Effect of Cranial Osteopathy on Visual Function

April 2, 2013 updated by: Mark Sandhouse, Nova Southeastern University
It is the purpose of this study to attempt to determine if there is an immediate, measurable change in visual function as a direct result following a session of cranial osteopathic manipulation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

29

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Ft. Lauderdale, Florida, United States, 33328
        • Nova Southeastern University Davie Health Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Free of active ocular or systemic disease
  • Refractive error between six diopters of myopia and five diopters of hyperopia with regular astigmatism of any amount
  • Normal best-corrected visual acuity at 20/40 or better
  • Normal amplitude of accommodation
  • Willing to undergo cranial osteopathic manipulation

Exclusion Criteria:

  • Pregnancy
  • History of previous closed head trauma or brain injury
  • Students from the Nova Southeastern University Colleges of Osteopathic Medicine and Optometry
  • Prior cranial manipulative treatment/craniosacral therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Assessment for cranial strain patterns, followed by indirect osteopathic treatment of dysfunctions found on assessment, followed by reassessment.
Procedure: Cranial osteopathic manipulation
This treatment is performed by exaggerating the motion asymmetry with a minimum of pressure (a few ounces) and holding the position until the motion becomes symmetrical.
Sham Comparator: 2
Assessment for cranial strain patterns, followed by laying on of hands, followed by reassessment.
Procedure: Sham/Placebo
A laying on of hands with no treatment being performed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Accommodative system testing Visual acuity testing Stereoacuity testing Vergence system testing Pupillary testing
Time Frame: Immediately after intervention.
Immediately after intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nova Southeastern University

Investigators

  • Principal Investigator: Mark Sandhouse, D.O., Nova Southeastern University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2001

Study Completion (Actual)

February 1, 2002

Study Registration Dates

First Submitted

August 1, 2007

First Submitted That Met QC Criteria

August 1, 2007

First Posted (Estimate)

August 2, 2007

Study Record Updates

Last Update Posted (Estimate)

April 4, 2013

Last Update Submitted That Met QC Criteria

April 2, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HPD-COM 06200101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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