Muscle TensionNCT00403936
Effects of OA Decompression on the Autonomic Nervous System
A study testing OA decompression manipulation in people with Muscle Tension, run by Nova Southeastern University at 1 site in United States.
Trial summary
This study was designed to determine whether a simple manipulative technique of relaxing the tissues of the occipito-atlantal junction in the neck had any effect on the activity of the sympathetic or parasympathetic nervous system. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Muscle Tension
- What is being tested?
- OA decompression manipulation
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2005to May 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 y/o
- Normal accommodation and pupillary response
- Willing to undergo osteopathic manipulation
Who cannot join
- Active ocular or systemic disease
- Neurologic disease that would alter pupillary response
- Chronic pain syndromes of head or neck
- Pregnant
- Brain injury
- Taking medications that would alter autonomic tone
Trial locations and contacts
1 site in 1 country.
United States1 site
College of Osteopathic Med, Nova Southeastern Univ
Fort Lauderdale, Florida, 33328
About this study
Official title: Effects of OA Decompression on Activity of the Autonomic Nervous System
This study was designed to determine whether a simple manipulative technique of relaxing the tissues of the occipito-atlantal junction in the neck had any effect on the activity of the sympathetic or parasympathetic nervous system. Subjects were dark adapted then measures of pupillary activity, reflecting autonomic nervous system activity were taken before and after treatment. The study hypothesis was that thet treatment technique would have no effect on the pupillary measures, hence indicating no effect on autonomic system activity.
Read the detailed description
This study was a within subjects/crossover design in which each subject received the treatment and served as his/her own control. 100 subjects were recruited from the student/staff population of the university, were 18 y/o or older with no condition affecting pupillary activity. Pupillary activity was measured with a PLR100 pupillometer and included pupillary diameter, pupillary response latency, maximum constriction velocity and maximum redilation velocity. Subjects were adapted to a dim light environment, measures taken, treatment given at either third or fourth time period and measures retaken. The study was approved by the NSU IRB. Subject numbers were sufficient to have statistical power to find an effect. The study found an effect of treatment on maximum size, showing a decrease with treatment.
- Conditions
- Muscle Tension
- Being tested
- OA decompression manipulation
- Keywords
- osteopathic manipulation, autonomic nervous system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OA decompression manipulationProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
pupillary diameter
pupillary latency
pupillary constriction velocity
pupillary redilation velocity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2006 (estimated)
- Study startApr 2005
- Study completionMay 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle TensionStudies 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
- Crossover
- Masking
- Single blind
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- Nova Southeastern University
- Sponsor type
- University, hospital or other
- Investigators
- Chris Piromalli, MSIII, Principal investigator, College of Osteo Med, Nova Southeastern Univ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00403936
- Sponsor's protocol ID
- OAdecompress1
- Status last verified
- Feb 2010
- First submitted
- 22 Nov 2006
- Last updated
- 25 Feb 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of OA Decompression on Activity of the Autonomic Nervous System
- ClinicalTrials.gov ID
- NCT00403936
- Acronym / sponsor ID
- OAdecompress1
- Conditions
- Muscle Tension
- Keywords
- osteopathic manipulation, autonomic nervous system
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants
- Lead sponsor
- Nova Southeastern UniversityUniversity, hospital or other
- Study start
- Apr 2005
- Study completion
- May 2005
- First posted
- 27 Nov 2006 (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.
This study was designed to determine whether a simple manipulative technique of relaxing the tissues of the occipito-atlantal junction in the neck had any effect on the activity of the sympathetic or parasympathetic nervous system. Subjects were dark adapted then measures of pupillary activity, reflecting autonomic nervous system activity were taken before and after treatment. The study hypothesis was that thet treatment technique would have no effect on the pupillary measures, hence indicating no effect on autonomic system activity.
Detailed description
This study was a within subjects/crossover design in which each subject received the treatment and served as his/her own control. 100 subjects were recruited from the student/staff population of the university, were 18 y/o or older with no condition affecting pupillary activity. Pupillary activity was measured with a PLR100 pupillometer and included pupillary diameter, pupillary response latency, maximum constriction velocity and maximum redilation velocity. Subjects were adapted to a dim light environment, measures taken, treatment given at either third or fourth time period and measures retaken. The study was approved by the NSU IRB. Subject numbers were sufficient to have statistical power to find an effect. The study found an effect of treatment on maximum size, showing a decrease with treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 y/o
- Normal accommodation and pupillary response
- Willing to undergo osteopathic manipulation
Key exclusion criteria (6 listed)
- Active ocular or systemic disease
- Neurologic disease that would alter pupillary response
- Chronic pain syndromes of head or neck
- Pregnant
- Brain injury
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 |
|---|---|---|
| OA decompression manipulation | Procedure or surgery | – |
Primary outcome
pupillary diameter
pupillary latency
pupillary constriction velocity
pupillary redilation velocity
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 25 Feb 2010.
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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.
Chris Piromalli, MSIII principal investigator
College of Osteo Med, Nova Southeastern Univ
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OA decompression manipulation in people with Muscle Tension, 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 3 inclusion and 6 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 25 Feb 2010. 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. 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?
pupillary diameter. The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Feb 2010.