Clinical Trial: Effect of CV4 and Rib Raising Techniques on Autonomic Balance

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Variations of Heart Rate Variability and Skin Conductance Reveal the Influence of CV4 and Rib Raising Osteopathic Techniques on the Autonomic Nervous System: a Randomized Controlled Trial

Brief Summary:

Background. Heart rate variability (HRV) and skin conductance (SC) reflect autonomic activity and the balance of autonomic nervous system (ANS) which regulates involuntary physiological functions. The modulation of ANS tonic activity is a target of osteopathic manipulative treatment (OMT). The main aim of the present study was to verify whether CV4 and RR osteopathic techniques influence ANS activity, as measured by HRV and SC.

Trial design. A randomized-controlled clinical trial was performed from June 2010 to January 2011.

Methods. 32 healthy adults (33.9±14 years, and 72% female) were selected. At enrollment, all subjects were randomized in three groups: CV4 group (CV4 technique), Rib Raising group (RR technique), and Placebo group (PL technique). Each subject of each group underwent respective technique only once. HRV and SC was continuously recorded during the session respectively with heart rate monitor Polar S810i and with Onda Scanner Domiana (OSD-Microsale model). All data analysis was performed using SPSS statistical software and the significance level was considered at p≤0.05.


Detailed Summary:
Sponsor: Fondazione Don Carlo Gnocchi Onlus

Current Primary Outcome: Heart Rate Variability [ Time Frame: 1200 seconds ]

HRV was measured using a heart rate monitor Polar S810i frequency meter attached to a belt. An encoded transmitter was placed on the thoracic region at the fifth intercostal space.


Original Primary Outcome: Same as current

Current Secondary Outcome: Skin Conductance [ Time Frame: 1200 seconds ]

SC was amplified using a Onda Scanner Domiana (OSD-Microsale model), an instrument that measures electrical skin conductance (SC) through two terminals (silver electrodes with gel saline) with continuous voltage placed on the wrists of the patients.


Original Secondary Outcome: Same as current

Information By: Fondazione Don Carlo Gnocchi Onlus

Dates:
Date Received: April 28, 2017
Date Started: June 2010
Date Completion:
Last Updated: May 3, 2017
Last Verified: May 2017