Effect of CV4 and Rib Raising Techniques on Autonomic Balance

Autonomic Nervous System Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03142373
• Other study ID #: OMT and HRV
• Status: Completed
• Phase: N/A
• Start date: June 2010
• Est. completion date: January 2011

Study information

• Verified date: March 2019
• Source: Fondazione Don Carlo Gnocchi Onlus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: January 2011
• Est. primary completion date: November 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Autonomic Nervous System Disease
• Autonomic Nervous System Diseases
• Nervous System Diseases
• Osteopathy
• Primary Dysautonomias

Intervention

Other:
• CV4 technique

• RR technique

• Placebo treatment

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Don Carlo Gnocchi Onlus

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart Rate Variability	HRV was measured using a heart rate monitor Polar S810i frequency meter	1200 seconds
Secondary	Skin Conductance	SC was measured using a Onda Scanner Domiana (OSD-Microsale model).	1200 seconds