Study of Osteopathic Manipulative Medicine on the Autonomic Nervous System

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Osteopathic Manual Manipulation of Neurovascular Regulation

Intervention / Treatment
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* Other: Osteopathic Manual Medicine
* Other: Sham


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sub-Occipital Release<br>Osteopathic Manual Medicine | Other: Osteopathic Manual Medicine<br>* Osteopathic Manual Medicine<br>* Other names: Stellate Ganglion Release;|
| Active Comparator: Rib-Raising<br>Osteopathic Manual Medicine | Other: Osteopathic Manual Medicine<br>* Osteopathic Manual Medicine<br>* Other names: Stellate Ganglion Release;|
| Active Comparator: Stellate Ganglion Release<br>Osteopathic Manual Medicine | Other: Osteopathic Manual Medicine<br>* Osteopathic Manual Medicine<br>* Other names: Stellate Ganglion Release;|
| Active Comparator: All techniques<br>Osteopathic Manual Medicine | Other: Osteopathic Manual Medicine<br>* Osteopathic Manual Medicine<br>* Other names: Stellate Ganglion Release;|
| Sham Comparator: All Techniques-S<br>Sham Osteopathic Manual Medicine | Other: Sham<br>* Osteopathic Manual Medicine<br>* Other names: Sham rib raising;|
| Sham Comparator: Sub-Occipital Release-S<br>Sham Osteopathic Manual Medicine | Other: Sham<br>* Osteopathic Manual Medicine<br>* Other names: Sham rib raising;|
| Sham Comparator: Rib-Raising-S<br>Sham Osteopathic Manual Medicine | Other: Sham<br>* Osteopathic Manual Medicine<br>* Other names: Sham rib raising;|
| Sham Comparator: Stellate Ganglion Release -S<br>Sham Osteopathic Manual Medicine | Other: Sham<br>* Osteopathic Manual Medicine<br>* Other names: Sham rib raising;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | one hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of Diet and sleep on Heart Rate Variability | heart rate | Three days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteopathic Manipulative Medicine, Autonomic Nervous System, Heart Rate Variability, Sub-Occipital Release, Rib-Raising, Stellate Ganglion Release