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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00231374
Recruitment Status : Withdrawn (Difficulty in recruiting patients for the study.)
First Posted : October 4, 2005
Last Update Posted : January 9, 2014
Information provided by (Responsible Party):
S. Tim Yoon, M.D., Emory University

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.

Condition or disease Intervention/treatment Phase
Back Pain Procedure: Myelogram Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: In Vivo Analysis of Intradural Pressure Variation With Patient Positioning
Study Start Date : September 2005
Actual Primary Completion Date : September 2007
Actual Study Completion Date : September 2007

Primary Outcome Measures :
  1. CSF pressure measurements on 5 patients having a cervical myelogram in 3 positions.
  2. CSF pressure measurements on 5 patients having a lumbar myelogram in 2 positions.

Secondary Outcome Measures :
  1. Safety measurements of one position over another.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00231374

United States, Georgia
Emory Orthopaedics & Spine Center
Atlanta, Georgia, United States, 30329
Sponsors and Collaborators
Emory University
Principal Investigator: Tim Yoon, M.D. Emory University

Additional Information:
Responsible Party: S. Tim Yoon, M.D., Associate Professor, Emory University Identifier: NCT00231374     History of Changes
Other Study ID Numbers: 0489-2005
First Posted: October 4, 2005    Key Record Dates
Last Update Posted: January 9, 2014
Last Verified: January 2014

Keywords provided by S. Tim Yoon, M.D., Emory University:
cerebrospinal fluid
pain in cervical spine
pain in lumbar spine

Additional relevant MeSH terms:
Back Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms