HealthyNCT05895149
Effects of Osteopathy in Autonomic Nervous System
A study testing Flying buttress technique in people with Healthy, run by Escola Superior de Tecnologia da Saúde do Porto at 1 site in Portugal.
Trial summary
The most important regulatory system in the body is the autonomic nervous system. There are several studies that evaluate the effect of techniques applied at the base of the skull on the autonomic nervous system. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Flying buttress technique
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Sep 2023to 31 Jul 2024
- 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
- Volunteers between 18 and 35 years of age;
- Ability to maintain a supine position for 30 minutes;
- Healthy volunteers.
Who cannot join
- Presence of acute or chronic pain;
- Recent cranial and/or cervical injury;
- History of cranial and/or cervical surgery;
- Oncological disease;
- Brain injury;
- Cardiovascular pathology;
Show all 14Show fewer
- Neurological pathology;
- Psychological/emotional disorder;
- Pregnancy;
- Manual therapy treatment in the last month;
- Consumption of alcohol, drugs, tobacco, chocolate, and sodas in the last 48 hours;
- Consumption of caffeine on the day of the study;
- Extreme physical exercise in the last 24 hours;
- Less than 6 hours of sleep on the night preceding the study.
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Escola Superior de Saúde do Instituto Politécnico do Porto
Porto, Porto District, 4200-072
About this study
Official title: Effects of Osteopathy in Autonomic Nervous System: a Double-blind Randomized Controlled Trial
The most important regulatory system in the body is the autonomic nervous system. There are several studies that evaluate the effect of techniques applied at the base of the skull on the autonomic nervous system. The aim of this study is to evaluate the effect of the flying buttress technique on the autonomic nervous system.
Read the detailed description
The most important homeostatic regulatory system in the body is the autonomic nervous system (ANS), as it coordinates functions of many organs and tissues, including the cardiac muscle.
ANS regulation in most visceral organs reflects a balance between sympathetic and parasympathetic modulation. In the neural control of the heart, there is a balance between sympathetic excitation and vagal inhibition of sinoatrial node activity, which contribute to fluctuations in heartbeat, known as heart rate variability (HRV).
HRV is considered a valuable non-invasive measurement tool for assessing ANS function, as it is relatively simple and quickly performed.
Previous studies provide evidence that osteopathic treatment is associated with changes in HRV that appear to be indicative of increased cardiac vagal modulation in various conditions.
The aim of this study is to evaluate the effect of the osteopathic technique flying buttress on the ANS through HRV.
- Conditions
- Healthy
- Being tested
- Flying buttress technique, Placebo technique
- Keywords
- Autonomic nervous system, Heart rate variability, Osteopathy, Flying buttress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flying buttress techniqueOther
With the volunteer in a supine position, the researcher who applied the technique positioned himself standing at the head of the massage table, supporting the patient's head. He contacted the occipital region, near the occipital-mastoid suture, with the thenar and hypothenar region of his right hand. He contacted the mastoid process of the contralateral temporal bone with the thenar and hypothenar region of his left hand. The forearms were positioned in a straight line. After a slight initial compression, the researcher applied a rhythmic pumping motion with both upper limbs in a convergent direction. The pressure applied was due to the rhythmic movement of the researcher's body. The technique was performed bilaterally and each one lasted for 2 minutes
Placebo techniqueOther
With the volunteer in a supine position, the researcher placed the palms of their hands on the patient's shoulders. The palm of the hand rested on the acromioclavicular joint with the rest of the hand relaxed. The placebo technique was performed for 4 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | In each participant, HRV will be measured for 2 minutes, then the flying buttress technique will be applied. After the technique, HRV will be recorded for 2 minutes, and 5 minutes later, HRV will be measured again for 2 minutes. Receives: Other: Flying buttress technique |
| Control group | Placebo comparator | In each participant, HRV will be measured for 2 minutes, then the placebo technique will be applied. After the technique, HRV will be recorded for 2 minutes, and 5 minutes later, HRV will be measured again for 2 minutes. Receives: Other: Placebo technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in HRV at immediately post-intervention
The R-R intervals will be collected using a Polar H10 chest strap (Polar Electro Oy, Kempele, Finland), and subsequently, the rMSSD and pNN50 value will be calculated using Software Kubios HRV Standard, version 3.5.0 (Biosignal Analysis and Medical Imaging Group, Department of Physics, University of Kuopio, Kuopio, Finland)
Measured: immediately post-intervention
Change from baseline in HRV at 7 min post-intervention
The R-R intervals will be collected using a Polar H10 chest strap (Polar Electro Oy, Kempele, Finland), and subsequently, the rMSSD and pNN50 value will be calculated using Software Kubios HRV Standard, version 3.5.0 (Biosignal Analysis and Medical Imaging Group, Department of Physics, University of Kuopio, Kuopio, Finland)
Measured: 7 min post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2023
- Study start1 Sep 2023
- Primary completion1 May 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Escola Superior de Tecnologia da Saúde do Porto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Natália Maria Oliveira Campelo, Escola Superior de Tecnologia da Saúde do Porto
- Investigators
- Natália MO Campelo, PhD, Principal investigator, Escola Superior de Saúde do Instituto Politécnico do Porto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05895149
- Sponsor's protocol ID
- OST1-005
- Status last verified
- Dec 2024
- First submitted
- 25 May 2023
- Last updated
- 11 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gibbons CH. Basics of autonomic nervous system function. Handb Clin Neurol. 2019;160:407-418. doi: 10.1016/B978-0-444-64032-1.00027-8.
