Clinical trial NCT02193373: Study of Osteopathic Manipulative Medicine on the Autonomic Nervous System
Official title: What is the Best Osteopathic Manipulative Medicine (OMM) Approach to Affect Autonomic Nervous System (ANS) Control of Heart Rate Variability (HRV)?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: New York Institute of Technology
Sponsor class: OTHER
First posted: 2014-07-17
Enrollment: 126
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in Heart Rate Variability
timeFrame: one hour
Secondary outcomes:
measure: Effect of Diet and sleep on Heart Rate Variability
timeFrame: Three days
Other outcomes:
Locations:
city: Old Westbury
country: United States
facility: New York Institute of Technology College of Osteopathic Medicine Academic Health Care Center
state: New York
Study officials:
affiliation: New York Institute of Technology, College of Osteopathic Medicine
name: Jayme D Mancini, PhD, DO
role: PRINCIPAL_INVESTIGATOR
affiliation: New York Institute of Technology, College of Osteopathic Medicine
name: Theodore Flaum, DO
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.