Effect of CV4 and Rib Raising Techniques on Autonomic Balance

NCT ID: NCT03142373

Last Updated: 2019-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2011-01-31

Brief Summary

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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

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Conditions

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Autonomic Nervous System Disease Osteopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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CV4 group

CV4 technique

Group Type EXPERIMENTAL

CV4 technique

Intervention Type OTHER

RR group

Rib Raising technique

Group Type EXPERIMENTAL

RR technique

Intervention Type OTHER

Placebo group

Light touch

Group Type PLACEBO_COMPARATOR

Placebo treatment

Intervention Type OTHER

Interventions

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CV4 technique

Intervention Type OTHER

RR technique

Intervention Type OTHER

Placebo treatment

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fondazione Don Carlo Gnocchi Onlus

OTHER

Sponsor Role lead

Responsible Party

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Chiara Arienti

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chiara Arienti, PhD

Role: PRINCIPAL_INVESTIGATOR

IRCCS Don Gnocchi Foundation

Other Identifiers

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OMT and HRV

Identifier Type: -

Identifier Source: org_study_id

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