Study of Osteopathic Manipulative Medicine on the Autonomic Nervous System
- Conditions
- Osteopathic Manual Manipulation of Neurovascular Regulation
- Interventions
- Other: Osteopathic Manual MedicineOther: Sham
- Registration Number
- NCT02193373
- Lead Sponsor
- New York Institute of Technology
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 126
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Rib-Raising Osteopathic Manual Medicine Osteopathic Manual Medicine All techniques Osteopathic Manual Medicine Osteopathic Manual Medicine All Techniques-S Sham Sham Osteopathic Manual Medicine Sub-Occipital Release-S Sham Sham Osteopathic Manual Medicine Rib-Raising-S Sham Sham Osteopathic Manual Medicine Stellate Ganglion Release Osteopathic Manual Medicine Osteopathic Manual Medicine Sub-Occipital Release Osteopathic Manual Medicine Osteopathic Manual Medicine Stellate Ganglion Release -S Sham Sham Osteopathic Manual Medicine
- Primary Outcome Measures
Name Time Method Change in Heart Rate Variability one hour 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.
- Secondary Outcome Measures
Name Time Method Effect of Diet and sleep on Heart Rate Variability Three days heart rate
Trial Locations
- Locations (1)
New York Institute of Technology College of Osteopathic Medicine Academic Health Care Center
🇺🇸Old Westbury, New York, United States