Osteopathic Manual Manipulation of Neurovascular RegulationNCT02193373
Study of Osteopathic Manipulative Medicine on the Autonomic Nervous System
A study testing Osteopathic Manual Medicine in people with Osteopathic Manual Manipulation of Neurovascular Regulation, run by New York Institute of Technology at 1 site in United States.
Trial summary
The purpose this study is to determine which manual medicine technique or combination of techniques has the greatest effect on the natural changes in heart rate. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteopathic Manual Manipulation of Neurovascular Regulation
- What is being tested?
- Osteopathic Manual Medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 126 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to May 2018
- 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Individual capable of giving consent between the ages of 20-50
- Normal blood pressure as defined by the Seventh Report of US National Committee on Prevention, Detection, Education and Treatment of High Blood Pressure
- Normal EKG
- Normal Heart Rate
Who cannot join
- Chronic Cardiovascular Disease (including but not limited to: congestive heart failure, previous myocardial infarction, any cardiomyopathy, any arrhythmia, or previous cardiac surgery)
- Hypertension as defined by the Seventh Report of US National Committee on Prevention, Detection, Education and Treatment of High Blood Pressure or hypertensive medications
- Smoking
- Asthma
- Pregnancy
- Diabetes
Show all 10Show fewer
- Current or recent illness (within the past 7 days)
- Any manipulative therapies within the previous 7 days (including but not limited to: osteopathic manipulative treatment, massage or acupuncture)
- Well conditioned athletes (such as long distance runners)
- Anyone who fails to have an increased heart rate with the passive tilt test (50 degrees head-up)
Trial locations and contacts
1 site in 1 country.
United States1 site
New York Institute of Technology College of Osteopathic Medicine Academic Health Care Center
Old Westbury, New York, 11568
About this study
Official title: What is the Best Osteopathic Manipulative Medicine (OMM) Approach to Affect Autonomic Nervous System (ANS) Control of Heart Rate Variability (HRV)?
The purpose this study is to determine which manual medicine technique or combination of techniques has the greatest effect on the natural changes in heart rate.
Read the detailed description
This study intends to examine how three different OMM techniques, sub-occipital release, rib-raising, and stellate ganglion release, impact autonomic nervous system tone. Subjects will be randomly assigned to one of four cohort groups, receiving either sub-occipital release, rib-raising, stellate ganglion release or all three treatment techniques. A shift towards sympathetic tone will be induced in all subjects using a tilted-to-seated-position test (Tilt-Seated Position test) and cognitive challenge test, consisting of computerized questions that become progressively more difficult, and which subjects are asked to answer as quickly and accurately as possible. These stress tests will be induced twice, once without any OMM treatment and a second time with the designated OMM treatment(s). The sympathetic-dependent response to orthostatic change and cognitive challenges will be determined by Fourier analysis of heart rate variability, recorded using an EKG attached to each subject.
- Being tested
- Osteopathic Manual Medicine, Sham
- Keywords
- Osteopathic Manipulative Medicine, Autonomic Nervous System, Heart Rate Variability, Sub-Occipital Release, Rib-Raising, Stellate Ganglion Release
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteopathic Manual MedicineOther
Also called Sub-Occipital Release, Rib-Raising, Stellate Ganglion Release
Osteopathic Manual Medicine
ShamOther
Also called Sham sub-occipital release, Sham stellate ganglion release, Sham rib raising
Osteopathic Manual Medicine
| Study group | Role | What they receive |
|---|---|---|
| Sub-Occipital Release | Active comparator | Osteopathic Manual Medicine Receives: Other: Osteopathic Manual Medicine |
| Rib-Raising | Active comparator | Osteopathic Manual Medicine Receives: Other: Osteopathic Manual Medicine |
| Stellate Ganglion Release | Active comparator | Osteopathic Manual Medicine Receives: Other: Osteopathic Manual Medicine |
| All techniques | Active comparator | Osteopathic Manual Medicine Receives: Other: Osteopathic Manual Medicine |
| All Techniques-S | Sham comparator | Sham Osteopathic Manual Medicine Receives: Other: Sham |
| Sub-Occipital Release-S | Sham comparator | Sham Osteopathic Manual Medicine Receives: Other: Sham |
| Rib-Raising-S | Sham comparator | Sham Osteopathic Manual Medicine Receives: Other: Sham |
| Stellate Ganglion Release -S | Sham comparator | Sham Osteopathic Manual Medicine Receives: Other: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Heart Rate Variability
The participant will lay on a table with electrocardiogram leads recording heart rate while an investigator manually engages the soft tissue on different areas of the participant's head, neck, or back.
Measured: one hour
Secondary outcomes (1)
Effect of Diet and sleep on Heart Rate Variability
heart rate
Measured: Three days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2014 (estimated)
- Study startJun 2014
- Primary completionMay 2018
- Study completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Osteopathic Manual Manipulation of Neurovascular RegulationStudies 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
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York Institute of Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jayme D Mancini, PhD, DO, Principal investigator, New York Institute of Technology, College of Osteopathic MedicineTheodore Flaum, DO, Principal investigator, New York Institute of Technology, College of Osteopathic Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02193373
- Sponsor's protocol ID
- BHS-1044
- Status last verified
- Jul 2019
- First submitted
- 15 Jul 2014
- Last updated
- 5 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Henderson AT, Fisher JF, Blair J, Shea C, Li TS, Bridges KG. Effects of rib raising on the autonomic nervous system: a pilot study using noninvasive biomarkers. J Am Osteopath Assoc. 2010 Jun;110(6):324-30.