PubMed 31277865Laborde S, Mosley E, Thayer JF. Heart Rate Variability and Cardiac Vagal Tone in Psychophysiological Research - Recommendations for Experiment Planning, Data Analysis, and Data Reporting. Front Psychol. 2017 Feb 20;8:213. doi: 10.3389/fpsyg.2017.00213. eCollection 2017.
PubMed 28265249McCraty R, Shaffer F. Heart Rate Variability: New Perspectives on Physiological Mechanisms, Assessment of Self-regulatory Capacity, and Health risk. Glob Adv Health Med. 2015 Jan;4(1):46-61. doi: 10.7453/gahmj.2014.073.
PubMed 25694852Ricard, F. (2014). Tratado de Osteopatía Craneal. Articulación Temporomandibular. Análisis y tratamiento ortodóntico. (E. Medos, Ed. 3ª ed.).
Shaffer F, Ginsberg JP. An Overview of Heart Rate Variability Metrics and Norms. Front Public Health. 2017 Sep 28;5:258. doi: 10.3389/fpubh.2017.00258. eCollection 2017.
PubMed 29034226Munoz ML, van Roon A, Riese H, Thio C, Oostenbroek E, Westrik I, de Geus EJ, Gansevoort R, Lefrandt J, Nolte IM, Snieder H. Validity of (Ultra-)Short Recordings for Heart Rate Variability Measurements. PLoS One. 2015 Sep 28;10(9):e0138921. doi: 10.1371/journal.pone.0138921. eCollection 2015.
PubMed 26414314Arienti C, Farinola F, Ratti S, Dacco S, Fasulo L. Variations of HRV and skin conductance reveal the influence of CV4 and Rib Raising techniques on autonomic balance: A randomized controlled clinical trial. J Bodyw Mov Ther. 2020 Oct;24(4):395-401. doi: 10.1016/j.jbmt.2020.07.002. Epub 2020 Jul 31.
PubMed 33218540Cardoso-de-Mello-E-Mello-Ribeiro AP, Rodriguez-Blanco C, Riquelme-Agullo I, Heredia-Rizo AM, Ricard F, Oliva-Pascual-Vaca A. Effects of the Fourth Ventricle Compression in the Regulation of the Autonomic Nervous System: A Randomized Control Trial. Evid Based Complement Alternat Med. 2015;2015:148285. doi: 10.1155/2015/148285. Epub 2015 Jun 14.
PubMed 26199632Carnevali L, Lombardi L, Fornari M, Sgoifo A. Exploring the Effects of Osteopathic Manipulative Treatment on Autonomic Function Through the Lens of Heart Rate Variability. Front Neurosci. 2020 Oct 7;14:579365. doi: 10.3389/fnins.2020.579365. eCollection 2020.
PubMed 33117124Curi ACC, Maior Alves AS, Silva JG. Cardiac autonomic response after cranial technique of the fourth ventricle (cv4) compression in systemic hypertensive subjects. J Bodyw Mov Ther. 2018 Jul;22(3):666-672. doi: 10.1016/j.jbmt.2017.11.013. Epub 2017 Dec 9.
PubMed 30100295Tarvainen MP, Niskanen JP, Lipponen JA, Ranta-Aho PO, Karjalainen PA. Kubios HRV--heart rate variability analysis software. Comput Methods Programs Biomed. 2014;113(1):210-20. doi: 10.1016/j.cmpb.2013.07.024. Epub 2013 Aug 6.
