Effects of Osteopathy in Autonomic Nervous System

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effects of Osteopathy in Autonomic Nervous System: a Double-blind Randomized Controlled Trial

Conditions
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Healthy

Intervention / Treatment
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* Other: Flying buttress technique
* Other: Placebo technique


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>In each participant, HRV will be measured for 2 minutes, then the flying buttress technique will be applied. After the technique, HRV will be recorded for 2 minutes, and 5 minutes later, HRV will be measured again for 2 minutes. | Other: Flying buttress technique<br>* 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<br>|
| Placebo Comparator: Control group<br>In each participant, HRV will be measured for 2 minutes, then the placebo technique will be applied. After the technique, HRV will be recorded for 2 minutes, and 5 minutes later, HRV will be measured again for 2 minutes. | Other: Placebo technique<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Autonomic nervous system, Heart rate variability, Osteopathy, Flying buttress