Effect of Cranial Osteopathy on Visual Function

Sponsor

Nova Southeastern University (Other)

Overall Status

Completed

CT.gov ID

NCT00510562

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

7.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

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

Study Design

Study Type:

Interventional

Actual Enrollment :

29 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single

Primary Purpose:

Treatment

Official Title:

Effect of Cranial Osteopathy on Visual Function

Study Start Date :

Oct 1, 2001

Actual Study Completion Date :

Feb 1, 2002

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Accommodative system testing Visual acuity testing Stereoacuity testing Vergence system testing Pupillary testing [Immediately after intervention.]

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 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

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

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mark Sandhouse, Associate Professor & Chair, Department of OPP, Nova Southeastern University

ClinicalTrials.gov Identifier:

NCT00510562

Other Study ID Numbers:

HPD-COM 06200101

First Posted:

Aug 2, 2007

Last Update Posted:

Apr 4, 2013

Last Verified:

Apr 1, 2013

Keywords provided by Mark Sandhouse, Associate Professor & Chair, Department of OPP, Nova Southeastern University

Cranial manipulation

Visual function

Study Results

No Results Posted as of Apr 4, 2013