PubMed 24054542Schaffarczyk M, Rogers B, Reer R, Gronwald T. Validity of the Polar H10 Sensor for Heart Rate Variability Analysis during Resting State and Incremental Exercise in Recreational Men and Women. Sensors (Basel). 2022 Aug 30;22(17):6536. doi: 10.3390/s22176536.
PubMed 36081005
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Osteopathy in Autonomic Nervous System: a Double-blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05895149
- Acronym / sponsor ID
- OST1-005
- Conditions
- Healthy
- Keywords
- Autonomic nervous system, Heart rate variability, Osteopathy, Flying buttress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Escola Superior de Tecnologia da Saúde do PortoUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 8 Jun 2023 (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 most important regulatory system in the body is the autonomic nervous system. There are several studies that evaluate the effect of techniques applied at the base of the skull on the autonomic nervous system. The aim of this study is to evaluate the effect of the flying buttress technique on the autonomic nervous system.
Detailed description
The most important homeostatic regulatory system in the body is the autonomic nervous system (ANS), as it coordinates functions of many organs and tissues, including the cardiac muscle.
ANS regulation in most visceral organs reflects a balance between sympathetic and parasympathetic modulation. In the neural control of the heart, there is a balance between sympathetic excitation and vagal inhibition of sinoatrial node activity, which contribute to fluctuations in heartbeat, known as heart rate variability (HRV).
HRV is considered a valuable non-invasive measurement tool for assessing ANS function, as it is relatively simple and quickly performed.
Previous studies provide evidence that osteopathic treatment is associated with changes in HRV that appear to be indicative of increased cardiac vagal modulation in various conditions.
The aim of this study is to evaluate the effect of the osteopathic technique flying buttress on the ANS through HRV.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Flying buttress techniqueIn each participant, HRV will be measured for 2 minutes, then the flying buttress technique will be applied. After the technique, HRV will be recorded for 2 minutes, and 5 minutes later, HRV will be measured again for 2 minutes. |
| Control group | Placebo comparator | Other: Placebo techniqueIn each participant, HRV will be measured for 2 minutes, then the placebo technique will be applied. After the technique, HRV will be recorded for 2 minutes, and 5 minutes later, HRV will be measured again for 2 minutes. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Volunteers between 18 and 35 years of age;
- Ability to maintain a supine position for 30 minutes;
- Healthy volunteers.
Key exclusion criteria (14 listed)
- Presence of acute or chronic pain;
- Recent cranial and/or cervical injury;
- History of cranial and/or cervical surgery;
- Oncological disease;
- Brain injury;
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 |
|---|---|---|
| Flying buttress techniqueWith the volunteer in a supine position, the researcher who applied the technique positioned himself standing at the head of the massage table, supporting the patient's head. He contacted the occipital region, near the occipital-mastoid suture, with the thenar and hypothenar region of his right hand. He contacted the mastoid process of the contralateral temporal bone with the thenar and hypothenar region of his left hand. The forearms were positioned in a straight line. After a slight initial compression, the researcher applied a rhythmic pumping motion with both upper limbs in a convergent direction. The pressure applied was due to the rhythmic movement of the researcher's body. The technique was performed bilaterally and each one lasted for 2 minutes | Other | Experimental group |
| Placebo techniqueWith the volunteer in a supine position, the researcher placed the palms of their hands on the patient's shoulders. The palm of the hand rested on the acromioclavicular joint with the rest of the hand relaxed. The placebo technique was performed for 4 minutes. | Other | Control group |
Primary outcome
Change from baseline in HRV at immediately post-intervention
Time frame: immediately post-intervention
The R-R intervals will be collected using a Polar H10 chest strap (Polar Electro Oy, Kempele, Finland), and subsequently, the rMSSD and pNN50 value will be calculated using Software Kubios HRV Standard, version 3.5.0 (Biosignal Analysis and Medical Imaging Group, Department of Physics, University of Kuopio, Kuopio, Finland)
Change from baseline in HRV at 7 min post-intervention
Time frame: 7 min post-intervention
The R-R intervals will be collected using a Polar H10 chest strap (Polar Electro Oy, Kempele, Finland), and subsequently, the rMSSD and pNN50 value will be calculated using Software Kubios HRV Standard, version 3.5.0 (Biosignal Analysis and Medical Imaging Group, Department of Physics, University of Kuopio, Kuopio, Finland)
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 11 Feb 2025.
- Background: PubMed 31277865Gibbons CH. Basics of autonomic nervous system function. Handb Clin Neurol. 2019;160:407-418. doi: 10.1016/B978-0-444-64032-1.00027-8.
