cerebrospinal fluid (CSF) is called the dura. During surgery or other procedures, the dura can develop a tear. Dural tears can result in a leakage of CSF. CSF leaks are a recognized complication of spinal surgery. Currently, there is no evidence on whether or not a specific postoperative spine position is beneficial, especially for cervical (neck spine) CSF leaks. The process of dural healing after a dural tear is influenced by CSF pressure. High CSF pressure may inhibit dural healing. We want to find the patient position (sitting, lying down, or reclining) that reduces the CSF pressure the most. To do this, we want to attach a pressure monitor to the needle that is normally placed in the spine for a myelogram and measure the CSF pressure.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Back Pain
Keywords
cerebrospinal fluid, pain in cervical spine, pain in lumbar spine, myelogram
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Myelogram
Primary Outcome Measure Information:
Title
CSF pressure measurements on 5 patients having a cervical myelogram in 3 positions.
Title
CSF pressure measurements on 5 patients having a lumbar myelogram in 2 positions.
Secondary Outcome Measure Information:
Title
Safety measurements of one position over another.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Need a lumbar or cervical myelogram as part of routine care.
Exclusion Criteria:
Not needing a myelogram in the cervical or lumbar spine.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tim Yoon, M.D.
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory Orthopaedics & Spine Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.emoryhealthcare.org/emory-orthopaedics-spine-hospital/index.html
Description
Departmental web site
Learn more about this trial
Measure of Cerebrospinal Fluid (CSF) Pressure Variation With Patient Positioning
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