Osteopathic Manipulative Treatment and Its Relationship to Autonomic Nervous System Activity
1 other identifier
interventional
30
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable healthy
Started Jan 2005
Longer than P75 for not_applicable healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2005
CompletedFirst Submitted
Initial submission to the registry
August 15, 2007
CompletedFirst Posted
Study publicly available on registry
August 16, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2007
CompletedAugust 22, 2008
August 1, 2008
August 15, 2007
August 21, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Treatments administered in separate sessions at least 24 hours apart.
Study Arms (3)
Placebo
PLACEBO COMPARATORNo-touch control condition applied while subject was at a 50-degree head-up tilt.
Sham
SHAM COMPARATORTouch-only sham treatment applied while subject was at a 50-degree head-up tilt.
OMT
ACTIVE COMPARATORCervical myofascial OMT applied while subject was at a 50-degree head-up tilt.
Interventions
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
OSU
Tulsa, Oklahoma, 74107, United States
Related Publications (1)
Henley CE, Ivins D, Mills M, Wen FK, Benjamin BA. Osteopathic manipulative treatment and its relationship to autonomic nervous system activity as demonstrated by heart rate variability: a repeated measures study. Osteopath Med Prim Care. 2008 Jun 5;2:7. doi: 10.1186/1750-4732-2-7.
PMID: 18534024DERIVED
MeSH Terms
Interventions
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 15, 2007
First Posted
August 16, 2007
Study Start
January 1, 2005
Study Completion
October 1, 2007
Last Updated
August 22, 2008
Record last verified: 2008-08