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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
History of Changes
  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
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 May 22, 2013