Clinical trial NCT06554834: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy
Dysautonomia
Keywords: Autonomic Nervous System
Osteopathic Medicine
Heart Rate Variability
Lead sponsor: SomaticMed
Sponsor class: OTHER
First posted: 2024-08-15
Enrollment: 109
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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).

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.

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

Primary outcomes:
measure: Heart Rate Variability (HRV)
timeFrame: 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).
measure: High-Frequency Power (HF)
timeFrame: 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).
measure: Low-Frequency Power (LF
timeFrame: 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).
measure: LF/HF Ratio
timeFrame: 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).
Secondary outcomes:
Other outcomes:
Locations:
city: Wołomin
country: Poland
facility: SomaticMed
state: Prądzyńskiego
Study officials:
References: