Effect of CV4 and Rib Raising Techniques on Autonomic Balance
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
1 other identifier
interventional
48
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2010
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
April 28, 2017
CompletedFirst Posted
Study publicly available on registry
May 5, 2017
CompletedMarch 13, 2019
March 1, 2019
5 months
April 28, 2017
March 11, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Heart Rate Variability
HRV was measured using a heart rate monitor Polar S810i frequency meter
1200 seconds
Secondary Outcomes (1)
Skin Conductance
1200 seconds
Study Arms (3)
CV4 group
EXPERIMENTALCV4 technique
RR group
EXPERIMENTALRib Raising technique
Placebo group
PLACEBO COMPARATORLight touch
Interventions
Eligibility Criteria
You may qualify if:
- healthy subjects
- between 18-65 years old
- both gender
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Officials
- PRINCIPAL INVESTIGATOR
Chiara Arienti, PhD
IRCCS Don Gnocchi Foundation
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr
Study Record Dates
First Submitted
April 28, 2017
First Posted
May 5, 2017
Study Start
June 1, 2010
Primary Completion
November 1, 2010
Study Completion
January 1, 2011
Last Updated
March 13, 2019
Record last verified: 2019-03