Autonomic Nervous System DiseaseNCT03142373
Effect of CV4 and Rib Raising Techniques on Autonomic Balance
A study testing CV4 technique and RR technique in people with Autonomic Nervous System Disease and Osteopathy, run by Fondazione Don Carlo Gnocchi ETS.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Autonomic Nervous System Disease, Osteopathy
- What is being tested?
- CV4 technique and RR technique
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- Jun 2010to Jan 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy subjects
- between 18-65 years old
- both gender
Who cannot join
- 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
About this study
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
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.
- Conditions
- Autonomic Nervous System Disease, Osteopathy
- Being tested
- CV4 technique, RR technique, Placebo treatment
- Keywords
- heart rate variability, autonomic nervous system, osteopathic manipulative treatment, skin conductance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CV4 techniqueOther
RR techniqueOther
Placebo treatmentOther
| Study group | Role | What they receive |
|---|---|---|
| CV4 group | Experimental | CV4 technique Receives: Other: CV4 technique |
| RR group | Experimental | Rib Raising technique Receives: Other: RR technique |
| Placebo group | Placebo comparator | Light touch Receives: Other: Placebo treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart Rate Variability
HRV was measured using a heart rate monitor Polar S810i frequency meter
Measured: 1200 seconds
Secondary outcomes (1)
Skin Conductance
SC was measured using a Onda Scanner Domiana (OSD-Microsale model).
Measured: 1200 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2017
- Study startJun 2010
- Primary completionNov 2010
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autonomic Nervous System DiseaseStudies of the same condition, open and under way.
- More trials run by Fondazione Don Carlo Gnocchi ETSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETS
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chiara Arienti, Fondazione Don Carlo Gnocchi ETS
- Investigators
- Chiara Arienti, PhD, Principal investigator, IRCCS Don Gnocchi Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03142373
- Sponsor's protocol ID
- OMT and HRV
- Status last verified
- Mar 2019
- First submitted
- 28 Apr 2017
- Last updated
- 13 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03142373
- Acronym / sponsor ID
- OMT and HRV
- Conditions
- Autonomic Nervous System Disease, Osteopathy
- Keywords
- heart rate variability, autonomic nervous system, osteopathic manipulative treatment, skin conductance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETSUniversity, hospital or other
- Study start
- Jun 2010 (actual)
- Primary completion
- Nov 2010 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 5 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CV4 group | Experimental | Other: CV4 techniqueCV4 technique |
| RR group | Experimental | Other: RR techniqueRib Raising technique |
| Placebo group | Placebo comparator | Other: Placebo treatmentLight touch |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- healthy subjects
- between 18-65 years old
- both gender
Key exclusion criteria (8 listed)
- BMI ≥ 30
- pregnancy
- menstrual flow during the session
- chronic pain
- chronic drug treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CV4 technique | Other | CV4 group |
| RR technique | Other | RR group |
| Placebo treatment | Other | Placebo group |
Primary outcome
Heart Rate Variability
Time frame: 1200 seconds
HRV was measured using a heart rate monitor Polar S810i frequency meter
1 secondary outcome
Skin Conductance
Time frame: 1200 seconds
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chiara Arienti, PhD principal investigator
IRCCS Don Gnocchi Foundation
Questions about this trial
What is this clinical trial studying?
A study testing CV4 technique and RR technique in people with Autonomic Nervous System Disease and Osteopathy, run by Fondazione Don Carlo Gnocchi ETS.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart Rate Variability (time frame: 1200 seconds). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2019.