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Study of Osteopathic Manipulative Medicine on the Autonomic Nervous System

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ClinicalTrials.gov Identifier: NCT02193373
Recruitment Status : Recruiting
First Posted : July 17, 2014
Last Update Posted : October 12, 2017
Sponsor:
Information provided by (Responsible Party):
New York Institute of Technology

Brief 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.

Condition or disease Intervention/treatment Phase
Osteopathic Manual Manipulation of Neurovascular Regulation Other: Osteopathic Manual Medicine Other: Sham Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: What is the Best Osteopathic Manipulative Medicine (OMM) Approach to Affect Autonomic Nervous System (ANS) Control of Heart Rate Variability (HRV)?
Study Start Date : June 2014
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : September 2018

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Effect of Diet and sleep on Heart Rate Variability [ Time Frame: Three days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02193373


Contacts
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Contact: Jayme C Mancini, PhD, DO 5166861237 jmancini@nyit.edu
Contact: Sim Basta 516-686-1300 sbasta@nyit.edu

Locations
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United States, New York
New York Institute of Technology College of Osteopathic Medicine Academic Health Care Center Recruiting
Old Westbury, New York, United States, 11568
Contact: Jayme D Mancini, DO PhD    516-686-1237    jmancini@nyit.edu   
Sponsors and Collaborators
New York Institute of Technology
Investigators
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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:
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Responsible Party: New York Institute of Technology
ClinicalTrials.gov Identifier: NCT02193373     History of Changes
Other Study ID Numbers: BHS-1044
First Posted: July 17, 2014    Key Record Dates
Last Update Posted: October 12, 2017
Last Verified: October 2017

Keywords provided by New York Institute of Technology:
Osteopathic Manipulative Medicine
Autonomic Nervous System
Heart Rate Variability
Sub-Occipital Release
Rib-Raising
Stellate Ganglion Release