Osteopathic Manipulative Treatment Effects on High Frequency Parameters in Healthy Subjects

Not Applicable

Completed

• Conditions: Healthy Subject; Heart Rate Variability
• Interventions: Other: Osteopathic manipulative treatment; Other: SHAM; Other: CONTROL

• Registration Number: NCT01908920
• Lead Sponsor: European Institute for Evidence Based Osteopathic Medicine

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-07-19
• Study First Submitted QC: 2013-07-23
• Study First Posted: 2013-07-26
• Status Verified: 2013-09
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Last Update Submitted: 2013-09-08
• Last Update Posted: 2013-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OMT	Osteopathic manipulative treatment	Each osteopathic session is based on structural evaluation and treatment using indirect techniques.
SHAM	SHAM	Sham therapy was administered with subjects lying supine on the treatment table while the operator used light manual contact to "treat" the subject. A pre-determined protocol has been used. The practitioner's attention was distracted by subtracting calculation in silence.
CONTROL	CONTROL	No intervention

Primary Outcome Measures

Name	Time	Method
Change from baseline high frequency (HF) value at 1 week	baseline and 1 week

Secondary Outcome Measures

Name	Time	Method
Change in RMSSD value	during treatment session
Change in pNN50 value	during treatment session
Change in DFAa1 value	during treatment session
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 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

Trial Locations

Locations (1)

Accademia Italiana Osteopatia Tradizionale; 🇮🇹 Pescara, Italy