Osteopathic Manipulative Treatment Effects on High Frequency Parameters in Healthy Subjects

European Institute for Evidence Based Osteopathic Medicine1 site in 1 country60 target enrollmentMay 2013

ConditionsHealthy Subject Heart Rate Variability

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Healthy Subject
Sponsor: European Institute for Evidence Based Osteopathic Medicine
Enrollment: 60
Locations: 1
Primary Endpoint: Change from baseline high frequency (HF) value at 1 week
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The aim of the present study is to determine the extend to which osteopathic manipulative treatment (OMT) is effective on a sample of healthy subjects in changing high frequency (HF) parameters.

Registry

clinicaltrials.gov

Start Date

May 2013

End Date

September 2013

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

European Institute for Evidence Based Osteopathic Medicine

Responsible Party

Principal Investigator

Francesco Cerritelli

MS, DO

European Institute for Evidence Based Osteopathic Medicine

Eligibility Criteria

Inclusion Criteria

•Age between 18 and 45;
•No chronic symptomatology;
•No acute symptomatology during the last 72 hours before intervention;
•No pathologies

Exclusion Criteria

•Age below 18 or over 45;
•Pregnancy;
•Menopause;
•Abuse of alcool during the last 48 hours;
•Chronic pain;
•Acute pain during the last 72 hours;
•Conclamate pathologies;
•Use of drugs during the last 72 hours ;
•Use of ortothic devices during the last 3 months;
•Any type of surgery;

Outcomes

Primary Outcomes

Change from baseline high frequency (HF) value at 1 week

Time Frame: baseline and 1 week

Secondary Outcomes

Change from baseline in low frequency (LF) value at 1 week(baseline and 1 week)
Change from baseline LF/HF ratio value at 1 week(baseline and 1 week)
Change from baseline very low frequency (VLF) value at 1 week(baseline and 1 week)
Change from baseline standard deviation beat-to-beat (SDNN) value at 1 week(baseline and 1 week)
Changes from baseline square root of the mean squared difference of successive beat-to-beat (RMSSD) at 1 week(baseline and 1 week)
Change from baseline proportion of beat-to-beat50 divided by total number of beat-to-beats in (pNN50) at 1 week(baseline and 1 week)
Change from baseline detrended fluctuation scaling exponent (DFAa1) value at 1 week(baseline and 1 week)
Change in LF value(during treatment session)
Change in LF/HF ratio value(during treatment session)
Change in VLF value(during treatment session)
Change in SDNN value(during treatment session)
Change in RMSSD value(during treatment session)
Change in pNN50 value(during treatment session)
Change in DFAa1 value(during treatment session)
Change from baseline intrasubject HF value at 1 week(baseline and 1 week)
Change from baseline heart rate variability parameters between smokers and no-smokers at 1 week(baseline and 1 week)
Change from baseline 15D questionnaire at 1 week(baseline and 1 week)
Differences in skin conductance value between groups(1 week)