Effects of Osteopathy in Autonomic Nervous System: a Double-blind Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 41
- Locations
- 1
- Primary Endpoint
- Change from baseline in HRV at 7 min post-intervention
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Double (Participant, Outcomes Assessor)
Masking Description
Each participant will pull from a bag within equally number of folded papers with letter 1 to 50 and it will be handled to the investigator. The even numbers correspond to the control group and the odd numbers to the experimental group.
Eligibility Criteria
- Ages
- 18 Years to 35 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Experimental group
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.
Intervention: Flying buttress technique (Other)
Control group
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.
Intervention: Placebo technique (Other)
Outcomes
Primary Outcomes
Change from baseline in HRV at 7 min post-intervention
Time Frame: 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)
Change from baseline in HRV at immediately post-intervention
Time Frame: 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)
Secondary Outcomes
No secondary outcomes reported
Investigators
Natália Maria Oliveira Campelo
Professor
Escola Superior de Tecnologia da Saúde do Porto