Measure of Cerebrospinal Fluid (CSF) Pressure Variation With Patient Positioning
Recruitment status was Recruiting
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Back Pain |
Procedure: Myelogram |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | In Vivo Analysis of Intradural Pressure Variation With Patient Positioning |
- 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.
- Safety measurements of one position over another.
| Estimated Enrollment: | 10 |
| Study Start Date: | September 2005 |
| Estimated Study Completion Date: | September 2006 |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 64 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| Contact: Tim Yoon, M.D. | 404-778-7000 |
| United States, Georgia | |
| Emory Orthopaedics & Spine Center | Recruiting |
| Atlanta, Georgia, United States, 30329 | |
| Contact: S Radek, BS 404-778-7000 | |
| Sub-Investigator: John G Heller, M.D. | |
| Principal Investigator: | Tim Yoon, M.D. | Emory University |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00231374 History of Changes |
| Other Study ID Numbers: | 489-2005 |
| Study First Received: | October 3, 2005 |
| Last Updated: | January 26, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Emory University:
|
cerebrospinal fluid pain in cervical spine pain in lumbar spine myelogram |
Additional relevant MeSH terms:
|
Back Pain Pain Neurologic Manifestations Nervous System Diseases Signs and Symptoms |
ClinicalTrials.gov processed this record on June 18, 2013