Clinical trial NCT04391777: Determine the Effect of the Fourth Ventricle Compression Technique on Physiological Variables
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Healthy Young Adults
Keywords: Osteopathy
Fourth ventricle compression technique
Physiological variables
Lead sponsor: Escola Superior de Tecnologia da Saúde do Porto
Sponsor class: OTHER
First posted: 2020-05-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 33
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from Baseline in heart rate variability immediately after the intervention
timeFrame: Immediately after the intervention.
measure: Change from Baseline in heart rate variability 15 minutes after the intervention
timeFrame: 15 minutes after the intervention.
Secondary outcomes:
measure: Change from Baseline in respiratory rate variability immediately after the intervention
timeFrame: Immediately after the intervention.
measure: Change from Baseline in respiratory rate variability 15 minutes after the intervention
timeFrame: 15 minutes after the intervention
measure: Change from Baseline in blood pressure variability immediately after the intervention
timeFrame: Immediately after the intervention.
measure: Change from Baseline in blood pressure variability 15 minutes after the intervention
timeFrame: 15 minutes after the intervention.
measure: Change from Baseline in skin conductivity variability immediately after the intervention
timeFrame: Immediately after the intervention.
measure: Change from Baseline in skin conductivity variability 15 minutes after the intervention
timeFrame: 15 minutes after the intervention.
measure: Change from Baseline in skin thermal variation immediately after the intervention
timeFrame: Immediately after the intervention.
measure: Change from Baseline in skin thermal variation 15 minutes after the intervention
timeFrame: 15 minutes after the intervention.
Other outcomes:
Locations:
city: Porto
country: Portugal
facility: Escola Superior da Saúde do Porto
Study officials:
affiliation: Escola Superior de Saúde do Politécnico do Porto
name: Natália MO Campelo
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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
citation: 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.
citation: 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.
citation: 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.
citation: 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.