Clinical trial NCT01908920: Osteopathic Manipulative Treatment Effects on High Frequency Parameters in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Subject
Heart Rate Variability
Lead sponsor: European Institute for Evidence Based Osteopathic Medicine
Sponsor class: OTHER
First posted: 2013-07-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.


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;
* Osteopathic treatment during the last 3 months.

Primary outcomes:
measure: Change from baseline high frequency (HF) value at 1 week
timeFrame: baseline and 1 week
Secondary outcomes:
measure: Change from baseline in low frequency (LF) value at 1 week
timeFrame: baseline and 1 week
measure: Change from baseline LF/HF ratio value at 1 week
timeFrame: baseline and 1 week
measure: Change from baseline very low frequency (VLF) value at 1 week
timeFrame: baseline and 1 week
measure: Change from baseline standard deviation beat-to-beat (SDNN) value at 1 week
timeFrame: baseline and 1 week
measure: Changes from baseline square root of the mean squared difference of successive beat-to-beat (RMSSD) at 1 week
timeFrame: baseline and 1 week
measure: Change from baseline proportion of beat-to-beat50 divided by total number of beat-to-beats in (pNN50) at 1 week
timeFrame: baseline and 1 week
measure: Change from baseline detrended fluctuation scaling exponent (DFAa1) value at 1 week
timeFrame: baseline and 1 week
measure: Change in LF value
timeFrame: during treatment session
measure: Change in LF/HF ratio value
timeFrame: during treatment session
measure: Change in VLF value
timeFrame: during treatment session
measure: Change in SDNN value
timeFrame: during treatment session
measure: Change in RMSSD value
timeFrame: during treatment session
measure: Change in pNN50 value
timeFrame: during treatment session
measure: Change in DFAa1 value
timeFrame: during treatment session
measure: Change from baseline intrasubject HF value at 1 week
timeFrame: baseline and 1 week
measure: Change from baseline heart rate variability parameters between smokers and no-smokers at 1 week
timeFrame: baseline and 1 week
measure: Change from baseline 15D questionnaire at 1 week
timeFrame: baseline and 1 week
measure: Differences in skin conductance value between groups
timeFrame: 1 week
Other outcomes:
Locations:
city: Pescara
country: Italy
facility: Accademia Italiana Osteopatia Tradizionale
Study officials:
affiliation: Italian Academy of Traditional Osteopathy - AIOT
name: Francesco Cerritelli, MS, DO
role: STUDY_CHAIR
References:
citation: Ruffini N, D'Alessandro G, Mariani N, Pollastrelli A, Cardinali L, Cerritelli F. Variations of high frequency parameter of heart rate variability following osteopathic manipulative treatment in healthy subjects compared to control group and sham therapy: randomized controlled trial. Front Neurosci. 2015 Aug 4;9:272. doi: 10.3389/fnins.2015.00272. eCollection 2015.