Autonomic Nervous System ImbalanceNCT03888456
Effects of OMT on ANS: a Thermography Study
A study testing osteopathic treatment in people with Autonomic Nervous System Imbalance and Healthy, run by Come Collaboration at 1 site in Italy.
Trial summary
the study will investigate the effect of a specific type of touch intervention on the activity of autonomic nervous system measured using thermography Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Autonomic Nervous System Imbalance, Healthy
- What is being tested?
- osteopathic treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 26 Mar 2019to 23 Jul 2019
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- adults above 18y and below 35y
- without any congenital, genetical and chronic disease
- without any symptomatology
Who cannot join
- congenital, genetical and chronic disease
- neurological, cardiovascular, psychiatric disease
- acute pain
- paediatric patients
- adults over 35 years old
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Osteopathic Manipulative Treatment on Autonomic Nervous System: a Thermography Study
the study will investigate the effect of a specific type of touch intervention on the activity of autonomic nervous system measured using thermography
- Conditions
- Autonomic Nervous System Imbalance, Healthy
- Being tested
- osteopathic treatment, sham
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
osteopathic treatmentOther
the intervention will be based on 2 phases: 1) assessment to identify areas with somatic dysfunction, 2) treatment to improve the function of the area identified
shamOther
the sham intervention will consists of 2 overlapping phases as the intervention group but without applying any technique
| Study group | Role | What they receive |
|---|---|---|
| study | Experimental | participants will receive a single touch intervention based on osteopathic assessment and treatment Receives: Other: osteopathic treatment; Other: sham |
| Control | Sham comparator | participants will receive a single touch sham intervention mimicking the intervention Receives: Other: osteopathic treatment; Other: sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
temperature
variability of the autonomic nervous system measured by temperature variability of the face
Measured: 1 week
Secondary outcomes (2)
skin conductance
pre-post changes of physiological parameter of electrodermal skin response
Measured: 1 week
heart rate variability
pre-post changes of HRV
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2019
- Study start26 Mar 2019
- Primary completion30 Jun 2019
- Study completion23 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Autonomic Nervous System ImbalanceStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- randomised placebo controlled crossover study
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Come Collaboration
- Sponsor type
- University, hospital or other
- Collaborators
- Università degli Studi 'G. d'Annunzio' Chieti e Pescara, Chinesis IFOP
- Responsible party
- Sponsor
- Investigators
- Francesco Cerritelli, Principal investigator, Come Collaboration
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03888456
- Sponsor's protocol ID
- COME-02-18
- Status last verified
- Jul 2019
- First submitted
- 21 Mar 2019
- Last updated
- 24 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cerritelli F, Cardone D, Pirino A, Merla A, Scoppa F. Does Osteopathic Manipulative Treatment Induce Autonomic Changes in Healthy Participants? A Thermal Imaging Study. Front Neurosci. 2020 Aug 18;14:887. doi: 10.3389/fnins.2020.00887. eCollection 2020.
PubMed 33013294
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Osteopathic Manipulative Treatment on Autonomic Nervous System: a Thermography Study
- ClinicalTrials.gov ID
- NCT03888456
- Acronym / sponsor ID
- COME-02-18
- Conditions
- Autonomic Nervous System Imbalance, Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Come CollaborationUniversity, hospital or other
- Collaborators
- Università degli Studi 'G. d'Annunzio' Chieti e Pescara, Chinesis IFOP
- Study start
- 26 Mar 2019 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 23 Jul 2019 (actual)
- First posted
- 25 Mar 2019 (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.
the study will investigate the effect of a specific type of touch intervention on the activity of autonomic nervous system measured using thermography
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- randomised placebo controlled crossover study
| Arm | Type | Receives |
|---|---|---|
| study | Experimental | Other: osteopathic treatment, Other: shamparticipants will receive a single touch intervention based on osteopathic assessment and treatment |
| Control | Sham comparator | Other: osteopathic treatment, Other: shamparticipants will receive a single touch sham intervention mimicking the intervention |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- adults above 18y and below 35y
- without any congenital, genetical and chronic disease
- without any symptomatology
Key exclusion criteria (5 listed)
- congenital, genetical and chronic disease
- neurological, cardiovascular, psychiatric disease
- acute pain
- paediatric patients
- adults over 35 years old
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 |
|---|---|---|
| osteopathic treatmentthe intervention will be based on 2 phases: 1) assessment to identify areas with somatic dysfunction, 2) treatment to improve the function of the area identified | Other | Control, study |
| shamthe sham intervention will consists of 2 overlapping phases as the intervention group but without applying any technique | Other | Control, study |
Primary outcome
temperature
Time frame: 1 week
variability of the autonomic nervous system measured by temperature variability of the face
2 secondary outcomes
skin conductance
Time frame: 1 week
heart rate variability
Time frame: 1 week
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 24 Jul 2019.
- Derived from this study: PubMed 33013294Cerritelli F, Cardone D, Pirino A, Merla A, Scoppa F. Does Osteopathic Manipulative Treatment Induce Autonomic Changes in Healthy Participants? A Thermal Imaging Study. Front Neurosci. 2020 Aug 18;14:887. doi: 10.3389/fnins.2020.00887. eCollection 2020.
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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.
Francesco Cerritelli principal investigator
Come Collaboration
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing osteopathic treatment in people with Autonomic Nervous System Imbalance and Healthy, run by Come Collaboration at 1 site in Italy.
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 5 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 24 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
temperature (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03888456, which also lists 1 linked publication.
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 24 Jul 2019.