- Background: PubMed 28265249Laborde S, Mosley E, Thayer JF. Heart Rate Variability and Cardiac Vagal Tone in Psychophysiological Research - Recommendations for Experiment Planning, Data Analysis, and Data Reporting. Front Psychol. 2017 Feb 20;8:213. doi: 10.3389/fpsyg.2017.00213. eCollection 2017.
- Background: PubMed 25694852McCraty R, Shaffer F. Heart Rate Variability: New Perspectives on Physiological Mechanisms, Assessment of Self-regulatory Capacity, and Health risk. Glob Adv Health Med. 2015 Jan;4(1):46-61. doi: 10.7453/gahmj.2014.073.
- BackgroundRicard, F. (2014). Tratado de Osteopatía Craneal. Articulación Temporomandibular. Análisis y tratamiento ortodóntico. (E. Medos, Ed. 3ª ed.).
- Background: PubMed 29034226Shaffer F, Ginsberg JP. An Overview of Heart Rate Variability Metrics and Norms. Front Public Health. 2017 Sep 28;5:258. doi: 10.3389/fpubh.2017.00258. eCollection 2017.
- Background: PubMed 26414314Munoz ML, van Roon A, Riese H, Thio C, Oostenbroek E, Westrik I, de Geus EJ, Gansevoort R, Lefrandt J, Nolte IM, Snieder H. Validity of (Ultra-)Short Recordings for Heart Rate Variability Measurements. PLoS One. 2015 Sep 28;10(9):e0138921. doi: 10.1371/journal.pone.0138921. eCollection 2015.
- Results publication: PubMed 33218540Arienti C, Farinola F, Ratti S, Dacco S, Fasulo L. Variations of HRV and skin conductance reveal the influence of CV4 and Rib Raising techniques on autonomic balance: A randomized controlled clinical trial. J Bodyw Mov Ther. 2020 Oct;24(4):395-401. doi: 10.1016/j.jbmt.2020.07.002. Epub 2020 Jul 31.
- Results publication: PubMed 26199632Cardoso-de-Mello-E-Mello-Ribeiro AP, Rodriguez-Blanco C, Riquelme-Agullo I, Heredia-Rizo AM, Ricard F, Oliva-Pascual-Vaca A. Effects of the Fourth Ventricle Compression in the Regulation of the Autonomic Nervous System: A Randomized Control Trial. Evid Based Complement Alternat Med. 2015;2015:148285. doi: 10.1155/2015/148285. Epub 2015 Jun 14.
- Results publication: PubMed 33117124Carnevali L, Lombardi L, Fornari M, Sgoifo A. Exploring the Effects of Osteopathic Manipulative Treatment on Autonomic Function Through the Lens of Heart Rate Variability. Front Neurosci. 2020 Oct 7;14:579365. doi: 10.3389/fnins.2020.579365. eCollection 2020.
- Results publication: PubMed 30100295Curi ACC, Maior Alves AS, Silva JG. Cardiac autonomic response after cranial technique of the fourth ventricle (cv4) compression in systemic hypertensive subjects. J Bodyw Mov Ther. 2018 Jul;22(3):666-672. doi: 10.1016/j.jbmt.2017.11.013. Epub 2017 Dec 9.
- Results publication: PubMed 24054542Tarvainen MP, Niskanen JP, Lipponen JA, Ranta-Aho PO, Karjalainen PA. Kubios HRV--heart rate variability analysis software. Comput Methods Programs Biomed. 2014;113(1):210-20. doi: 10.1016/j.cmpb.2013.07.024. Epub 2013 Aug 6.
- Results publication: PubMed 36081005Schaffarczyk M, Rogers B, Reer R, Gronwald T. Validity of the Polar H10 Sensor for Heart Rate Variability Analysis during Resting State and Incremental Exercise in Recreational Men and Women. Sensors (Basel). 2022 Aug 30;22(17):6536. doi: 10.3390/s22176536.
- Individual participant dataSharing planned: No
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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.
Natália MO Campelo, PhD principal investigator
Escola Superior de Saúde do Instituto Politécnico do Porto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flying buttress technique in people with Healthy, run by Escola Superior de Tecnologia da Saúde do Porto at 1 site in Portugal.
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 14 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 11 Feb 2025. 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 Portugal. 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?
Change from baseline in HRV at immediately post-intervention (time frame: immediately post-intervention). The study lists 2 primary outcomes in all. 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 NCT05895149, which also lists 12 linked publications.
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 11 Feb 2025.