Osteopathic Manipulative Treatment Effects on High Frequency Parameters in Healthy Subjects

Heart Rate Variability Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01908920
• Other study ID #: HRVOST
• Status: Completed
• Phase: N/A
• First received: July 19, 2013
• Last updated: September 8, 2013
• Start date: May 2013
• Est. completion date: September 2013

Study information

• Verified date: September 2013
• Source: European Institute for Evidence Based Osteopathic Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor)

Related Conditions & MeSH terms

• Healthy Subject
• Heart Rate Variability

Intervention

Other:
• Osteopathic manipulative treatment

• SHAM

• CONTROL

Locations

Country	Name	City	State
Italy	Accademia Italiana Osteopatia Tradizionale	Pescara

Sponsors (1)

Lead Sponsor	Collaborator
European Institute for Evidence Based Osteopathic Medicine

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline high frequency (HF) value at 1 week		baseline and 1 week	No
Secondary	Change from baseline in low frequency (LF) value at 1 week		baseline and 1 week	No
Secondary	Change from baseline LF/HF ratio value at 1 week		baseline and 1 week	No
Secondary	Change from baseline very low frequency (VLF) value at 1 week		baseline and 1 week	No
Secondary	Change from baseline standard deviation beat-to-beat (SDNN) value at 1 week		baseline and 1 week	No
Secondary	Changes from baseline square root of the mean squared difference of successive beat-to-beat (RMSSD) at 1 week		baseline and 1 week	No
Secondary	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	No
Secondary	Change from baseline detrended fluctuation scaling exponent (DFAa1) value at 1 week		baseline and 1 week	No
Secondary	Change in LF value		during treatment session	No
Secondary	Change in LF/HF ratio value		during treatment session	No
Secondary	Change in VLF value		during treatment session	No
Secondary	Change in SDNN value		during treatment session	No
Secondary	Change in RMSSD value		during treatment session	No
Secondary	Change in pNN50 value		during treatment session	No
Secondary	Change in DFAa1 value		during treatment session	No
Secondary	Change from baseline intrasubject HF value at 1 week		baseline and 1 week	No
Secondary	Change from baseline heart rate variability parameters between smokers and no-smokers at 1 week		baseline and 1 week	No
Secondary	Change from baseline 15D questionnaire at 1 week		baseline and 1 week	No
Secondary	Differences in skin conductance value between groups		1 week	No