Study of Osteopathic Manipulative Medicine on the Autonomic Nervous System

NCT ID: NCT02193373

Last Updated: 2019-07-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2018-05-31

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.

Conditions

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Osteopathic Manual Manipulation of Neurovascular Regulation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Sub-Occipital Release

Osteopathic Manual Medicine

Group Type ACTIVE_COMPARATOR

Osteopathic Manual Medicine

Intervention Type OTHER

Osteopathic Manual Medicine

Rib-Raising

Osteopathic Manual Medicine

Group Type ACTIVE_COMPARATOR

Osteopathic Manual Medicine

Intervention Type OTHER

Osteopathic Manual Medicine

Stellate Ganglion Release

Osteopathic Manual Medicine

Group Type ACTIVE_COMPARATOR

Osteopathic Manual Medicine

Intervention Type OTHER

Osteopathic Manual Medicine

All techniques

Osteopathic Manual Medicine

Group Type ACTIVE_COMPARATOR

Osteopathic Manual Medicine

Intervention Type OTHER

Osteopathic Manual Medicine

All Techniques-S

Sham Osteopathic Manual Medicine

Group Type SHAM_COMPARATOR

Sham

Intervention Type OTHER

Osteopathic Manual Medicine

Sub-Occipital Release-S

Sham Osteopathic Manual Medicine

Group Type SHAM_COMPARATOR

Sham

Intervention Type OTHER

Osteopathic Manual Medicine

Rib-Raising-S

Sham Osteopathic Manual Medicine

Group Type SHAM_COMPARATOR

Sham

Intervention Type OTHER

Osteopathic Manual Medicine

Stellate Ganglion Release -S

Sham Osteopathic Manual Medicine

Group Type SHAM_COMPARATOR

Sham

Intervention Type OTHER

Osteopathic Manual Medicine

Interventions

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Osteopathic Manual Medicine

Osteopathic Manual Medicine

Intervention Type OTHER

Sham

Osteopathic Manual Medicine

Intervention Type OTHER

Other Intervention Names

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Sub-Occipital Release Rib-Raising Stellate Ganglion Release Sham sub-occipital release Sham stellate ganglion release Sham rib raising

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)
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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New York Institute of Technology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jayme D Mancini, PhD, DO

Role: PRINCIPAL_INVESTIGATOR

New York Institute of Technology, College of Osteopathic Medicine

Theodore Flaum, DO

Role: PRINCIPAL_INVESTIGATOR

New York Institute of Technology, College of Osteopathic Medicine

Locations

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

Old Westbury, New York, United States

Site Status

Countries

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United States

References

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Henderson AT, Fisher JF, Blair J, Shea C, Li TS, Bridges KG. Effects of rib raising on the autonomic nervous system: a pilot study using noninvasive biomarkers. J Am Osteopath Assoc. 2010 Jun;110(6):324-30.

Reference Type BACKGROUND
PMID: 20606239 (View on PubMed)

Shi X, Rehrer S, Prajapati P, Stoll ST, Gamber RG, Downey HF. Effect of cranial osteopathic manipulative medicine on cerebral tissue oxygenation. J Am Osteopath Assoc. 2011 Dec;111(12):660-6.

Reference Type BACKGROUND
PMID: 22182951 (View on PubMed)

Other Identifiers

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BHS-1044

Identifier Type: -

Identifier Source: org_study_id

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