Effects of Osteopathic Technique on Autonomic Nervous System Activity (Osteo)

Effects of Three Therapeutic Sessions of the Fourth Ventricle Compression Technique and Rib Raising Osteopathic Technique on Autonomic Nervous System Activity Measured by Heart Rate Variability in 109 Healthy Individuals

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).

Study Overview

• Status: Recruiting
• Conditions: Healthy; Dysautonomia
• Intervention / Treatment: Procedure: CV4 + RR; Procedure: CV4; Device: sham ultrasound transducer; Device: EEG/HRV/RSA (Electroencephalography, Heart Rate Variability, Respiratory Sinus Arrhythmia) Monitoring using Infiniti System; Device: Ultrasound Transducer Sham Procedure

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 109
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jakub H Stępnik, MSc, D.O.; Phone Number: 535706466; Email: j.s.rehabilitacja@op.pl
• Study Contact Backup: Name: Agnieszka Kędra, Prof. Ph.D.; Phone Number: 600951350; Email: agnieszka.kedra@awf.edu.pl

Study Locations

• Poland
  • Prądzyńskiego
    • Wołomin, Prądzyńskiego, Poland, 05-200
      • Recruiting
      • SomaticMed
      • Contact: Jakub H Stępnik, MSc, D.O.; Phone Number: 792012697; Email: j.s.rehabilitacja@op.pl
      • Contact: Email: j.s.rehabilitacja@op.pl
      • Principal Investigator: Jakub H Stępnik, MSc, Do.O.
      • Sub-Investigator: Agnieszka Kędra, Prof., PhD
      • Sub-Investigator: Dariusz Czaprowski, Prof., PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CV4 + RR Group; Participants will undergo three 30-minute sessions of osteopathic therapy combining the Fourth Ventricle Compression (CV4) and Rib Raising (RR) techniques.	Procedure: 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.; 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.; Other Names: EEG/HRV/RSA (Electroencephalography, Respiratory Sinus Arrhythmia) Infiniti 8 measuring device, a ProComp Infiniti encoder, and Biograph Infiniti and Physiology Suit software
Experimental: CV4 Group; Participants will receive three 30-minute sessions of osteopathic therapy focusing solely on the Fourth Ventricle Compression (CV4) technique.	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.; 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.; Other Names: EEG/HRV/RSA (Electroencephalography, Respiratory Sinus Arrhythmia) Infiniti 8 measuring device, a ProComp Infiniti encoder, and Biograph Infiniti and Physiology Suit software
Placebo Comparator: Placebo Group; Participants will undergo a sham procedure involving an ultrasound transducer for three 30-minute sessions, with no therapeutic intervention.	Device: 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.; 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.; Other Names: EEG/HRV/RSA (Electroencephalography, Respiratory Sinus Arrhythmia) Infiniti 8 measuring device, a ProComp Infiniti encoder, and Biograph Infiniti and Physiology Suit software; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart Rate Variability (HRV)	Changes in Heart Rate Variability will be assessed to evaluate the overall autonomic nervous system (ANS) function. HRV will be measured using the standard deviation of normal-to-normal intervals (SDNN) and other relevant time-domain and frequency-domain parameters. Measurements will be taken before the intervention, immediately after the third session, and one month after the final session to evaluate both immediate and sustained effects.	Measurements will be taken at three time points: before the intervention (baseline), immediately after the third session (post-intervention), and one month after the final session (follow-up).
High-Frequency Power (HF)	The HF component of HRV, which reflects parasympathetic (vagal) activity, will be measured. Changes in HF power will indicate the impact of the osteopathic techniques on parasympathetic regulation. HF power will be expressed in absolute units (ms²) and as a normalized unit.	Measurements will be taken at three time points: before the intervention (baseline), immediately after the third session (post-intervention), and one month after the final session (follow-up).
Low-Frequency Power (LF	The LF component of HRV, associated with both sympathetic and parasympathetic activity, will be assessed. LF power will be measured to understand its modulation through the interventions. LF power will be reported in absolute units (ms²) and as a normalized unit.	Measurements will be taken at three time points: before the intervention (baseline), immediately after the third session (post-intervention), and one month after the final session (follow-up).
LF/HF Ratio	The ratio of LF to HF power (LF/HF) will be analyzed as an indicator of the balance between sympathetic and parasympathetic nervous system activity. This measure will help determine the relative predominance of each branch of the autonomic nervous system in response to the osteopathic interventions.	Measurements will be taken at three time points: before the intervention (baseline), immediately after the third session (post-intervention), and one month after the final session (follow-up).

Collaborators and Investigators

• Sponsor: SomaticMed

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2024
• Primary Completion (Estimated): October 20, 2024
• Study Completion (Estimated): November 10, 2024

Study Registration Dates

• First Submitted: August 12, 2024
• First Submitted That Met QC Criteria: August 14, 2024
• First Posted (Actual): August 15, 2024

Study Record Updates

• Last Update Posted (Actual): August 16, 2024
• Last Update Submitted That Met QC Criteria: August 14, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Autonomic Nervous System; Heart Rate Variability; Osteopathic Medicine
• Additional Relevant MeSH Terms: Nervous System Diseases; Primary Dysautonomias; Autonomic Nervous System Diseases
• Other Study ID Numbers: SOMATIC2024-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual Participant Data (IPD) will not be shared due to concerns regarding the protection of participant privacy and legal restrictions related to the processing of personal data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No