Effects of Osteopathic Technique on Autonomic Nervous System Activity
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-65
SponsorSomaticMed
About this trial
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).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age between 20 and 60 years.
Subjects not currently undergoing any form of rehabilitation, physiotherapy, or osteopathy
Disqualifiers
Unstable arrhythmia in the patient's history and symptoms related to chest organs (retrosternal pain, difficulty breathing).
Pregnancy.
Menstruation.
Smoking.
Trial design
Design model
Parallel
Treatments tested in this trial
CV4 + RR
Procedure/SurgeryParticipants 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
Procedure/SurgeryParticipants 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.
sham ultrasound transducer
DeviceParticipants 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
DeviceParticipants 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
DeviceParticipants 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.
Treatment groups
109 Participants
are divided into 3 treatment groupsGroup A: CV4 + RR GroupExperimental treatment 2 interventions
Group B: CV4 GroupExperimental treatment 2 interventions
Group C: Placebo GroupPlacebo comparator 3 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
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).2
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.
Time frame
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).3
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.
Time frame
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).4
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.
Time frame
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). Source ClinicalTrials.gov