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Effect of CV4 and Rib Raising Techniques on Autonomic Balance

Primary Purpose

Autonomic Nervous System Disease, Osteopathy

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
CV4 technique
RR technique
Placebo treatment
Sponsored by
Fondazione Don Carlo Gnocchi Onlus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autonomic Nervous System Disease focused on measuring heart rate variability, autonomic nervous system, osteopathic manipulative treatment, skin conductance

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    CV4 group

    RR group

    Placebo group

    Arm Description

    CV4 technique

    Rib Raising technique

    Light touch

    Outcomes

    Primary Outcome Measures

    Heart Rate Variability
    HRV was measured using a heart rate monitor Polar S810i frequency meter

    Secondary Outcome Measures

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

    Full Information

    First Posted
    April 28, 2017
    Last Updated
    March 11, 2019
    Sponsor
    Fondazione Don Carlo Gnocchi Onlus
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03142373
    Brief Title
    Effect of CV4 and Rib Raising Techniques on Autonomic Balance
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2010 (Actual)
    Primary Completion Date
    November 2010 (Actual)
    Study Completion Date
    January 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Fondazione Don Carlo Gnocchi Onlus

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Autonomic Nervous System Disease, Osteopathy
    Keywords
    heart rate variability, autonomic nervous system, osteopathic manipulative treatment, skin conductance

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    48 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    CV4 group
    Arm Type
    Experimental
    Arm Description
    CV4 technique
    Arm Title
    RR group
    Arm Type
    Experimental
    Arm Description
    Rib Raising technique
    Arm Title
    Placebo group
    Arm Type
    Placebo Comparator
    Arm Description
    Light touch
    Intervention Type
    Other
    Intervention Name(s)
    CV4 technique
    Intervention Type
    Other
    Intervention Name(s)
    RR technique
    Intervention Type
    Other
    Intervention Name(s)
    Placebo treatment
    Primary Outcome Measure Information:
    Title
    Heart Rate Variability
    Description
    HRV was measured using a heart rate monitor Polar S810i frequency meter
    Time Frame
    1200 seconds
    Secondary Outcome Measure Information:
    Title
    Skin Conductance
    Description
    SC was measured using a Onda Scanner Domiana (OSD-Microsale model).
    Time Frame
    1200 seconds

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Chiara Arienti, PhD
    Organizational Affiliation
    IRCCS Don Gnocchi Foundation
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    Effect of CV4 and Rib Raising Techniques on Autonomic Balance

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