Effect of CV4 and Rib Raising Techniques on Autonomic Balance

Sponsor

Fondazione Don Carlo Gnocchi Onlus (Other)

Overall Status

Completed

CT.gov ID

NCT03142373

Collaborator

(none)

Enrollment

Arms

Actual Duration (Months)

Study Details

Study Description

Brief Summary

Background. Heart rate variability (HRV) and skin conductance (SC) highlight 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.

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

Methods. 32 healthy adults were selected. At enrollment, all healthy subjects were randomized in three groups: CV4 group (CV4 technique), Rib Raising group (RR technique), and Placebo group (PL technique). HRV and SC was 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 set at p≤0.05.

Condition or Disease	Intervention/Treatment	Phase
Autonomic Nervous System Disease Osteopathy	Other: CV4 technique Other: RR technique Other: Placebo treatment	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

48 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jun 1, 2010

Actual Primary Completion Date :

Nov 1, 2010

Actual Study Completion Date :

Jan 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CV4 group CV4 technique	Other: CV4 technique
Experimental: RR group Rib Raising technique	Other: RR technique
Placebo Comparator: Placebo group Light touch	Other: Placebo treatment

Arm

Intervention/Treatment

Experimental: CV4 group

CV4 technique

Other: CV4 technique

Experimental: RR group

Rib Raising technique

Other: RR technique

Placebo Comparator: Placebo group

Light touch

Other: Placebo treatment

Outcome Measures

Primary Outcome Measures

Heart Rate Variability [1200 seconds]
HRV was measured using a heart rate monitor Polar S810i frequency meter

Secondary Outcome Measures

Skin Conductance [1200 seconds]
SC was measured using a Onda Scanner Domiana (OSD-Microsale model).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

healthy subjects
between 18-65 years old
both gender

Exclusion Criteria:

BMI ≥ 30
pregnancy
menstrual flow during the session
chronic pain
chronic drug treatment
presence of skin, cardiovascular, psychiatric and neurological diseases
medical history of surgical interventions
OMT in the previous 3 months

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Fondazione Don Carlo Gnocchi Onlus

Investigators

Principal Investigator: Chiara Arienti, PhD, IRCCS Don Gnocchi Foundation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Chiara Arienti, Dr, Fondazione Don Carlo Gnocchi Onlus

ClinicalTrials.gov Identifier:

NCT03142373

Other Study ID Numbers:

OMT and HRV

First Posted:

May 5, 2017

Last Update Posted:

Mar 13, 2019

Last Verified:

Mar 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Chiara Arienti, Dr, Fondazione Don Carlo Gnocchi Onlus

heart rate variability

autonomic nervous system

osteopathic manipulative treatment

skin conductance

Additional relevant MeSH terms:

Nervous System Diseases

Autonomic Nervous System Diseases

Primary Dysautonomias

Study Results

No Results Posted as of Mar 13, 2019