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
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
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
NCT ID
NCT03142373
First Posted
April 28, 2017
Last Updated
March 11, 2019
Sponsor
Fondazione Don Carlo Gnocchi Onlus
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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