NCT00510562

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2001

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2001

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2002

Completed
5.5 years until next milestone

First Submitted

Initial submission to the registry

August 1, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 2, 2007

Completed
Last Updated

April 4, 2013

Status Verified

April 1, 2013

First QC Date

August 1, 2007

Last Update Submit

April 2, 2013

Conditions

Visual Function

Keywords

Cranial manipulationVisual function

Outcome Measures

Primary Outcomes (1)

  • Accommodative system testing Visual acuity testing Stereoacuity testing Vergence system testing Pupillary testing

    Immediately after intervention.

Study Arms (2)

1

EXPERIMENTAL

Assessment for cranial strain patterns, followed by indirect osteopathic treatment of dysfunctions found on assessment, followed by reassessment.

Procedure: Cranial osteopathic manipulation

2

SHAM COMPARATOR

Assessment for cranial strain patterns, followed by laying on of hands, followed by reassessment.

Procedure: Sham/Placebo

Interventions

Cranial osteopathic manipulationPROCEDURE

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.

1
Sham/PlaceboPROCEDURE

A laying on of hands with no treatment being performed.

2

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nova Southeastern University Davie Health Center

Fort Lauderdale, Florida, 33328, United States

Location

Related Publications (1)

  • Sandhouse ME, Shechtman D, Sorkin R, Drowos JL, Caban-Martinez AJ 3rd, Patterson MM, Shallo-Hoffmann J, Hardigan P, Snyder A. Effect of osteopathy in the cranial field on visual function--a pilot study. J Am Osteopath Assoc. 2010 Apr;110(4):239-43.

    PMID: 20430912DERIVED

Study Officials

  • Mark Sandhouse, D.O.

    Nova Southeastern University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor & Chair, Department of OPP

Study Record Dates

First Submitted

August 1, 2007

First Posted

August 2, 2007

Study Start

October 1, 2001

Study Completion

February 1, 2002

Last Updated

April 4, 2013

Record last verified: 2013-04

Locations

US(1)