Effects of Osteopathic Technique on Autonomic Nervous System Activity

NCT06554834 | Recruiting

• 1 other identifier: SOMATIC2024-001
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Healthy; Dysautonomia

Keywords

Autonomic Nervous System; Osteopathic Medicine; Heart Rate Variability

Outcome Measures

Primary Outcomes (4)

• 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).

Study Arms (3)

CV4 + RR Group

EXPERIMENTAL

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

Procedure: CV4 + RR; Device: EEG/HRV/RSA (Electroencephalography, Heart Rate Variability, Respiratory Sinus Arrhythmia) Monitoring using Infiniti System

CV4 Group

EXPERIMENTAL

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

Procedure: CV4; Device: EEG/HRV/RSA (Electroencephalography, Heart Rate Variability, Respiratory Sinus Arrhythmia) Monitoring using Infiniti System

Placebo Group

PLACEBO COMPARATOR

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

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

Interventions

CV4 + RR 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.

CV4 + RR Group

CV4 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.

CV4 Group

sham ultrasound transducer 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.

Placebo Group

Ultrasound Transducer Sham Procedure 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.

Placebo Group

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

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

CV4 + RR Group; CV4 Group; Placebo Group

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• SomaticMed: lead

Study Sites (1)

SomaticMed

Wołomin, Prądzyńskiego, 05-200, Poland

RECRUITING

MeSH Terms

Conditions

Autonomic Nervous System Diseases

Interventions

Electroencephalography

Condition Hierarchy (Ancestors)

Nervous System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Neurological; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Central Study Contacts

Jakub H Stępnik, MSc, D.O.

CONTACT

535706466; j.s.rehabilitacja@op.pl

Agnieszka Kędra, Prof. Ph.D.

CONTACT

600951350; agnieszka.kedra@awf.edu.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 12, 2024
• First Posted: August 15, 2024
• Study Start: June 20, 2024
• Primary Completion: October 20, 2024
• Study Completion: November 10, 2024
• Last Updated: August 16, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)