- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03142373
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CV4 group
CV4 technique
|
|
Experimental: RR group
Rib Raising technique
|
|
Placebo Comparator: Placebo group
Light touch
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Heart Rate Variability
Time Frame: 1200 seconds
|
HRV was measured using a heart rate monitor Polar S810i frequency meter
|
1200 seconds
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Skin Conductance
Time Frame: 1200 seconds
|
SC was measured using a Onda Scanner Domiana (OSD-Microsale model).
|
1200 seconds
|
Collaborators and Investigators
Investigators
- Principal Investigator: Chiara Arienti, PhD, IRCCS Don Gnocchi Foundation
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- OMT and HRV
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Autonomic Nervous System Disease
-
The Hong Kong Polytechnic UniversityUnknownAutonomic Nervous System DisorderChina
-
Northwell HealthEnrolling by invitationAutonomic Nervous System Diseases | Autonomic Dysfunction | Autonomic Imbalance | Vagus Nerve Autonomic DisorderUnited States
-
Hacettepe UniversityCompletedGastrointestinal Diseases | Autonomic Nervous System DiseaseTurkey
-
Dartmouth-Hitchcock Medical CenterNorris Cotton Cancer Center; ZRT Laboratory; Flight Attendant Medical Research...CompletedPulmonary Disease | COPD | Autonomic DysfunctionUnited States
-
University of ZurichCompletedParkinson's Disease - Autonomic DysregulationSwitzerland
-
National Institute of Neurological Disorders and...CompletedHypertension | Healthy | Autonomic Nervous System DiseaseUnited States
-
Istanbul Medipol University HospitalCompletedVagus Nerve Autonomic DisorderTurkey
-
Virginia Polytechnic Institute and State UniversityNot yet recruiting
-
University of Mississippi Medical CenterVicor Technologies, Inc.CompletedAutonomic DysfunctionUnited States
-
Federal University of Health Science of Porto AlegreCompletedVertebra; Degeneration | Other Disorders of the Autonomic Nervous SystemBrazil
Clinical Trials on CV4 technique
-
Accademia Italiana Medicina OsteopaticaCompleted
-
University of BrasiliaUniversity Hospital of BrasíliaWithdrawn
-
Istituto Superiore di Osteopatia di MilanoCompletedHealthy | Osteopathic ManipulationItaly
-
Western University of Health SciencesCompleted
-
University of BolognaRecruitingAbdominal Aortic Aneurysm | Endovascular Aortic RepairItaly
-
Escola Superior de Tecnologia da Saúde do PortoNot yet recruiting
-
Universidad Autonoma de Baja CaliforniaCompletedPost Operative PainMexico
-
Natália Maria Oliveira CampeloRecruiting
-
Escola Superior de Tecnologia da Saúde do PortoCompletedLatent Myofascial Trigger Point of Upper Trapezius MusclePortugal
-
Zagazig UniversityCompletedLaparoscopic Surgery | Safety Issues | Insufflation | Operative Surgical ProcedureEgypt