Effects of Osteopathic Technique on Autonomic Nervous System Activity

Official title

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

Overview

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).

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.

Interventions

• 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 fu
• 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 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 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 thr
• 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.

Primary outcome measures

• Heart Rate Variability (HRV) [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).]
• High-Frequency Power (HF) [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).]
• Low-Frequency Power (LF [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).]
• LF/HF Ratio [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).]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Poland · 1 center

• SomaticMed — Wołomin

Identifiers

NCT: NCT06554834 · SOMATIC2024-001

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