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Effect of Osteopathic Cranial Manipulative Medicine 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: NCT02728713
Recruitment Status : Completed
First Posted : April 5, 2016
Last Update Posted : April 5, 2016
Sponsor:
Collaborator:
Osteopathic Heritage Foundations
Information provided by (Responsible Party):
Nova Southeastern University

Study Description
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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 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
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 : August 2003
Actual Primary Completion Date : November 2005
Actual Study Completion Date : November 2005
Arms and Interventions
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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
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Primary Outcome Measures :
  1. Distance Visual Acuity [ Time Frame: Weekly for 16 weeks ]
    Measurement of visual acuity in each eye by number of letters read correctly on ETDRS chart.

  2. Accommodative System Testing [ Time Frame: Weekly for 16 weeks ]
    Accommodative amplitude testing using a Donder push-up card.

  3. Local Stereoacuity Testing [ Time Frame: Weekly for 16 weeks ]
    Measured by Random Dot E test.

  4. Pupillary Size Testing [ Time Frame: Weekly for 16 weeks ]
    Measurement of pupil size (each eye) in bright and dim light.

  5. Vergence System Testing [ Time Frame: Weekly for 16 weeks ]
    Assessed by Cover Test with Prism Neutralization and Near Point of Convergence


Eligibility Criteria
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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 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
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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): NCT02728713


Locations
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United States, Florida
Nova Southeastern University Davie Health Center
Ft. Lauderdale, Florida, United States, 33328
Sponsors and Collaborators
Nova Southeastern University
Osteopathic Heritage Foundations
Investigators
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Principal Investigator: Mark Sandhouse, D.O., M.S. Nova Southeastern University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Nova Southeastern University
ClinicalTrials.gov Identifier: NCT02728713    
Other Study ID Numbers: HPD-OST07220201
First Posted: April 5, 2016    Key Record Dates
Last Update Posted: April 5, 2016
Last Verified: March 2016
Keywords provided by Nova Southeastern University:
Cranial manipulation
Visual function