Osteopathic Manipulative Treatment Effects on High Frequency Parameters in Healthy Subjects

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 Overview

• Status: Completed
• Conditions: Heart Rate Variability; Healthy Subject
• Intervention / Treatment: Other: Osteopathic manipulative treatment; Other: SHAM; Other: CONTROL

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Pescara, Italy
    • Accademia Italiana Osteopatia Tradizionale

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: OMT; Each osteopathic session is based on structural evaluation and treatment using indirect techniques.	Other: Osteopathic manipulative treatment
Other: 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.	Other: SHAM
Other: CONTROL; No intervention	Other: CONTROL

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline high frequency (HF) value at 1 week	baseline and 1 week

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: European Institute for Evidence Based Osteopathic Medicine
• Investigators: Study Chair: Francesco Cerritelli, MS, DO, Italian Academy of Traditional Osteopathy - AIOT

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): September 1, 2013
• Study Completion (Actual): September 1, 2013

Study Registration Dates

• First Submitted: July 19, 2013
• First Submitted That Met QC Criteria: July 23, 2013
• First Posted (Estimate): July 26, 2013

Study Record Updates

• Last Update Posted (Estimate): September 10, 2013
• Last Update Submitted That Met QC Criteria: September 8, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Other Study ID Numbers: HRVOST