Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05895149
Other study ID # OST1-005
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date September 1, 2023
Est. completion date July 31, 2024

Study information

Verified date June 2023
Source Escola Superior de Tecnologia da Saúde do Porto
Contact Natália MO Campelo, PhD
Phone 00351 22 206 1000
Email ncampelo.estsp.ipp@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

The most important homeostatic regulatory system in the body is the autonomic nervous system (ANS), as it coordinates functions of many organs and tissues, including the cardiac muscle. ANS regulation in most visceral organs reflects a balance between sympathetic and parasympathetic modulation. In the neural control of the heart, there is a balance between sympathetic excitation and vagal inhibition of sinoatrial node activity, which contribute to fluctuations in heartbeat, known as heart rate variability (HRV). HRV is considered a valuable non-invasive measurement tool for assessing ANS function, as it is relatively simple and quickly performed. Previous studies provide evidence that osteopathic treatment is associated with changes in HRV that appear to be indicative of increased cardiac vagal modulation in various conditions. The aim of this study is to evaluate the effect of the osteopathic technique flying buttress on the ANS through HRV.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Flying buttress technique
With the volunteer in a supine position, the researcher who applied the technique positioned himself standing at the head of the massage table, supporting the patient's head. He contacted the occipital region, near the occipital-mastoid suture, with the thenar and hypothenar region of his right hand. He contacted the mastoid process of the contralateral temporal bone with the thenar and hypothenar region of his left hand. The forearms were positioned in a straight line. After a slight initial compression, the researcher applied a rhythmic pumping motion with both upper limbs in a convergent direction. The pressure applied was due to the rhythmic movement of the researcher's body. The technique was performed bilaterally and each one lasted for 2 minutes
Placebo technique
With the volunteer in a supine position, the researcher placed the palms of their hands on the patient's shoulders. The palm of the hand rested on the acromioclavicular joint with the rest of the hand relaxed. The placebo technique was performed for 4 minutes.

Locations

Country Name City State
Portugal Escola Superior de Saúde do Instituto Politécnico do Porto Porto

Sponsors (1)

Lead Sponsor Collaborator
Escola Superior de Tecnologia da Saúde do Porto

Country where clinical trial is conducted

Portugal, 

References & Publications (12)

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 allClick here to view all references

Outcome

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
See also
  Status Clinical Trial Phase
Recruiting NCT06052553 - A Study of TopSpin360 Training Device N/A
Completed NCT05511077 - Biomarkers of Oat Product Intake: The BiOAT Marker Study N/A
Recruiting NCT04632485 - Early Detection of Vascular Dysfunction Using Biomarkers From Lagrangian Carotid Strain Imaging
Completed NCT05931237 - Cranberry Flavan-3-ols Consumption and Gut Microbiota in Healthy Adults N/A
Completed NCT04527718 - Study of the Safety, Tolerability and Pharmacokinetics of 611 in Adult Healthy Volunteers Phase 1
Terminated NCT04556032 - Effects of Ergothioneine on Cognition, Mood, and Sleep in Healthy Adult Men and Women N/A
Completed NCT04065295 - A Study to Test How Well Healthy Men Tolerate Different Doses of BI 1356225 Phase 1
Completed NCT04998695 - Health Effects of Consuming Olive Pomace Oil N/A
Completed NCT04107441 - AX-8 Drug Safety, Tolerability and Plasma Levels in Healthy Subjects Phase 1
Completed NCT01442831 - Evaluate the Absorption, Metabolism, And Excretion Of Orally Administered [14C] TR 701 In Healthy Adult Male Subjects Phase 1
Terminated NCT05934942 - A Study in Healthy Women to Test Whether BI 1358894 Influences the Amount of a Contraceptive in the Blood Phase 1
Recruiting NCT05525845 - Studying the Hedonic and Homeostatic Regulation of Food Intake Using Functional MRI N/A
Completed NCT05515328 - A Study in Healthy Men to Test How BI 685509 is Processed in the Body Phase 1
Completed NCT05030857 - Drug-drug Interaction and Food-effect Study With GLPG4716 and Midazolam in Healthy Subjects Phase 1
Completed NCT04967157 - Cognitive Effects of Citicoline on Attention in Healthy Men and Women N/A
Recruiting NCT04494269 - A Study to Evaluate Pharmacokinetics and Safety of Tegoprazan in Subjects With Hepatic Impairment and Healthy Controls Phase 1
Recruiting NCT04714294 - Evaluate the Safety, Tolerability and Pharmacokinetics Characteristics of HPP737 in Healthy Volunteers Phase 1
Completed NCT04539756 - Writing Activities and Emotions N/A
Recruiting NCT04098510 - Concentration of MitoQ in Human Skeletal Muscle N/A
Completed NCT03308110 - Bioavailability and Food Effect Study of Two Formulations of PF-06650833 Phase 1