Study of Osteopathic Manipulative Medicine on the Autonomic Nervous System

New York Institute of Technology

Status: Completed

Conditions: Osteopathic Manual Manipulation of Neurovascular Regulation

Treatments: Other: Sham; Other: Osteopathic Manual Medicine

Study type: Interventional

Funder types: Other

Identifiers

NCT02193373

BHS-1044

Details and patient eligibility

About

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.

Full 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.

Enrollment: 126 patients

Sex: All

Ages: 20 to 50 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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126 participants in 8 patient groups

Sub-Occipital Release

Active Comparator group

Description:

Osteopathic Manual Medicine

Treatment:

Other: Osteopathic Manual Medicine

Rib-Raising

Active Comparator group

Description:

Osteopathic Manual Medicine

Treatment:

Other: Osteopathic Manual Medicine

Stellate Ganglion Release

Active Comparator group

Description:

Osteopathic Manual Medicine

Treatment:

Other: Osteopathic Manual Medicine

All techniques

Active Comparator group

Description:

Osteopathic Manual Medicine

Treatment:

Other: Osteopathic Manual Medicine

All Techniques-S

Sham Comparator group

Description:

Sham Osteopathic Manual Medicine

Treatment:

Other: Sham

Sub-Occipital Release-S

Sham Comparator group

Description:

Sham Osteopathic Manual Medicine

Treatment:

Other: Sham

Rib-Raising-S

Sham Comparator group

Description:

Sham Osteopathic Manual Medicine

Treatment:

Other: Sham

Stellate Ganglion Release -S

Sham Comparator group

Description:

Sham Osteopathic Manual Medicine

Treatment:

Other: Sham