Effects of Osteopathic Technique on Autonomic Nervous System Activity

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

109 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-20

Study Completion Date

2024-11-10

Brief Summary

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Cranial osteopathic manipulation technique for brain and cranial nerve function, known as the fourth ventricle compression (CV4), has been recognized. Rib raising (RR), aimed at reducing rib restriction and conditions associated with sympathetic hypertonia, is also employed. This study aimed to assess, in about 109 healthy individuals, the effects of osteopathic techniques (CV4 and RR) on autonomic nervous system (ANS) activity, as measured by heart rate variability (HRV).

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Detailed Description

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In this planned study, 109 healthy subjects will be randomly assigned to one of three groups. A total of 90-100 participants are expected to complete all stages of the study, and their data will be used in the final analysis. The first experimental group will undergo three 30-minute sessions of osteopathic therapy, including the CV4 and RR techniques. The second group will receive three 30-minute sessions of the CV4 technique alone. The placebo group will undergo a sham procedure using an ultrasound transducer. To evaluate the impact of these osteopathic techniques on autonomic nervous system (ANS) function, Heart Rate Variability (HRV) will be measured using an EEG/HRV/RSA Infiniti 8 device, ProComp Infiniti encoder, and Biograph Infiniti and Physiology Suit software. Measurements will be conducted in a seated position over a 5-minute duration.

Conditions

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Healthy Dysautonomia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

n this study, 109 healthy subjects will be randomly assigned to one of three groups. The first experimental group will receive three 30-minute sessions of osteopathic therapy using both CV4 and RR techniques. The second group will undergo three 30-minute sessions of the CV4 technique alone. The placebo group will undergo a sham procedure using an ultrasound transducer. To assess the impact of these interventions on autonomic nervous system (ANS) function, Heart Rate Variability (HRV) will be measured using specialized equipment in a seated position over a 5-minute duration.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

This study will employ a single-blind design, where participants will be unaware of the specific intervention they receive. However, the investigators and care providers will be informed about the group assignments to ensure proper administration of the interventions. Blinding will be maintained throughout the study to prevent participant bias.

Study Groups

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CV4 + RR Group

Participants will undergo three 30-minute sessions of osteopathic therapy combining the Fourth Ventricle Compression (CV4) and Rib Raising (RR) techniques.

Group Type EXPERIMENTAL

CV4 + RR

Intervention Type PROCEDURE

Participants in this group will undergo three 30-minute sessions of osteopathic therapy. The intervention will involve a combination of the Fourth Ventricle Compression (CV4) technique and the Rib Raising (RR) technique. These sessions will be administered once per week over three consecutive weeks. The CV4 technique involves gentle compression of the occiput to influence cranial rhythmic impulses, while the RR technique involves mobilization of the rib cage to impact autonomic nervous system function.

EEG/HRV/RSA (Electroencephalography, Heart Rate Variability, Respiratory Sinus Arrhythmia) Monitoring using Infiniti System

Intervention Type DEVICE

Participants in this study will undergo monitoring of Heart Rate Variability (HRV), and Respiratory Sinus Arrhythmia (RSA) using the Infiniti 8 measuring device. This system includes a ProComp Infiniti encoder, which is a versatile and advanced tool for capturing physiological signals, and the Biograph Infiniti software, which, along with the Physiology Suit, allows for detailed analysis and monitoring of autonomic nervous system function.

CV4 Group

Participants will receive three 30-minute sessions of osteopathic therapy focusing solely on the Fourth Ventricle Compression (CV4) technique.

Group Type EXPERIMENTAL

CV4

Intervention Type PROCEDURE

Participants in this group will receive three 30-minute sessions focusing solely on the Fourth Ventricle Compression (CV4) technique. The sessions will be conducted once per week for three consecutive weeks. The CV4 technique involves applying gentle pressure to the occiput with the goal of affecting cranial rhythmic impulses and promoting autonomic nervous system balance.

EEG/HRV/RSA (Electroencephalography, Heart Rate Variability, Respiratory Sinus Arrhythmia) Monitoring using Infiniti System

Intervention Type DEVICE

Participants in this study will undergo monitoring of Heart Rate Variability (HRV), and Respiratory Sinus Arrhythmia (RSA) using the Infiniti 8 measuring device. This system includes a ProComp Infiniti encoder, which is a versatile and advanced tool for capturing physiological signals, and the Biograph Infiniti software, which, along with the Physiology Suit, allows for detailed analysis and monitoring of autonomic nervous system function.

Placebo Group

Participants will undergo a sham procedure involving an ultrasound transducer for three 30-minute sessions, with no therapeutic intervention.

