Healthy Young AdultsNCT04391777
Determine the Effect of the Fourth Ventricle Compression Technique on Physiological Variables
A study testing Fourth ventricle compression technique (CV-4) in people with Healthy Young Adults, run by Escola Superior de Tecnologia da Saúde do Porto at 1 site in Portugal.
Trial summary
This study aims to analyze the influence of the fourth ventricle compression technique in heart rate, respiratory rate, blood pressure, conductivity and thermal variability of the skin in healthy young adults. Read more about this study
- Who is it for?
- Ages 18 to 33 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Young Adults
- What is being tested?
- Fourth ventricle compression technique (CV-4)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 sitePortugal
- Study dates
- Sep 2024to Dec 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 33 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy participants aged between 18 and 33 years.
Who cannot join
- Cognitive deficits that can possibly compromise the understanding of the study instructions;
- Any type of medication taken that may have influences at the variables under study in the previous 7 days;
- Cranio-cervical injuries, surgery to the skull and /or spine in the last 12 months;
- Chronic cardiorespiratory, renal, systemic, neurological, musculoskeletal, oncological and psychiatric pathologies;
- Headaches, migraines, dizziness and / or nausea while performing the techniques;
- Caffeine and / or alcohol intake in the 6 hours prior to the data collection;
Show all 11Show fewer
- Tobacco consumption in the 30 minutes prior to the data collection;
- Practice of intense physical exercise in the 90 minutes prior to the data collection;
- Pregnant women or menstruating;
- Participants who were submitted to manual therapy treatments during the past month;
- Osteopathy students of 3rd year or higher degree, in order to prevent the participant from recognizing which group they belong to.
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Escola Superior da Saúde do Porto
Porto, 4200-072
Natália MO Campelo, +351 938 674 365, ncampelo.estsp.ipp@gmail.com
Natália MO Campelo
About this study
Official title: Determine the Effect of the Fourth Ventricle Compression Technique on Heart Rate, Respiratory Rate, Blood Pressure, Thermal Variation and Skin Conductivity in Healthy Young Adults: a Randomized Clinical Study
This study aims to analyze the influence of the fourth ventricle compression technique in heart rate, respiratory rate, blood pressure, conductivity and thermal variability of the skin in healthy young adults.
Read the detailed description
The fourth ventricle compression technique (CV-4) is one of the most important techniques in the treatment of cranial osteopathy.
During the present study, the effects of CV-4 technique will be analyzed in the following variables: heart rate, respiratory rate, blood pressure, conductivity and thermal variation of the skin.
According to the literature, CV-4 technique will cause changes in all of the studied variables, except the respiratory rate, through the activation of the brain stem, namely the parasympathetic nerve centers.
Regarding the respiratory rate, it is justified by the fourth ventricle and the respiratory centers proximity.
Concerning heart rate and respiratory rate, during the CV-4 technique the literature describes a decrease in the values of this variables. However, other studies refer that the technique does not produce relevant effects in the heart and respiratory rates variation, probably because there was no stipulated time to finish the technique, ending subjectively compared to previous ones.
When it comes to blood pressure, a decrease in systolic blood pressure values is noticed by some authors.
In which concerns the variation in body temperature, according to the literature, there were no significant results obtained when performing CV-4.
During the performed literature analysis,there were not found any studies concerning the influences of the CV-4 technique in the thermal conductivity variable.
- Conditions
- Healthy Young Adults
- Being tested
- Fourth ventricle compression technique (CV-4), Sham
- Keywords
- Osteopathy, Fourth ventricle compression technique, Physiological variables
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fourth ventricle compression technique (CV-4)Other
The participant is in the supine position and the principal investigator is seated at the patient's head, with elbows resting on the table. The main investigator overlaps his hands with the thenar eminences, contacting the occipital bone squamous part, between the external occipital protuberance and the participant's occipito-mastoid suture. The technique begins with a maintained compression on the occipital squamous part during a deep thorax exhalation. Throughout the compression of the occipital bone and the participant's voluntary inspirations, the principal investigator feels a gradual pressure increase at the thenar eminences. The technique will be performed until reaching the still point, in which the mobility of the occipital bone, respiratory rate and muscle tone decrease, or until 5 minutes elapsed.
ShamOther
The main investigator uses the technique contact but does not perform any type of tissue traction or compression, maintaining this contact for 5 minutes. At the end of the stipulated time, the contact is removed in a subtle way.
| Study group | Role | What they receive |
|---|---|---|
| CV-4 group | Experimental | The initial selection will be made through a questionnaire, in order to fulfill the exclusion and inclusion criteria. On the data collection day a more detailed survey is performed and informed consent is signed.
