AzTrials
AzTrials

HealthyNCT00516984

Osteopathic Manipulative Treatment and Its Relationship to Autonomic Nervous System Activity

A study testing OMT in people with Healthy, run by University of Oklahoma at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 19 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
OMT
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
1 siteUnited States
Study dates
Jan 2005to Oct 2007
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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).

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • OSU

    Tulsa, Oklahoma, 74107

Other trials in United States

About this study

Official title: Osteopathic Manipulative Treatment and Its Relationship to Autonomic Nervous System Activity as Demonstrated by Heart Rate Variability

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.

Read the detailed description

For most osteopathic physicians the validation of osteopathic manipulative treatment (OMT) has been largely observational and based on patient outcomes such as improvement in pain scales, range of motion, and other empiric measures.1,2 However, the osteopathic profession has long recognized a relationship between the autonomic nervous system and the function of the body in health and disease, although there is relatively little quantitative data evaluating the relationship between manipulation and the autonomic nervous system.3,4

A theoretical basis for the action of OMT and its effect in the body has been advanced based on autonomic activation causing concomitant vasodilatation, smooth muscle relaxation, and increased blood flow, resulting in improved range of motion, decrease in pain perception, or change in tissue. Until recently this association remained largely a theoretical consideration due to the inability to accurately measure autonomic activity directly. Over the past two decades indirect methods have been developed and refined to provide noninvasive markers of autonomic balance,5,6 with heart rate variability (HRV) being commonly used. HRV is based on the inherent variation of the R-to-R intervals of a standard electrocardiogram (ECG), with these variations largely due to changes in autonomic balance at the sinus node.6-8

Spectral analysis of heart rate variability has been used to study autonomic balance in humans, and it is generally accepted that the high frequency (HF) component (0.15-0.4 Hz) can be used as a marker for vagal modulation of heart rate. Although it is tempting to use the low frequency (LF) component (0.04-0.15 Hz) as a marker for sympathetic activity, its specificity is less clear. Pagani and colleagues9,10 have hypothesized that when the LF component is expressed in normalized units (LFnu) it becomes a better marker of sympathetic modulation of heart rate. For most studies using spectral analysis, the LF/HF ratio is used and considered by many to be a good index of sympathovagal balance.6,7,9,10

The confidence given to the LF/HF ratio accurately reflecting autonomic balance is significantly influenced by experimental design. A tilt protocol involving postural change from horizontal to upright can be used to calibrate the change in the LF/HF ratio which occurs between the two positions and thus set a physiological range for sympathetic and vagal modulation of heart rate. An experimental procedure then can be implemented where comparisons are made of the changes in the LF/HF ratios that occur when the body is shifted from the horizontal to the upright position under conditions with application of an intervention versus without the intervention. In this manner, an experimentally mediated change in LF/HF ratio (i.e., with intervention) can be calibrated against a physiologically relevant change in ratio (i.e., without intervention).

This approach was used by these investigators in a pilot study (n=9 healthy, adult volunteers, 3 females and 6 males) which showed that the LF/HF ratio changed from a mean of 1.75+1.40 (mean+SD) in the horizontal position to a mean of 6.00+1.20 in the 50-degree head-up position. This change reflects an increase in sympathetic tone. Mean heart rate in these subjects increased from 61+7 bpm to 78+2 bpm in the head-up position. The subjects then were treated in the 50-degree head-up position with an OMT procedure, cervical myofascial release, which is thought to increase vagal tone. After the procedure was applied, the LF/HF ratio decreased back down to 1.75+1.58, even though the subjects were still in the head-up position. These data support the initial hypothesis that specific OMT procedures can modulate vagal tone, and also provide information relating to the significance of the LF/HF change. That is, the application of OMT reversed the increase in the ratio that occurs in the 50-degree head-up position.

We conducted a continuation project to further examine the association between OMT and autonomic nervous system activity as demonstrated by HRV, studying the hypothesis that cervical myofascial release increased vagal tone. In a within subjects (repeated measures) design, we examined the effect of OMT on HRV in comparison with sham treatment (touch only) and control (no touch) conditions.

Conditions
Healthy
Being tested
Placebo, Sham, OMT
Keywords
Relationship between Osteopathic Manipulative Therapy (OMT) and the autonomic nervous system, LF/HF ratio

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboProcedure or surgery

    No-touch control condition applied while subject was at a 50-degree head-up tilt.

  • ShamProcedure or surgery

    Touch-only sham treatment applied while subject was at a 50-degree head-up tilt.

  • OMTProcedure or surgery

    Cervical myofascial OMT applied while subject was at a 50-degree head-up tilt.

Study groups in NCT00516984
Study groupRoleWhat they receive
PlaceboPlacebo comparatorNo-touch control condition applied while subject was at a 50-degree head-up tilt.
Receives: Procedure: Placebo
ShamSham comparatorTouch-only sham treatment applied while subject was at a 50-degree head-up tilt.
Receives: Procedure: Sham
OMTActive comparatorCervical myofascial OMT applied while subject was at a 50-degree head-up tilt.
Receives: Procedure: OMT

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Treatments administered in separate sessions at least 24 hours apart.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Aug 2007 (estimated)
  2. Study startJan 2005
  3. Study completionOct 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00516984
Sponsor's protocol ID
OUIRB 12024
Status last verified
Aug 2008
First submitted
15 Aug 2007
Last updated
22 Aug 2008
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 18534024

Questions about this trial

What is this clinical trial studying?

A study testing OMT in people with Healthy, run by University of Oklahoma at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00516984, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2008.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in