Group Type PLACEBO_COMPARATOR

sham ultrasound transducer

Intervention Type DEVICE

Participants in the placebo group will undergo three 30-minute sessions of a sham procedure using an ultrasound transducer. The transducer will be applied in a manner that mimics a therapeutic intervention, but without delivering any actual therapeutic effect. These sessions will also be conducted once per week for three consecutive weeks.

Ultrasound Transducer Sham Procedure

Intervention Type DEVICE

Participants in the placebo group will undergo three 30-minute sessions using an ultrasound transducer as part of a sham procedure. The transducer will be applied to the body in a manner that mimics a therapeutic intervention, but it will not deliver any actual therapeutic effect. This procedure is designed to simulate the experience of receiving treatment without providing the physiological benefits associated with active ultrasound therapy. The sessions will be conducted once per week over three consecutive weeks.

EEG/HRV/RSA (Electroencephalography, Heart Rate Variability, Respiratory Sinus Arrhythmia) Monitoring using Infiniti System

Intervention Type DEVICE

Participants in this study will undergo monitoring of Heart Rate Variability (HRV), and Respiratory Sinus Arrhythmia (RSA) using the Infiniti 8 measuring device. This system includes a ProComp Infiniti encoder, which is a versatile and advanced tool for capturing physiological signals, and the Biograph Infiniti software, which, along with the Physiology Suit, allows for detailed analysis and monitoring of autonomic nervous system function.

Interventions

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CV4 + RR

Participants in this group will undergo three 30-minute sessions of osteopathic therapy. The intervention will involve a combination of the Fourth Ventricle Compression (CV4) technique and the Rib Raising (RR) technique. These sessions will be administered once per week over three consecutive weeks. The CV4 technique involves gentle compression of the occiput to influence cranial rhythmic impulses, while the RR technique involves mobilization of the rib cage to impact autonomic nervous system function.

Intervention Type PROCEDURE

CV4

Participants in this group will receive three 30-minute sessions focusing solely on the Fourth Ventricle Compression (CV4) technique. The sessions will be conducted once per week for three consecutive weeks. The CV4 technique involves applying gentle pressure to the occiput with the goal of affecting cranial rhythmic impulses and promoting autonomic nervous system balance.

Intervention Type PROCEDURE

sham ultrasound transducer

Participants in the placebo group will undergo three 30-minute sessions of a sham procedure using an ultrasound transducer. The transducer will be applied in a manner that mimics a therapeutic intervention, but without delivering any actual therapeutic effect. These sessions will also be conducted once per week for three consecutive weeks.

Intervention Type DEVICE

Ultrasound Transducer Sham Procedure

Participants in the placebo group will undergo three 30-minute sessions using an ultrasound transducer as part of a sham procedure. The transducer will be applied to the body in a manner that mimics a therapeutic intervention, but it will not deliver any actual therapeutic effect. This procedure is designed to simulate the experience of receiving treatment without providing the physiological benefits associated with active ultrasound therapy. The sessions will be conducted once per week over three consecutive weeks.

Intervention Type DEVICE

EEG/HRV/RSA (Electroencephalography, Heart Rate Variability, Respiratory Sinus Arrhythmia) Monitoring using Infiniti System

Participants in this study will undergo monitoring of Heart Rate Variability (HRV), and Respiratory Sinus Arrhythmia (RSA) using the Infiniti 8 measuring device. This system includes a ProComp Infiniti encoder, which is a versatile and advanced tool for capturing physiological signals, and the Biograph Infiniti software, which, along with the Physiology Suit, allows for detailed analysis and monitoring of autonomic nervous system function.

Intervention Type DEVICE

Other Intervention Names

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EEG/HRV/RSA (Electroencephalography, Respiratory Sinus Arrhythmia) Infiniti 8 measuring device, a ProComp Infiniti encoder, and Biograph Infiniti and Physiology Suit software

Eligibility Criteria

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Inclusion Criteria

* Age between 20 and 60 years.
* Subjects not currently undergoing any form of rehabilitation, physiotherapy, or osteopathy

Exclusion Criteria

* Unstable arrhythmia in the patient's history and symptoms related to chest organs (retrosternal pain, difficulty breathing).
* Pregnancy.
* Menstruation.
* Smoking.
* Symptoms suggestive of disorders related to bowel obstruction (bloating with pain, vomiting, diarrhea).
* Surgical treatment in the head.
* Neurological diseases.
* Back and peripheral joint pain, trauma, and musculoskeletal dysfunction in the last 12 months.
* Having undergone physiotherapy or osteopathy treatment within the last month, regardless of the reason

Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes