Clinical trial NCT05895149: Effects of Osteopathy in Autonomic Nervous System
Official title: Effects of Osteopathy in Autonomic Nervous System: a Double-blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Autonomic nervous system
Heart rate variability
Osteopathy
Flying buttress
Lead sponsor: Escola Superior de Tecnologia da Saúde do Porto
Sponsor class: OTHER
First posted: 2023-06-08
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline in HRV at immediately post-intervention
timeFrame: immediately post-intervention
measure: Change from baseline in HRV at 7 min post-intervention
timeFrame: 7 min post-intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Porto
country: Portugal
facility: Escola Superior de Saúde do Instituto Politécnico do Porto
Study officials:
affiliation: Escola Superior de Saúde do Instituto Politécnico do Porto
name: Natália MO Campelo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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