We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of Cranial Osteopathy on Visual Function

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00510562
Recruitment Status : Completed
First Posted : August 2, 2007
Last Update Posted : April 4, 2013
Sponsor:
Information provided by (Responsible Party):

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
Visual Function Procedure: Cranial osteopathic manipulation Procedure: Sham/Placebo

Study Design

Study Type : Interventional  (Clinical Trial)
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 : October 2001
Study Completion Date : February 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.


Outcome Measures

Primary Outcome Measures :
  1. Accommodative system testing Visual acuity testing Stereoacuity testing Vergence system testing Pupillary testing [ Time Frame: Immediately after intervention. ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00510562


Locations
United States, Florida
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
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mark Sandhouse, Associate Professor & Chair, Department of OPP, Nova Southeastern University
ClinicalTrials.gov Identifier: NCT00510562     History of Changes
Other Study ID Numbers: HPD-COM 06200101
First Posted: August 2, 2007    Key Record Dates
Last Update Posted: April 4, 2013
Last Verified: April 2013

Keywords provided by Mark Sandhouse, Nova Southeastern University:
Cranial manipulation
Visual function