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Effects of Osteopathy in Autonomic Nervous System

Sponsor
Escola Superior de Tecnologia da Saúde do Porto (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05895149
Collaborator
(none)
50
Enrollment
1
Location
2
Arms
11
Anticipated Duration (Months)
4.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Flying buttress technique
  • Other: Placebo technique
 N/A

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
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
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.
Primary Purpose:
Other
Official Title:
Effects of Osteopathy in Autonomic Nervous System: a Double-blind Randomized Controlled Trial
Anticipated Study Start Date :
Sep 1, 2023
Anticipated Primary Completion Date :
May 1, 2024
Anticipated Study Completion Date :
Jul 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

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 Comparator: 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.

Other: 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.

Outcome Measures

Primary Outcome Measures

  1. Change from baseline in HRV at immediately post-intervention [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 [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 35 Years
Sexes Eligible for Study:
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Escola Superior de Saúde do Instituto Politécnico do Porto Porto Portugal 4200-072

Sponsors and Collaborators

  • Escola Superior de Tecnologia da Saúde do Porto

Investigators

  • Principal Investigator: Natália MO Campelo, PhD, Escola Superior de Saúde do Instituto Politécnico do Porto

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Natália Maria Oliveira Campelo, Professor, Escola Superior de Tecnologia da Saúde do Porto
ClinicalTrials.gov Identifier:
NCT05895149
Other Study ID Numbers:
  • OST1-005
First Posted:
Jun 8, 2023
Last Update Posted:
Jun 8, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Natália Maria Oliveira Campelo, Professor, Escola Superior de Tecnologia da Saúde do Porto
Autonomic nervous system
Heart rate variability
Osteopathy
Flying buttress

Study Results

No Results Posted as of Jun 8, 2023