Visual FunctionNCT02728713
Effect of Osteopathic Cranial Manipulative Medicine on Visual Function
A study testing Cranial Manipulation in people with Visual Function, run by Nova Southeastern University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Visual Function
- What is being tested?
- Cranial Manipulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 113 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2003to Nov 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Nova Southeastern University Davie Health Center
Fort Lauderdale, Florida, 33328
About this study
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.
- Conditions
- Visual Function
- Being tested
- Cranial Manipulation, Sham/Placebo
- Keywords
- Cranial manipulation, Visual function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cranial ManipulationProcedure or surgery
Also called Osteopathy in the Cranial Field, Osteopathic Cranial Manipulative Medicine
Performed by exaggerating the motion asymmetry with a minimum of pressure (a few ounces) and holding the position until the motion becomes symmetrical.
Sham/PlaceboProcedure or surgery
A laying on of hands with no actual treatment being performed.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Sham/Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distance Visual Acuity
Measurement of visual acuity in each eye by number of letters read correctly on ETDRS chart.
Measured: Weekly for 16 weeks
Accommodative System Testing
Accommodative amplitude testing using a Donder push-up card.
Measured: Weekly for 16 weeks
Local Stereoacuity Testing
Measured by Random Dot E test.
Measured: Weekly for 16 weeks
Pupillary Size Testing
Measurement of pupil size (each eye) in bright and dim light.
Measured: Weekly for 16 weeks
Vergence System Testing
Assessed by Cover Test with Prism Neutralization and Near Point of Convergence
Measured: Weekly for 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2016 (estimated)
- Study startAug 2003
- Primary completionNov 2005
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Visual FunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Southeastern University
- Sponsor type
- University, hospital or other
- Collaborators
- Osteopathic Heritage Foundations
- Responsible party
- Sponsor
- Investigators
- Mark Sandhouse, D.O., M.S., Principal investigator, Nova Southeastern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02728713
- Sponsor's protocol ID
- HPD-OST07220201
- Status last verified
- Mar 2016
- First submitted
- 3 Apr 2014
- Last updated
- 5 Apr 2016
- Results posted
- No
Publications
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.
PubMed 27802556
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Osteopathic Cranial Manipulative Medicine on Visual Function
- ClinicalTrials.gov ID
- NCT02728713
- Acronym / sponsor ID
- HPD-OST07220201
- Conditions
- Visual Function
- Keywords
- Cranial manipulation, Visual function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Nova Southeastern UniversityUniversity, hospital or other
- Collaborators
- Osteopathic Heritage Foundations
- Study start
- Aug 2003
- Primary completion
- Nov 2005 (actual)
- Study completion
- Nov 2005 (actual)
- First posted
- 5 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cranial manipulation | Experimental | Procedure: Cranial ManipulationAssessment 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. |
| Sham/placebo | Sham comparator | Procedure: Sham/PlaceboAssessment 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cranial ManipulationAlso: Osteopathy in the Cranial Field, Osteopathic Cranial Manipulative MedicinePerformed by exaggerating the motion asymmetry with a minimum of pressure (a few ounces) and holding the position until the motion becomes symmetrical. | Procedure or surgery | Cranial manipulation |
| Sham/PlaceboA laying on of hands with no actual treatment being performed. | Procedure or surgery | Sham/placebo |
Primary outcome
Distance Visual Acuity
Time frame: Weekly for 16 weeks
Measurement of visual acuity in each eye by number of letters read correctly on ETDRS chart.
Accommodative System Testing
Time frame: Weekly for 16 weeks
Accommodative amplitude testing using a Donder push-up card.
Local Stereoacuity Testing
Time frame: Weekly for 16 weeks
Measured by Random Dot E test.
Pupillary Size Testing
Time frame: Weekly for 16 weeks
Measurement of pupil size (each eye) in bright and dim light.
Vergence System Testing
Time frame: Weekly for 16 weeks
Assessed by Cover Test with Prism Neutralization and Near Point of Convergence
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2016.
- Derived from this study: PubMed 27802556Sandhouse 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Sandhouse, D.O., M.S. principal investigator
Nova Southeastern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cranial Manipulation in people with Visual Function, run by Nova Southeastern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distance Visual Acuity (time frame: Weekly for 16 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02728713, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2016.