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Completed

NCT Number: NCT02193373

Study of Osteopathic Manipulative Medicine on the Autonomic Nervous System

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.

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Key information

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New York Institute of Technology College of Osteopathic Medicine Academic Health Care Center

Old Westbury, New York, 11568, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Osteopathic Manual Medicine

Other

Osteopathic Manual Medicine

Other names: Sub-Occipital Release, Rib-Raising, Stellate Ganglion Release

SHAM

Other

Osteopathic Manual Medicine

Other names: Sham sub-occipital release, Sham stellate ganglion release, Sham rib raising

Primary outcomes

  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 outcomes

  1. Effect of Diet and sleep on Heart Rate Variability

    Time frame: Three days

    heart rate

Sponsors and collaborators

Lead sponsor

New York Institute of Technology

Other

Registry information

Official study title

What is the Best Osteopathic Manipulative Medicine (OMM) Approach to Affect Autonomic Nervous System (ANS) Control of Heart Rate Variability (HRV)?

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Jul 17, 2014
Registry last updated
Jul 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.