Back Pain Clinical Trial
Official title:
In Vivo Analysis of Intradural Pressure Variation With Patient Positioning
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.
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.
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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