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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 22, 2014