Effect of CV4 and Rib Raising Techniques on Autonomic Balance

Not Applicable

Completed

• Conditions: Autonomic Nervous System Disease; Osteopathy
• Interventions: Other: Placebo treatment; Other: CV4 technique; Other: RR technique

• Registration Number: NCT03142373
• Lead Sponsor: Fondazione Don Carlo Gnocchi Onlus

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06
• Primary Completion: 2010-11
• Study Completion: 2011-01
• Study First Submitted: 2017-04-28
• Study First Submitted QC: 2017-05-03
• Study First Posted: 2017-05-05
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-11
• Last Update Posted: 2019-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo group	Placebo treatment	Light touch
CV4 group	CV4 technique	CV4 technique
RR group	RR technique	Rib Raising technique

Primary Outcome Measures

Name	Time	Method
Heart Rate Variability	1200 seconds	HRV was measured using a heart rate monitor Polar S810i frequency meter

Secondary Outcome Measures

Name	Time	Method
Skin Conductance	1200 seconds	SC was measured using a Onda Scanner Domiana (OSD-Microsale model).