Effects of OA Decompression on the Autonomic Nervous System

NCT ID: NCT00403936

Last Updated: 2010-02-25

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

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-30

Study Completion Date

2005-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Muscle Tension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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OA decompression manipulation

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Nova Southeastern University

OTHER

Sponsor Role lead

Principal Investigators

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Chris Piromalli, MSIII

Role: PRINCIPAL_INVESTIGATOR

College of Osteo Med, Nova Southeastern Univ

Locations

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College of Osteopathic Med, Nova Southeastern Univ

Fort Lauderdale, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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OAdecompress1

Identifier Type: -

Identifier Source: org_study_id

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