Effect of Cranial Osteopathy on Visual Function

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mark Sandhouse, Nova Southeastern University
ClinicalTrials.gov Identifier:
NCT00510562
First received: August 1, 2007
Last updated: April 2, 2013
Last verified: April 2013
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Effect of Cranial Osteopathy on Visual Function

Further study details as provided by Nova Southeastern University:

Primary Outcome Measures:
  • Accommodative system testing Visual acuity testing Stereoacuity testing Vergence system testing Pupillary testing [ Time Frame: Immediately after intervention. ] [ Designated as safety issue: No ]

Enrollment: 29
Study Start Date: October 2001
Study Completion Date: February 2002
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Nova Southeastern University

Additional 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
Study First Received: August 1, 2007
Last Updated: April 2, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Nova Southeastern University:
Cranial manipulation
Visual function

ClinicalTrials.gov processed this record on October 01, 2014