The patient waits for 5 minutes in the supine position, after which the baseline evaluation is performed.
The CV-4 technique is performed following immediate evaluation. 15 minutes after the technique, a new evaluation of the variables is accomplished. Receives: Other: Fourth ventricle compression technique (CV-4) |
| Control group | Sham comparator | The initial selection will be made through a questionnaire, in order to fulfill the exclusion and inclusion criteria. On the data collection day a more detailed survey is performed and informed consent is signed.
The patient waits for 5 minutes in the supine position, after which the baseline evaluation is performed.
The sham technique is performed following immediate evaluation. 15 minutes after the technique, a new evaluation of the variables is accomplished. Receives: Other: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in heart rate variability immediately after the intervention
To obtain the heart rate measurements, a pulse volume sensor (Biosignalsplux researcher) was connected to the third finger of the hand, with the patient lying supine. The sensor was only removed after completing all the evaluation moments.
Measured: Immediately after the intervention.
Change from Baseline in heart rate variability 15 minutes after the intervention
To obtain the heart rate measurements, a pulse volume sensor (Biosignalsplux researcher) was connected to the third finger of the hand, with the patient lying supine. The sensor was only removed after completing all the evaluation moments.
Measured: 15 minutes after the intervention.
Secondary outcomes (8)
Change from Baseline in respiratory rate variability immediately after the intervention
To obtain the respiratory rate measurements, a respiratory belt transducer (Biopac Systems) was adjusted to the patient's thorax, at the xiphoid process level, with the patient lying supine. The sensor was only removed after completing all the evaluation moments.
Measured: Immediately after the intervention.
Change from Baseline in respiratory rate variability 15 minutes after the intervention
To obtain the respiratory rate measurements, a respiratory belt transducer (Biopac Systems) was adjusted to the patient's thorax, at the xiphoid process level, with the patient lying supine. The sensor was only removed after completing all the evaluation moments.
Measured: 15 minutes after the intervention
Change from Baseline in blood pressure variability immediately after the intervention
To obtain the blood pressure measurements, a digital sphygmomanometer was applied to the patient's left arm, with the patient lying supine. The sensor was only removed after completing all the evaluation moments.
Measured: Immediately after the intervention.
Change from Baseline in blood pressure variability 15 minutes after the intervention
To obtain the blood pressure measurements, a digital sphygmomanometer was applied to the patient's left arm, with the patient lying supine. The sensor was only removed after completing all the evaluation moments.
Measured: 15 minutes after the intervention.
Change from Baseline in skin conductivity variability immediately after the intervention
To obtain the skin conductivity measurements, 2 electrodermal activity sensors (Biosignalsplux researcher) were connected to the patient's first finger, on the carpometacarpal and metacarpophalangeal joints, with the patient lying supine. The sensor was only removed after completing all the evaluation moments.
Measured: Immediately after the intervention.
Change from Baseline in skin conductivity variability 15 minutes after the intervention
To obtain the skin conductivity measurements, 2 electrodermal activity sensors (Biosignalsplux researcher) were connected to the patient's first finger, on the carpometacarpal and metacarpophalangeal joints, with the patient lying supine. The sensor was only removed after completing all the evaluation moments.
Measured: 15 minutes after the intervention.
Change from Baseline in skin thermal variation immediately after the intervention
To obtain the skin thermal variation measurements, negative temperature coefficient (NTC) thermistor sensors (Biosignalsplux researcher) were connected to the patient's first finger, on the carpometacarpal and metacarpophalangeal joints, with the patient lying supine. The sensor was only removed after completing all the evaluation moments.
Measured: Immediately after the intervention.
Change from Baseline in skin thermal variation 15 minutes after the intervention
To obtain the skin thermal variation measurements, negative temperature coefficient (NTC) thermistor sensors (Biosignalsplux researcher) were connected to the patient's first finger, on the carpometacarpal and metacarpophalangeal joints, with the patient lying supine. The sensor was only removed after completing all the evaluation moments.
Measured: 15 minutes after the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2020
- Study startSep 2024 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Healthy Young AdultsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
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, Principal investigator, Escola Superior de Saúde do Politécnico do Porto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04391777
- Sponsor's protocol ID
- OST1- 002
- Status last verified
- Apr 2024
- First submitted
- 13 May 2020
- Last updated
- 2 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jakel A, von Hauenschild P. Therapeutic effects of cranial osteopathic manipulative medicine: a systematic review. J Am Osteopath Assoc. 2011 Dec;111(12):685-93.
