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Completed

NCT Number: NCT05895149

Effects of Osteopathy in Autonomic Nervous System

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.

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Key information

Conditions

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Escola Superior de Saúde do Instituto Politécnico do Porto

Porto, Porto District, 4200-072, Portugal

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Flying buttress technique

Other

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

Other

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.

Primary outcomes

  1. 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)

  2. 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)

Sponsors and collaborators

Lead sponsor

Escola Superior de Tecnologia da Saúde do Porto

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 8, 2023
Registry last updated
Feb 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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