Measure of Cerebrospinal Fluid (CSF) Pressure Variation With Patient Positioning

Study Overview
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Brief Summary
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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
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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.

Official Title
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In Vivo Analysis of Intradural Pressure Variation With Patient Positioning

Conditions
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Back Pain

Intervention / Treatment
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* Procedure: Myelogram


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Myelogram|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety measurements of one position over another. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cerebrospinal fluid, pain in cervical spine, pain in lumbar spine, myelogram