NCT00403936

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2005

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2005

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

November 22, 2006

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 27, 2006

Completed
Last Updated

February 25, 2010

Status Verified

February 1, 2010

First QC Date

November 22, 2006

Last Update Submit

February 24, 2010

Conditions

Muscle Tension

Keywords

osteopathic manipulationautonomic nervous system

Outcome Measures

Primary Outcomes (4)

  • pupillary diameter

  • pupillary latency

  • pupillary constriction velocity

  • pupillary redilation velocity

Interventions

OA decompression manipulationPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • y/o
  • Normal accommodation and pupillary response
  • Willing to undergo osteopathic manipulation

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

College of Osteopathic Med, Nova Southeastern Univ

Fort Lauderdale, Florida, 33328, United States

Location

Study Officials

  • Chris Piromalli, MSIII

    College of Osteo Med, Nova Southeastern Univ

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 22, 2006

First Posted

November 27, 2006

Study Start

April 1, 2005

Study Completion

May 1, 2005

Last Updated

February 25, 2010

Record last verified: 2010-02

Locations

US(1)