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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00510562
Other study ID # HPD-COM 06200101
Secondary ID
Status Completed
Phase N/A
First received August 1, 2007
Last updated April 2, 2013
Start date October 2001
Est. completion date February 2002

Study information

Verified date April 2013
Source Nova Southeastern University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 29
Est. completion date February 2002
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 35 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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/Placebo
A laying on of hands with no treatment being performed.

Locations

Country Name City State
United States Nova Southeastern University Davie Health Center Ft. Lauderdale Florida

Sponsors (1)

Lead Sponsor Collaborator
Nova Southeastern University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Accommodative system testing Visual acuity testing Stereoacuity testing Vergence system testing Pupillary testing Immediately after intervention. No
See also
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