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Study of Osteopathic Manipulative Medicine on the Autonomic Nervous System

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02193373
Enrollment
126
Registered
2014-07-17
Start date
2014-06-30
Completion date
2018-05-31
Last updated
2019-07-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteopathic Manual Manipulation of Neurovascular Regulation

Keywords

Osteopathic Manipulative Medicine, Autonomic Nervous System, Heart Rate Variability, Sub-Occipital Release, Rib-Raising, Stellate Ganglion Release

Brief summary

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

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.

Interventions

OTHEROsteopathic Manual Medicine

Osteopathic Manual Medicine

OTHERSham

Osteopathic Manual Medicine

Sponsors

New York Institute of Technology
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Change in Heart Rate Variabilityone hourThe 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

MeasureTime frameDescription
Effect of Diet and sleep on Heart Rate VariabilityThree daysheart rate

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026