Visual FunctionNCT00510562
Effect of Cranial Osteopathy on Visual Function
A study testing Cranial osteopathic manipulation in people with Visual Function, run by Nova Southeastern University at 1 site in United States.
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. 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 osteopathic manipulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2001to Feb 2002
- 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 cranial osteopathic manipulation
Who cannot join
- 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
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
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.
- Conditions
- Visual Function
- Being tested
- Cranial osteopathic 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 osteopathic manipulationProcedure or surgery
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/PlaceboProcedure or surgery
A laying on of hands with no treatment being performed.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Assessment for cranial strain patterns, followed by indirect osteopathic treatment of dysfunctions found on assessment, followed by reassessment. Receives: Procedure: Cranial osteopathic manipulation |
| 2 | Sham comparator | Assessment for cranial strain patterns, followed by laying on of hands, followed by reassessment. Receives: Procedure: Sham/Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accommodative system testing Visual acuity testing Stereoacuity testing Vergence system testing Pupillary testing
Measured: Immediately after intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2007 (estimated)
- Study startOct 2001
- Study completionFeb 2002
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
- Single blind
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Southeastern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark Sandhouse, Nova Southeastern University
- Investigators
- Mark Sandhouse, D.O., Principal investigator, Nova Southeastern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00510562
- Sponsor's protocol ID
- HPD-COM 06200101
- Status last verified
- Apr 2013
- First submitted
- 1 Aug 2007
- Last updated
- 4 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 20430912
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cranial Osteopathy on Visual Function
- ClinicalTrials.gov ID
- NCT00510562
- Acronym / sponsor ID
- HPD-COM 06200101
- Conditions
- Visual Function
- Keywords
- Cranial manipulation, Visual function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Nova Southeastern UniversityUniversity, hospital or other
- Study start
- Oct 2001
- Study completion
- Feb 2002 (actual)
- First posted
- 2 Aug 2007 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Cranial osteopathic manipulationAssessment for cranial strain patterns, followed by indirect osteopathic treatment of dysfunctions found on assessment, followed by reassessment. |
| 2 | Sham comparator | Procedure: Sham/PlaceboAssessment for cranial strain patterns, followed by laying on of hands, followed by reassessment. |
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 cranial osteopathic manipulation
Key exclusion criteria (4 listed)
- 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
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 osteopathic manipulationThis 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. | Procedure or surgery | 1 |
| Sham/PlaceboA laying on of hands with no treatment being performed. | Procedure or surgery | 2 |
Primary outcome
Accommodative system testing Visual acuity testing Stereoacuity testing Vergence system testing Pupillary testing
Time frame: Immediately after intervention.
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 4 Apr 2013.
- Derived from this study: PubMed 20430912Sandhouse 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.
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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. 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 osteopathic 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 4 Apr 2013. 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?
Accommodative system testing Visual acuity testing Stereoacuity testing Vergence system testing Pupillary testing (time frame: Immediately after intervention.). 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 NCT00510562, 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 4 Apr 2013.