PubMed 22182954Cardoso-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 26199632Milnes, K., & Moran, R. W. (2007). Physiological effects of a CV4 cranial osteopathic technique on autonomic nervous system function: A preliminary investigation. International Journal of Osteopathic Medicine, 10(1), 8-17. https://doi.org/10.1016/j.ijosm.2007.01.003
Cutler MJ, Holland BS, Stupski BA, Gamber RG, Smith ML. Cranial manipulation can alter sleep latency and sympathetic nerve activity in humans: a pilot study. J Altern Complement Med. 2005 Feb;11(1):103-8. doi: 10.1089/acm.2005.11.103.
PubMed 15750368Miana L, Bastos VH, Machado S, Arias-Carrion O, Nardi AE, Almeida L, Ribeiro P, Machado D, King H, Silva JG. Changes in alpha band activity associated with application of the compression of fourth ventricular (CV-4) osteopathic procedure: a qEEG pilot study. J Bodyw Mov Ther. 2013 Jul;17(3):291-6. doi: 10.1016/j.jbmt.2012.10.002. Epub 2012 Nov 16.
PubMed 23768271Curi 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 30100295Bayo-Tallon V, Esquirol-Caussa J, Pamias-Massana M, Planells-Keller K, Palao-Vidal DJ. Effects of manual cranial therapy on heart rate variability in children without associated disorders: Translation to clinical practice. Complement Ther Clin Pract. 2019 Aug;36:125-141. doi: 10.1016/j.ctcp.2019.06.008. Epub 2019 Jul 2.
PubMed 31383430
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determine the Effect of the Fourth Ventricle Compression Technique on Heart Rate, Respiratory Rate, Blood Pressure, Thermal Variation and Skin Conductivity in Healthy Young Adults: a Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT04391777
- Acronym / sponsor ID
- OST1- 002
- Conditions
- Healthy Young Adults
- Keywords
- Osteopathy, Fourth ventricle compression technique, Physiological variables
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Escola Superior de Tecnologia da Saúde do PortoUniversity, hospital or other
- Study start
- Sep 2024 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 18 May 2020 (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.
This study aims to analyze the influence of the fourth ventricle compression technique in heart rate, respiratory rate, blood pressure, conductivity and thermal variability of the skin in healthy young adults.
Detailed description
The fourth ventricle compression technique (CV-4) is one of the most important techniques in the treatment of cranial osteopathy.
During the present study, the effects of CV-4 technique will be analyzed in the following variables: heart rate, respiratory rate, blood pressure, conductivity and thermal variation of the skin.
According to the literature, CV-4 technique will cause changes in all of the studied variables, except the respiratory rate, through the activation of the brain stem, namely the parasympathetic nerve centers.
Regarding the respiratory rate, it is justified by the fourth ventricle and the respiratory centers proximity.
Concerning heart rate and respiratory rate, during the CV-4 technique the literature describes a decrease in the values of this variables. However, other studies refer that the technique does not produce relevant effects in the heart and respiratory rates variation, probably because there was no stipulated time to finish the technique, ending subjectively compared to previous ones.
When it comes to blood pressure, a decrease in systolic blood pressure values is noticed by some authors.
In which concerns the variation in body temperature, according to the literature, there were no significant results obtained when performing CV-4.
During the performed literature analysis,there were not found any studies concerning the influences of the CV-4 technique in the thermal conductivity variable.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CV-4 group | Experimental | Other: Fourth ventricle compression technique (CV-4)The initial selection will be made through a questionnaire, in order to fulfill the exclusion and inclusion criteria. On the data collection day a more detailed survey is performed and informed consent is signed. The patient waits for 5 minutes in the supine position, after which the baseline evaluation is performed. The CV-4 technique is performed following immediate evaluation. 15 minutes after the technique, a new evaluation of the variables is accomplished. |
| Control group | Sham comparator | Other: ShamThe initial selection will be made through a questionnaire, in order to fulfill the exclusion and inclusion criteria. On the data collection day a more detailed survey is performed and informed consent is signed. The patient waits for 5 minutes in the supine position, after which the baseline evaluation is performed. The sham technique is performed following immediate evaluation. 15 minutes after the technique, a new evaluation of the variables is accomplished. |
Who may qualify
- Ages
- 18 to 33 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy participants aged between 18 and 33 years.
