Determine the Effect of the Fourth Ventricle Compression Technique on Physiological Variables

NCT ID: NCT04391777

Last Updated: 2024-04-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-30

Study Completion Date

2024-12-31

Brief Summary

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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

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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

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Healthy Young Adults

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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CV-4 group

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.

Group Type EXPERIMENTAL

Fourth ventricle compression technique (CV-4)

Intervention Type 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.

Control group

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.

Group Type SHAM_COMPARATOR

Sham

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Sham

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Healthy participants aged between 18 and 33 years.

Exclusion Criteria

* 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;
* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

33 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Escola Superior de Tecnologia da Saúde do Porto

OTHER

Sponsor Role lead

Responsible Party

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Natália Maria Oliveira Campelo

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Natália MO Campelo

Role: PRINCIPAL_INVESTIGATOR

Escola Superior de Saúde do Politécnico do Porto

Locations

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Escola Superior da Saúde do Porto

Porto, , Portugal

Site Status

Countries

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Portugal

Central Contacts

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Natália MO Campelo, PhD

Role: CONTACT

938674365 ext. +351

Facility Contacts

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Natália MO Campelo

Role: primary

+351 938 674 365

References

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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.

Reference Type RESULT
PMID: 22182954 (View on PubMed)

Cardoso-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.

Reference Type RESULT
PMID: 26199632 (View on PubMed)

Milnes, 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

Reference Type RESULT

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.

Reference Type RESULT
PMID: 15750368 (View on PubMed)

Miana 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.

Reference Type RESULT
PMID: 23768271 (View on PubMed)

Curi 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.

Reference Type RESULT
PMID: 30100295 (View on PubMed)

Bayo-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.

Reference Type RESULT
PMID: 31383430 (View on PubMed)

Other Identifiers

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OST1- 002

Identifier Type: -

Identifier Source: org_study_id

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