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

This study has been withdrawn prior to enrollment.
(Difficulty in recruiting patients for the study.)
Sponsor:
Information provided by (Responsible Party):
S. Tim Yoon, M.D., Emory University
ClinicalTrials.gov Identifier:
NCT00231374
First received: October 3, 2005
Last updated: January 8, 2014
Last verified: January 2014
  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

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • 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:
  • Safety measurements of one position over another.

Enrollment: 0
Study Start Date: September 2005
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00231374

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

Additional Information:
No publications provided

Responsible Party: S. Tim Yoon, M.D., Associate Professor, Emory University
ClinicalTrials.gov Identifier: NCT00231374     History of Changes
Other Study ID Numbers: 0489-2005
Study First Received: October 3, 2005
Last Updated: January 8, 2014
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 July 26, 2014