Key exclusion criteria (11 listed)
- Cognitive deficits that can possibly compromise the understanding of the study instructions;
- Any type of medication taken that may have influences at the variables under study in the previous 7 days;
- Cranio-cervical injuries, surgery to the skull and /or spine in the last 12 months;
- Chronic cardiorespiratory, renal, systemic, neurological, musculoskeletal, oncological and psychiatric pathologies;
- Headaches, migraines, dizziness and / or nausea while performing the techniques;
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 |
|---|---|---|
| Fourth ventricle compression technique (CV-4)The participant is in the supine position and the principal investigator is seated at the patient's head, with elbows resting on the table. The main investigator overlaps his hands with the thenar eminences, contacting the occipital bone squamous part, between the external occipital protuberance and the participant's occipito-mastoid suture. The technique begins with a maintained compression on the occipital squamous part during a deep thorax exhalation. Throughout the compression of the occipital bone and the participant's voluntary inspirations, the principal investigator feels a gradual pressure increase at the thenar eminences. The technique will be performed until reaching the still point, in which the mobility of the occipital bone, respiratory rate and muscle tone decrease, or until 5 minutes elapsed. | Other | CV-4 group |
| ShamThe main investigator uses the technique contact but does not perform any type of tissue traction or compression, maintaining this contact for 5 minutes. At the end of the stipulated time, the contact is removed in a subtle way. | Other | Control group |
Primary outcome
Change from Baseline in heart rate variability immediately after the intervention
Time frame: Immediately after the intervention.
To obtain the heart rate measurements, a pulse volume sensor (Biosignalsplux researcher) was connected to the third finger of the hand, with the patient lying supine. The sensor was only removed after completing all the evaluation moments.
Change from Baseline in heart rate variability 15 minutes after the intervention
Time frame: 15 minutes after the intervention.
To obtain the heart rate measurements, a pulse volume sensor (Biosignalsplux researcher) was connected to the third finger of the hand, with the patient lying supine. The sensor was only removed after completing all the evaluation moments.
8 secondary outcomes
Change from Baseline in respiratory rate variability immediately after the intervention
Time frame: Immediately after the intervention.
Change from Baseline in respiratory rate variability 15 minutes after the intervention
Time frame: 15 minutes after the intervention
Change from Baseline in blood pressure variability immediately after the intervention
Time frame: Immediately after the intervention.
Change from Baseline in blood pressure variability 15 minutes after the intervention
Time frame: 15 minutes after the intervention.
Change from Baseline in skin conductivity variability immediately after the intervention
Time frame: Immediately after the intervention.
Change from Baseline in skin conductivity variability 15 minutes after the intervention
Time frame: 15 minutes after the intervention.
Change from Baseline in skin thermal variation immediately after the intervention
Time frame: Immediately after the intervention.
Change from Baseline in skin thermal variation 15 minutes after the intervention
Time frame: 15 minutes after the intervention.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2024.
- Results publication: PubMed 22182954Jakel A, von Hauenschild P. Therapeutic effects of cranial osteopathic manipulative medicine: a systematic review. J Am Osteopath Assoc. 2011 Dec;111(12):685-93.
- 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 publicationMilnes, K., & Moran, R. W. (2007). Physiological effects of a CV4 cranial osteopathic technique on autonomic nervous system function: A preliminary investigation. International Journal of Osteopathic Medicine, 10(1), 8-17. https://doi.org/10.1016/j.ijosm.2007.01.003
- Results publication: PubMed 15750368Cutler MJ, Holland BS, Stupski BA, Gamber RG, Smith ML. Cranial manipulation can alter sleep latency and sympathetic nerve activity in humans: a pilot study. J Altern Complement Med. 2005 Feb;11(1):103-8. doi: 10.1089/acm.2005.11.103.
- Results publication: PubMed 23768271Miana L, Bastos VH, Machado S, Arias-Carrion O, Nardi AE, Almeida L, Ribeiro P, Machado D, King H, Silva JG. Changes in alpha band activity associated with application of the compression of fourth ventricular (CV-4) osteopathic procedure: a qEEG pilot study. J Bodyw Mov Ther. 2013 Jul;17(3):291-6. doi: 10.1016/j.jbmt.2012.10.002. Epub 2012 Nov 16.
- 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 31383430Bayo-Tallon V, Esquirol-Caussa J, Pamias-Massana M, Planells-Keller K, Palao-Vidal DJ. Effects of manual cranial therapy on heart rate variability in children without associated disorders: Translation to clinical practice. Complement Ther Clin Pract. 2019 Aug;36:125-141. doi: 10.1016/j.ctcp.2019.06.008. Epub 2019 Jul 2.
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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 principal investigator
Escola Superior de Saúde do 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 Fourth ventricle compression technique (CV-4) in people with Healthy Young Adults, 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 1 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 2 Apr 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Natália MO Campelo, PhD (938674365 ext. +351, ncampelo.estsp.ipp.pt@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in heart rate variability immediately after the intervention (time frame: Immediately after the 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 NCT04391777, which also lists 7 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 2 Apr 2024.