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

Back Pain Clinical Trial

Official title:

In Vivo Analysis of Intradural Pressure Variation With Patient Positioning

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00231374
• Other study ID #: 0489-2005
• Status: Withdrawn
• Phase: N/A
• First received: October 3, 2005
• Last updated: January 8, 2014
• Start date: September 2005
• Est. completion date: September 2007

Study information

• Verified date: January 2014
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Back Pain

Intervention

Procedure:
• Myelogram

Locations

Country	Name	City	State
United States	Emory Orthopaedics & Spine Center	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CSF pressure measurements on 5 patients having a cervical myelogram in 3 positions.
Primary	CSF pressure measurements on 5 patients having a lumbar myelogram in 2 positions.
Secondary	Safety measurements of one position over another.

External Links

•   Departmental web site