NCT02728713

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
113

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2003

Typical duration 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

August 1, 2003

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2005

Completed
8.4 years until next milestone

First Submitted

Initial submission to the registry

April 3, 2014

Completed
2 years until next milestone

First Posted

Study publicly available on registry

April 5, 2016

Completed
Last Updated

April 5, 2016

Status Verified

March 1, 2016

Enrollment Period

2.3 years

First QC Date

April 3, 2014

Last Update Submit

March 30, 2016

Conditions

Visual Function

Keywords

Cranial manipulationVisual function

Outcome Measures

Primary Outcomes (5)

  • Distance Visual Acuity

    Measurement of visual acuity in each eye by number of letters read correctly on ETDRS chart.

    Weekly for 16 weeks

  • Accommodative System Testing

    Accommodative amplitude testing using a Donder push-up card.

    Weekly for 16 weeks

  • Local Stereoacuity Testing

    Measured by Random Dot E test.

    Weekly for 16 weeks

  • Pupillary Size Testing

    Measurement of pupil size (each eye) in bright and dim light.

    Weekly for 16 weeks

  • Vergence System Testing

    Assessed by Cover Test with Prism Neutralization and Near Point of Convergence

    Weekly for 16 weeks

Study Arms (2)

Cranial manipulation

EXPERIMENTAL

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

Sham/placebo

SHAM COMPARATOR

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

Interventions

Cranial ManipulationPROCEDURE

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

Also known as: Osteopathy in the Cranial Field, Osteopathic Cranial Manipulative Medicine
Cranial manipulation
Sham/PlaceboPROCEDURE

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

Sham/placebo

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 osteopathic cranial manipulative medicine

You may not qualify if:

  • 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

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, 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.

    PMID: 27802556DERIVED

Study Officials

  • Mark Sandhouse, D.O., M.S.

    Nova Southeastern University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 3, 2014

First Posted

April 5, 2016

Study Start

August 1, 2003

Primary Completion

November 1, 2005

Study Completion

November 1, 2005

Last Updated

April 5, 2016

Record last verified: 2016-03

Locations

US(1)