Effects of OA Decompression on the Autonomic Nervous System - Full Text View

Sponsored by:	Nova Southeastern University
Information provided by:	Nova Southeastern University
ClinicalTrials.gov Identifier:	NCT00403936

Purpose

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.

Condition	Intervention
Muscle Tension	Procedure: OA decompression manipulation

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Active Control, Crossover Assignment, Efficacy Study
Official Title:	Effects of OA Decompression on Activity of the Autonomic Nervous System

Further study details as provided by Nova Southeastern University:

Primary Outcome Measures:

pupillary diameter
pupillary latency
pupillary constriction velocity
pupillary redilation velocity

Estimated Enrollment:	100
Study Start Date:	April 2005
Estimated Study Completion Date:	May 2005

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00403936

Locations

United States, Florida
College of Osteopathic Med, Nova Southeastern Univ
Ft. Lauderdale, Florida, United States, 33328

Sponsors and Collaborators

Nova Southeastern University

Investigators

Principal Investigator:

Chris Piromalli, MSIII

College of Osteo Med, Nova Southeastern Univ

More Information

Study ID Numbers:	OAdecompress1
Study First Received:	November 22, 2006
Last Updated:	November 24, 2006
ClinicalTrials.gov Identifier:	NCT00403936
Health Authority:	United States: Institutional Review Board

Keywords provided by Nova Southeastern University:

osteopathic manipulation
autonomic nervous system

ClinicalTrials.gov processed this record on January 14, 2009