Healthy Clinical Trial
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.
Status | Not yet recruiting |
Enrollment | 50 |
Est. completion date | July 31, 2024 |
Est. primary completion date | May 1, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 35 Years |
Eligibility | Inclusion Criteria: - Volunteers between 18 and 35 years of age; - Ability to maintain a supine position for 30 minutes; - Healthy volunteers. Exclusion Criteria: - 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; - 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. |
Country | Name | City | State |
---|---|---|---|
Portugal | Escola Superior de Saúde do Instituto Politécnico do Porto | Porto |
Lead Sponsor | Collaborator |
---|---|
Escola Superior de Tecnologia da Saúde do Porto |
Portugal,
Arienti 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: 1 — View 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 Ba — View Citation
Carnevali 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 2 — View 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. — View Citation
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. — View Citation
Laborde 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. — View Citation
McCraty 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. — View Citation
Munoz 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. — View Citation
Ricard, F. (2014). Tratado de Osteopatía Craneal. Articulación Temporomandibular. Análisis y tratamiento ortodóntico. (E. Medos, Ed. 3ª ed.).
Schaffarczyk 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/s2217653 — View Citation
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. — View Citation
Tarvainen 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. — View Citation
* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | immediately post-intervention | |
Primary | 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) | 7 min post-intervention |
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