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

NCT ID: NCT00231374

Last Updated: 2014-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2007-09-30

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.

Conditions

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Back Pain

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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Myelogram

Intervention Type PROCEDURE

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Emory University

OTHER

Sponsor Role lead

Responsible Party

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S. Tim Yoon, M.D.

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tim Yoon, M.D.

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

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Emory Orthopaedics & Spine Center

Atlanta, Georgia, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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0489-2005

Identifier Type: -

Identifier Source: org_study_id

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