Effect of Osteopathic Cranial Manipulative Medicine on Visual Function

Sponsor

Nova Southeastern University (Other)

Overall Status

Completed

CT.gov ID

NCT02728713

Collaborator

Osteopathic Heritage Foundations (Other)

113

Enrollment

Location

Arms

Duration (Months)

4.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Visual Function	Procedure: Cranial Manipulation Procedure: Sham/Placebo	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

113 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Effect of Osteopathic Cranial Manipulative Medicine on Visual Function

Study Start Date :

Aug 1, 2003

Actual Primary Completion Date :

Nov 1, 2005

Actual Study Completion Date :

Nov 1, 2005

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 35 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nova Southeastern University Davie Health Center	Ft. Lauderdale	Florida	United States	33328

Sponsors and Collaborators

Nova Southeastern University
Osteopathic Heritage Foundations

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nova Southeastern University

ClinicalTrials.gov Identifier:

NCT02728713

Other Study ID Numbers:

HPD-OST07220201

First Posted:

Apr 5, 2016

Last Update Posted:

Apr 5, 2016

Last Verified:

Mar 1, 2016

Keywords provided by Nova Southeastern University

Cranial manipulation

Visual function

Study Results

No Results Posted as of Apr 5, 2016