Effects of OA Decompression on the Autonomic Nervous System

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00403936
Recruitment Status : Completed
First Posted : November 27, 2006
Last Update Posted : February 25, 2010
Information provided by:
Nova Southeastern University

Brief Summary:
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 or disease Intervention/treatment Phase
Muscle Tension Procedure: OA decompression manipulation Not Applicable

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  (Clinical Trial)
Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Effects of OA Decompression on Activity of the Autonomic Nervous System
Study Start Date : April 2005
Study Completion Date : May 2005

Primary Outcome Measures :
  1. pupillary diameter
  2. pupillary latency
  3. pupillary constriction velocity
  4. pupillary redilation velocity

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00403936

United States, Florida
College of Osteopathic Med, Nova Southeastern Univ
Ft. Lauderdale, Florida, United States, 33328
Sponsors and Collaborators
Nova Southeastern University
Principal Investigator: Chris Piromalli, MSIII College of Osteo Med, Nova Southeastern Univ Identifier: NCT00403936     History of Changes
Other Study ID Numbers: OAdecompress1
First Posted: November 27, 2006    Key Record Dates
Last Update Posted: February 25, 2010
Last Verified: February 2010

Keywords provided by Nova Southeastern University:
osteopathic manipulation
autonomic nervous system