Effect of Osteopathic Cranial Manipulative Medicine on Visual Function

March 30, 2016 updated by: Nova Southeastern University
The purpose of this study is to determine if there is a measurable change in visual function as a direct result of the application of osteopathic cranial manipulative medicine. The study will also attempt to determine whether any changes noted remain after withdrawal of the treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

113

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

No

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 osteopathic cranial manipulative medicine

Exclusion Criteria:

  • pregnancy
  • history of previous closed head trauma or brain injury
  • prior cranial manipulative treatment/craniosacral therapy
  • students from the Nova Southeastern University Colleges of Osteopathic Medicine and Optometry

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cranial manipulation

Assessment for cranial strain patterns, followed by indirect cranial manipulation to treat dysfunctions found on assessment, followed by reassessment.

Repeated for a total of eight visits no less than one week apart.
Procedure: Cranial Manipulation
Performed by exaggerating the motion asymmetry with a minimum of pressure (a few ounces) and holding the position until the motion becomes symmetrical.
Other Names:
  • Osteopathy in the Cranial Field
  • Osteopathic Cranial Manipulative Medicine
Sham Comparator: Sham/placebo
Assessment for cranial strain patterns, followed a laying on of hands, followed by reassessment. Repeated for a total of eight visits no less than one week apart.
Procedure: Sham/Placebo
A laying on of hands with no actual treatment being performed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Distance Visual Acuity
Time Frame: Weekly for 16 weeks
Measurement of visual acuity in each eye by number of letters read correctly on ETDRS chart.
Weekly for 16 weeks
Accommodative System Testing
Time Frame: Weekly for 16 weeks
Accommodative amplitude testing using a Donder push-up card.
Weekly for 16 weeks
Local Stereoacuity Testing
Time Frame: Weekly for 16 weeks
Measured by Random Dot E test.
Weekly for 16 weeks
Pupillary Size Testing
Time Frame: Weekly for 16 weeks
Measurement of pupil size (each eye) in bright and dim light.
Weekly for 16 weeks
Vergence System Testing
Time Frame: Weekly for 16 weeks
Assessed by Cover Test with Prism Neutralization and Near Point of Convergence
Weekly for 16 weeks

Collaborators and Investigators

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

Sponsor

Nova Southeastern University

Collaborators

Osteopathic Heritage Foundations

Investigators

  • Principal Investigator: Mark Sandhouse, D.O., M.S., 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

August 1, 2003

Primary Completion (Actual)

November 1, 2005

Study Completion (Actual)

November 1, 2005

Study Registration Dates

First Submitted

April 3, 2014

First Submitted That Met QC Criteria

March 30, 2016

First Posted (Estimate)

April 5, 2016

Study Record Updates

Last Update Posted (Estimate)

April 5, 2016

Last Update Submitted That Met QC Criteria

March 30, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HPD-OST07220201

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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