Study of Osteopathic Manipulative Medicine on the Autonomic Nervous System

N/ACompletedNCT02193373

New York Institute of Technology126 enrolled

Overview

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.

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

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

126

Conditions

Osteopathic Manual Manipulation of Neurovascular Regulation

Interventions

Osteopathic Manual MedicineOTHER

Osteopathic Manual Medicine

ShamOTHER

Osteopathic Manual Medicine

Eligibility

Sex: ALLMin age: 20 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

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

Old Westbury, New York, United States

Outcomes

Primary Outcomes

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.

Time frame: one hour

Secondary Outcomes

Effect of Diet and sleep on Heart Rate Variability

heart rate

Time frame: Three days

Data from ClinicalTrials.gov

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