Osteopathic Manipulative Treatment and Its Relationship to Autonomic Nervous System Activity

This study has been completed.
Sponsor:
Collaborator:
Oklahoma State University Center for Health Sciences
Information provided by:
University of Oklahoma
ClinicalTrials.gov Identifier:
NCT00516984
First received: August 15, 2007
Last updated: August 21, 2008
Last verified: August 2008
  Purpose

The relationship between Osteopathic Manipulative Therapy (OMT) and the autonomic nervous system is poorly understood. This study quantifies that relationship and demonstrates a cause and effect. It is hypothesized that cervical myofascial release increases vagal tone.


Condition Intervention
Healthy
Procedure: Placebo
Procedure: Sham
Procedure: OMT

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Osteopathic Manipulative Treatment and Its Relationship to Autonomic Nervous System Activity as Demonstrated by Heart Rate Variability

Further study details as provided by University of Oklahoma:

Primary Outcome Measures:
  • Normalized low frequency and high frequency components of HRV, including LF/HF ratio. Comparisons between measurements taken at a 50-degree tilt with those taken at pre- and post-intervention in the horizontal position. [ Time Frame: Treatments administered in separate sessions at least 24 hours apart. ]

Enrollment: 30
Study Start Date: January 2005
Study Completion Date: October 2007
Arms Assigned Interventions
Placebo Comparator: Placebo
No-touch control condition applied while subject was at a 50-degree head-up tilt.
Procedure: Placebo
No-touch control condition applied while subject was at a 50-degree head-up tilt.
Sham Comparator: Sham
Touch-only sham treatment applied while subject was at a 50-degree head-up tilt.
Procedure: Sham
Touch-only sham treatment applied while subject was at a 50-degree head-up tilt.
Active Comparator: OMT
Cervical myofascial OMT applied while subject was at a 50-degree head-up tilt.
Procedure: OMT
Cervical myofascial OMT applied while subject was at a 50-degree head-up tilt.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   19 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Twenty-eight (28) study subjects then were selected by their response to a general questionnaire, which indicated suitability for the study, and assessed by the following inclusion criteria:

  • written informed consent
  • normal healthy adults older than 19 years and younger than 50 years
  • normal ECG
  • normal blood pressure based on criteria published in the Seventh Report of the U.S. Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC-7).

Exclusion Criteria:

  • Exclusion criteria included chronic cardiovascular disease (heart failure, myocardial infarction, or hypertension)
  • diabetes
  • asthma
  • pregnancy
  • smoking
  • premature ventricular contractions exceeding 20% of total heart beats
  • resting supine heart rate greater than 75 bpm or less than 45 bpm, systolic blood pressure greater than 140 mmHg or less than 90 mmHg
  • failure of heart rate to increase with passive tilt (50-degrees head-up)
  • Long-distance runners and other conditioned athletes also were excluded
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00516984

Locations
United States, Oklahoma
OSU
Tulsa, Oklahoma, United States, 74107
Sponsors and Collaborators
University of Oklahoma
Oklahoma State University Center for Health Sciences
Investigators
Principal Investigator: Charles E. Henley, D.O., MPH OUHSC
Principal Investigator: Frances Wen, Ph.D. OUHSC
Principal Investigator: Bruce Benjamin, Ph.D. OSU
Principal Investigator: Douglas Ivins, M.D. OUHSC
Principal Investigator: Miriam Mills, M.D. OSU
  More Information

No publications provided

Responsible Party: Charles Henley, DO, MPH, OU Health Sciences Center - Tulsa
ClinicalTrials.gov Identifier: NCT00516984     History of Changes
Other Study ID Numbers: OUIRB 12024
Study First Received: August 15, 2007
Last Updated: August 21, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by University of Oklahoma:
Relationship between Osteopathic Manipulative Therapy (OMT) and the autonomic nervous system
LF/HF ratio

ClinicalTrials.gov processed this record on April 16, 2014