Effect of Osteopathic Cranial Manipulative Medicine on Visual Function

NCT ID: NCT02728713

Last Updated: 2016-04-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

113 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-08-31

Study Completion Date

2005-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Visual Function

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Cranial Manipulation

Intervention Type PROCEDURE

Performed by exaggerating the motion asymmetry with a minimum of pressure (a few ounces) and holding the position until the motion becomes symmetrical.

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.

Group Type SHAM_COMPARATOR

Sham/Placebo

Intervention Type PROCEDURE

A laying on of hands with no actual treatment being performed.

Interventions

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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.

Intervention Type PROCEDURE

Sham/Placebo

A laying on of hands with no actual treatment being performed.

Intervention Type PROCEDURE

Other Intervention Names

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Osteopathy in the Cranial Field Osteopathic Cranial Manipulative Medicine

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Osteopathic Heritage Foundations

OTHER

Sponsor Role collaborator

Nova Southeastern University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mark Sandhouse, D.O., M.S.

Role: PRINCIPAL_INVESTIGATOR

Nova Southeastern University

Locations

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Nova Southeastern University Davie Health Center

Fort Lauderdale, Florida, United States

Site Status

Countries

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United States

References

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Sandhouse ME, Shechtman D, Fecho G, Timoshkin EM. Effect of Osteopathic Cranial Manipulative Medicine on Visual Function. J Am Osteopath Assoc. 2016 Nov 1;116(11):706-714. doi: 10.7556/jaoa.2016.141.

Reference Type DERIVED
PMID: 27802556 (View on PubMed)

Other Identifiers

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HPD-OST07220201

Identifier Type: -

Identifier Source: org_study_id

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