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

NCT04391777 | Not Yet Recruiting DMC

• 1 other identifier: OST1- 002
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Young Adults

Keywords

Osteopathy; Fourth ventricle compression technique; Physiological variables

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  15 minutes after the intervention.

Secondary Outcomes (8)

• Change from Baseline in respiratory rate variability immediately after the intervention

  Immediately after the intervention.

• Change from Baseline in respiratory rate variability 15 minutes after the intervention

  15 minutes after the intervention

• Change from Baseline in blood pressure variability immediately after the intervention

  Immediately after the intervention.

• Change from Baseline in blood pressure variability 15 minutes after the intervention

  15 minutes after the intervention.

• Change from Baseline in skin conductivity variability immediately after the intervention

  Immediately after the intervention.

Study Arms (2)

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.

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.

Other: Sham

Interventions

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.

CV-4 group

Sham 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.

Control group

Eligibility Criteria

• Age: 18 Years - 33 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy participants aged between 18 and 33 years.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Escola Superior de Tecnologia da Saúde do Porto: lead

Study Sites (1)

Escola Superior da Saúde do Porto

Porto, 4200-072, Portugal

Location

Related Publications (7)

• 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.

  PMID: 22182954 RESULT

• 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.

  PMID: 26199632 RESULT

• 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

  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.

  PMID: 15750368 RESULT

• 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.

  PMID: 23768271 RESULT

• 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.

  PMID: 30100295 RESULT

• 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.

  PMID: 31383430 RESULT

MeSH Terms

Interventions

salicylhydroxamic acid

Study Officials

• Natália MO Campelo

  Escola Superior de Saúde do Politécnico do Porto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Natália MO Campelo, PhD

CONTACT

938674365; ncampelo.estsp.ipp.pt@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 13, 2020
• First Posted: May 18, 2020
• Study Start: September 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: April 2, 2024

Record last verified: 2024-04

Locations

PT (1)