- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00510562
Effect of Cranial Osteopathy on Visual Function
April 2, 2013 updated by: Mark Sandhouse, Nova Southeastern University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
29
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Florida
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Ft. Lauderdale, Florida, United States, 33328
- Nova Southeastern University Davie Health Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 35 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Assessment for cranial strain patterns, followed by indirect osteopathic treatment of dysfunctions found on assessment, followed by reassessment.
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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.
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Sham Comparator: 2
Assessment for cranial strain patterns, followed by laying on of hands, followed by reassessment.
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A laying on of hands with no treatment being performed.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Accommodative system testing Visual acuity testing Stereoacuity testing Vergence system testing Pupillary testing
Time Frame: Immediately after intervention.
|
Immediately after intervention.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Mark Sandhouse, D.O., Nova Southeastern University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2001
Study Completion (Actual)
February 1, 2002
Study Registration Dates
First Submitted
August 1, 2007
First Submitted That Met QC Criteria
August 1, 2007
First Posted (Estimate)
August 2, 2007
Study Record Updates
Last Update Posted (Estimate)
April 4, 2013
Last Update Submitted That Met QC Criteria
April 2, 2013
Last Verified
April 1, 2013
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- HPD-COM 06200101
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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