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

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Emory University

Status

Withdrawn

Conditions

Back Pain

Treatments

Procedure: Myelogram

Study type

Interventional

Funder types

Other

Identifiers

NCT00231374
0489-2005

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18 to 64 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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