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)?

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.

Study Overview

• Status: Completed
• Conditions: Osteopathic Manual Manipulation of Neurovascular Regulation
• Intervention / Treatment: Other: Osteopathic Manual Medicine; Other: Sham

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.

• Study Type: Interventional
• Enrollment (Actual): 126
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Old Westbury, New York, United States, 11568
      • New York Institute of Technology College of Osteopathic Medicine Academic Health Care Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Sub-Occipital Release; Osteopathic Manual Medicine	Other: Osteopathic Manual Medicine; Osteopathic Manual Medicine; Other Names: Sub-Occipital Release; Rib-Raising; Stellate Ganglion Release
Active Comparator: Rib-Raising; Osteopathic Manual Medicine	Other: Osteopathic Manual Medicine; Osteopathic Manual Medicine; Other Names: Sub-Occipital Release; Rib-Raising; Stellate Ganglion Release
Active Comparator: Stellate Ganglion Release; Osteopathic Manual Medicine	Other: Osteopathic Manual Medicine; Osteopathic Manual Medicine; Other Names: Sub-Occipital Release; Rib-Raising; Stellate Ganglion Release
Active Comparator: All techniques; Osteopathic Manual Medicine	Other: Osteopathic Manual Medicine; Osteopathic Manual Medicine; Other Names: Sub-Occipital Release; Rib-Raising; Stellate Ganglion Release
Sham Comparator: All Techniques-S; Sham Osteopathic Manual Medicine	Other: Sham; Osteopathic Manual Medicine; Other Names: Sham sub-occipital release; Sham stellate ganglion release; Sham rib raising
Sham Comparator: Sub-Occipital Release-S; Sham Osteopathic Manual Medicine	Other: Sham; Osteopathic Manual Medicine; Other Names: Sham sub-occipital release; Sham stellate ganglion release; Sham rib raising
Sham Comparator: Rib-Raising-S; Sham Osteopathic Manual Medicine	Other: Sham; Osteopathic Manual Medicine; Other Names: Sham sub-occipital release; Sham stellate ganglion release; Sham rib raising
Sham Comparator: Stellate Ganglion Release -S; Sham Osteopathic Manual Medicine	Other: Sham; Osteopathic Manual Medicine; Other Names: Sham sub-occipital release; Sham stellate ganglion release; Sham rib raising

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: New York Institute of Technology
• Investigators: Principal Investigator: Jayme D Mancini, PhD, DO, New York Institute of Technology, College of Osteopathic Medicine; Principal Investigator: Theodore Flaum, DO, New York Institute of Technology, College of Osteopathic Medicine

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): May 1, 2018
• Study Completion (Actual): May 1, 2018

Study Registration Dates

• First Submitted: July 15, 2014
• First Submitted That Met QC Criteria: July 15, 2014
• First Posted (Estimate): July 17, 2014

Study Record Updates

• Last Update Posted (Actual): July 5, 2019
• Last Update Submitted That Met QC Criteria: July 1, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Autonomic Nervous System; Heart Rate Variability; Osteopathic Manipulative Medicine; Sub-Occipital Release; Rib-Raising; Stellate Ganglion Release
• Other Study ID Numbers: BHS-1044