Effects of OA Decompression on the Autonomic Nervous System

This study has been completed.
Sponsor:
Information provided by:
Nova Southeastern University
ClinicalTrials.gov Identifier:
NCT00403936
First received: November 22, 2006
Last updated: February 24, 2010
Last verified: February 2010
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind
Primary Purpose: Treatment
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

ClinicalTrials.gov Identifier: NCT00403936     History of Changes
Other Study ID Numbers: OAdecompress1
Study First Received: November 22, 2006
Last Updated: February 24, 2010
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 19, 2014