NCT01908920CompletedNot Applicable
Osteopathic Manipulative Treatment Effects on High Frequency Parameters in Healthy Subjects
European Institute for Evidence Based Osteopathic Medicine1 site in 1 country60 target enrollmentStarted: May 1, 2013Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Change from baseline high frequency (HF) value at 1 week
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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;
- •Osteopathic treatment during the last 3 months.
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)
Investigators
Francesco Cerritelli
MS, DO
European Institute for Evidence Based Osteopathic Medicine
Study Sites (1)
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