PubMed 20606239Shi X, Rehrer S, Prajapati P, Stoll ST, Gamber RG, Downey HF. Effect of cranial osteopathic manipulative medicine on cerebral tissue oxygenation. J Am Osteopath Assoc. 2011 Dec;111(12):660-6.
PubMed 22182951
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What is the Best Osteopathic Manipulative Medicine (OMM) Approach to Affect Autonomic Nervous System (ANS) Control of Heart Rate Variability (HRV)?
- ClinicalTrials.gov ID
- NCT02193373
- Acronym / sponsor ID
- BHS-1044
- Keywords
- Osteopathic Manipulative Medicine, Autonomic Nervous System, Heart Rate Variability, Sub-Occipital Release, Rib-Raising, Stellate Ganglion Release
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- New York Institute of TechnologyUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- May 2018 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 17 Jul 2014 (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 this study is to determine which manual medicine technique or combination of techniques has the greatest effect on the natural changes in heart rate.
Detailed description
This study intends to examine how three different OMM techniques, sub-occipital release, rib-raising, and stellate ganglion release, impact autonomic nervous system tone. Subjects will be randomly assigned to one of four cohort groups, receiving either sub-occipital release, rib-raising, stellate ganglion release or all three treatment techniques. A shift towards sympathetic tone will be induced in all subjects using a tilted-to-seated-position test (Tilt-Seated Position test) and cognitive challenge test, consisting of computerized questions that become progressively more difficult, and which subjects are asked to answer as quickly and accurately as possible. These stress tests will be induced twice, once without any OMM treatment and a second time with the designated OMM treatment(s). The sympathetic-dependent response to orthostatic change and cognitive challenges will be determined by Fourier analysis of heart rate variability, recorded using an EKG attached to each subject.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Sub-Occipital Release | Active comparator | Other: Osteopathic Manual MedicineOsteopathic Manual Medicine |
| Rib-Raising | Active comparator | Other: Osteopathic Manual MedicineOsteopathic Manual Medicine |
| Stellate Ganglion Release | Active comparator | Other: Osteopathic Manual MedicineOsteopathic Manual Medicine |
| All techniques | Active comparator | Other: Osteopathic Manual MedicineOsteopathic Manual Medicine |
| All Techniques-S | Sham comparator | Other: ShamSham Osteopathic Manual Medicine |
| Sub-Occipital Release-S | Sham comparator | Other: ShamSham Osteopathic Manual Medicine |
| Rib-Raising-S | Sham comparator | Other: ShamSham Osteopathic Manual Medicine |
| Stellate Ganglion Release -S | Sham comparator | Other: ShamSham Osteopathic Manual Medicine |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy Individual capable of giving consent between the ages of 20-50
- Normal blood pressure as defined by the Seventh Report of US National Committee on Prevention, Detection, Education and Treatment of High Blood Pressure
- Normal EKG
- Normal Heart Rate
Key exclusion criteria (10 listed)
- Chronic Cardiovascular Disease (including but not limited to: congestive heart failure, previous myocardial infarction, any cardiomyopathy, any arrhythmia, or previous cardiac surgery)
- Hypertension as defined by the Seventh Report of US National Committee on Prevention, Detection, Education and Treatment of High Blood Pressure or hypertensive medications
- Smoking
- Asthma
- Pregnancy
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 |
|---|---|---|
| Osteopathic Manual MedicineAlso: Sub-Occipital Release, Rib-Raising, Stellate Ganglion ReleaseOsteopathic Manual Medicine | Other | All techniques, Rib-Raising, Stellate Ganglion Release, Sub-Occipital Release |
| ShamAlso: Sham sub-occipital release, Sham stellate ganglion release, Sham rib raisingOsteopathic Manual Medicine | Other | All Techniques-S, Rib-Raising-S, Stellate Ganglion Release -S, Sub-Occipital Release-S |
Primary outcome
Change in Heart Rate Variability
Time frame: one hour
The participant will lay on a table with electrocardiogram leads recording heart rate while an investigator manually engages the soft tissue on different areas of the participant's head, neck, or back.
1 secondary outcome
Effect of Diet and sleep on Heart Rate Variability
Time frame: Three days
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 Jul 2019.
- Background: PubMed 20606239Henderson AT, Fisher JF, Blair J, Shea C, Li TS, Bridges KG. Effects of rib raising on the autonomic nervous system: a pilot study using noninvasive biomarkers. J Am Osteopath Assoc. 2010 Jun;110(6):324-30.
- Background: PubMed 22182951Shi X, Rehrer S, Prajapati P, Stoll ST, Gamber RG, Downey HF. Effect of cranial osteopathic manipulative medicine on cerebral tissue oxygenation. J Am Osteopath Assoc. 2011 Dec;111(12):660-6.
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.
Jayme D Mancini, PhD, DO principal investigator
New York Institute of Technology, College of Osteopathic Medicine
Theodore Flaum, DO principal investigator
New York Institute of Technology, College of Osteopathic Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Osteopathic Manual Medicine in people with Osteopathic Manual Manipulation of Neurovascular Regulation, run by New York Institute of Technology 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 4 inclusion and 10 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 Jul 2019. 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?
Change in Heart Rate Variability (time frame: one hour). 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 NCT02193373, which also lists 2 linked publications.
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 Jul 2019.