- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00403936
Effects of OA Decompression on the Autonomic Nervous System
February 24, 2010 updated by: Nova Southeastern University
Effects of OA Decompression on Activity of the Autonomic Nervous System
This study was designed to determine whether a simple manipulative technique of relaxing the tissues of the occipito-atlantal junction in the neck had any effect on the activity of the sympathetic or parasympathetic nervous system.
Subjects were dark adapted then measures of pupillary activity, reflecting autonomic nervous system activity were taken before and after treatment.
The study hypothesis was that thet treatment technique would have no effect on the pupillary measures, hence indicating no effect on autonomic system activity.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This study was a within subjects/crossover design in which each subject received the treatment and served as his/her own control.
100 subjects were recruited from the student/staff population of the university, were 18 y/o or older with no condition affecting pupillary activity.
Pupillary activity was measured with a PLR100 pupillometer and included pupillary diameter, pupillary response latency, maximum constriction velocity and maximum redilation velocity.
Subjects were adapted to a dim light environment, measures taken, treatment given at either third or fourth time period and measures retaken.
The study was approved by the NSU IRB.
Subject numbers were sufficient to have statistical power to find an effect.
The study found an effect of treatment on maximum size, showing a decrease with treatment.
Study Type
Interventional
Enrollment
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Florida
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Ft. Lauderdale, Florida, United States, 33328
- College of Osteopathic Med, Nova Southeastern Univ
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 18 y/o
- Normal accommodation and pupillary response
- Willing to undergo osteopathic manipulation
Exclusion Criteria:
- Active ocular or systemic disease
- Neurologic disease that would alter pupillary response
- Chronic pain syndromes of head or neck
- Pregnant
- Brain injury
- Taking medications that would alter autonomic tone
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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pupillary diameter
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pupillary latency
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pupillary constriction velocity
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pupillary redilation velocity
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Chris Piromalli, MSIII, College of Osteo Med, Nova Southeastern Univ
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2005
Study Completion
May 1, 2005
Study Registration Dates
First Submitted
November 22, 2006
First Submitted That Met QC Criteria
November 24, 2006
First Posted (Estimate)
November 27, 2006
Study Record Updates
Last Update Posted (Estimate)
February 25, 2010
Last Update Submitted That Met QC Criteria
February 24, 2010
Last Verified
February 1, 2010
More Information
Terms related to this study
Other Study ID Numbers
- OAdecompress1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.