Study of Osteopathic Manipulative Medicine on the Autonomic Nervous System

July 1, 2019 updated by: New York Institute of Technology

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
126

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Old Westbury, New York, United States, 11568
        • New York Institute of Technology College of Osteopathic Medicine Academic Health Care Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Sub-Occipital Release
Osteopathic Manual Medicine
Other: Osteopathic Manual Medicine
Osteopathic Manual Medicine
Other Names:
  • Sub-Occipital Release
  • Rib-Raising
  • Stellate Ganglion Release
Active Comparator: Rib-Raising
Osteopathic Manual Medicine
Other: Osteopathic Manual Medicine
Osteopathic Manual Medicine
Other Names:
  • Sub-Occipital Release
  • Rib-Raising
  • Stellate Ganglion Release
Active Comparator: Stellate Ganglion Release
Osteopathic Manual Medicine
Other: Osteopathic Manual Medicine
Osteopathic Manual Medicine
Other Names:
  • Sub-Occipital Release
  • Rib-Raising
  • Stellate Ganglion Release
Active Comparator: All techniques
Osteopathic Manual Medicine
Other: Osteopathic Manual Medicine
Osteopathic Manual Medicine
Other Names:
  • Sub-Occipital Release
  • Rib-Raising
  • Stellate Ganglion Release
Sham Comparator: All Techniques-S
Sham Osteopathic Manual Medicine
Other: Sham
Osteopathic Manual Medicine
Other Names:
  • Sham sub-occipital release
  • Sham stellate ganglion release
  • Sham rib raising
Sham Comparator: Sub-Occipital Release-S
Sham Osteopathic Manual Medicine
Other: Sham
Osteopathic Manual Medicine
Other Names:
  • Sham sub-occipital release
  • Sham stellate ganglion release
  • Sham rib raising
Sham Comparator: Rib-Raising-S
Sham Osteopathic Manual Medicine
Other: Sham
Osteopathic Manual Medicine
Other Names:
  • Sham sub-occipital release
  • Sham stellate ganglion release
  • Sham rib raising
Sham Comparator: Stellate Ganglion Release -S
Sham Osteopathic Manual Medicine
Other: Sham
Osteopathic Manual Medicine
Other Names:
  • Sham sub-occipital release
  • Sham stellate ganglion release
  • Sham rib raising

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
one hour

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Effect of Diet and sleep on Heart Rate Variability
Time Frame: Three days
heart rate
Three days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
New York Institute of Technology

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jayme D Mancini, PhD, DO, New York Institute of Technology, College of Osteopathic Medicine
  • Principal Investigator: Theodore Flaum, DO, New York Institute of Technology, College of Osteopathic Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 15, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 15, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 17, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 5, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 1, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BHS-1044

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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