Effects of Osteopathic Technique on Autonomic Nervous System Activity

SomaticMed

Status: Enrolling

Conditions: Healthy; Dysautonomia

Treatments: Procedure: CV4 + RR; Device: EEG/HRV/RSA (Electroencephalography, Heart Rate Variability, Respiratory Sinus Arrhythmia) Monitoring using Infiniti System; Procedure: CV4; Device: Ultrasound Transducer Sham Procedure; Device: sham ultrasound transducer

Study type: Interventional

Funder types: Other

Identifiers

NCT06554834

SOMATIC2024-001

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 109 estimated patients

Sex: All

Ages: 20 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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109 participants in 3 patient groups, including a placebo group

CV4 + RR Group

Experimental group

Description:

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

Treatment:

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

Procedure: CV4 + RR

CV4 Group

Experimental group

Description:

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

Treatment:

Procedure: CV4

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

Placebo Group

Placebo Comparator group

Description:

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

Treatment:

Device: sham ultrasound transducer

Device: Ultrasound Transducer Sham Procedure

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