Comparison Of The Immediate Effects Of Manipulation On The Autonomic Nervous System

Vagus Nerve Autonomic Disorder Clinical Trial

Official title:

Comparison Of The Immediate Effects Of Manipulation On The Autonomic Nervous System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05850910
• Other study ID #: Approval Number: 19.01.2023-29
• Status: Completed
• Phase: N/A
• Start date: May 1, 2023
• Est. completion date: July 17, 2023

Study information

• Verified date: July 2023
• Source: Istanbul Medipol University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

High velocity low amplitude thrust applied at the vertebral level during spinal manipulation is thought to slide the vertebrae over each other and alter segmental biomechanics.

Description:

Evidence suggests that spinal HVLA techniques may produce acute changes in skin sympathetic nerve activity. There are studies reporting that thoracic HVLA manipulation causes a statistically significant increase in cardiac vagal activity in the immediate post-intervention period compared to sham administration.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: July 17, 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion criteria:

• People who volunteered to work and signed the consent form
• Not having any of the application contraindications or exclusion criteria.
• Being between the ages of 18-45

Exclusion criteria:

• Presence of tumor, infection, trauma, inflammation
• Neurological problems (Acute myelopathy, spinal cord compression, cauda equina syndrome, nerve root compression)
• Vascular disorders (Vertebrobasilar insufficiency or cervical artery abnormalities, aortic aneurysm, angina pectoris, acute abdominal pain with preservation)

Related Conditions & MeSH terms

• Autonomic Nervous System Diseases
• Primary Dysautonomias
• Vagus Nerve Autonomic Disorder

Intervention

Other:
• Supine practice group
The practitioner's arm was placed in the mid-thoracic region from the opposite side of the individual's torso in the form of a half fist. In this position, the SPs coincide with the space in the middle of the half fist, while the TPs coincide with the fingertips and the thenar region. With the practitioner's other hand supporting the patient's elbows, a high-speed-low-amplitude thrust is applied from front to back.
• Prone application group
the practitioner positions the hypothenar part of his hands above the TPs in the mid-thoracic segment. From this point, a high-velocity-low-amplitude thrust is applied from the back to the front.

Locations

Country	Name	City	State
Turkey	HAZAL genç	Istanbul	None Selected

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Medipol University Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Rodrigues PTV, Correa LA, Reis FJJ, Meziat-Filho NA, Silva BM, Nogueira LAC. One Session of Spinal Manipulation Improves the Cardiac Autonomic Control in Patients with Musculoskeletal Pain: A Randomized Placebo-Controlled Trial. Spine (Phila Pa 1976). 2021 Jul 15;46(14):915-922. doi: 10.1097/BRS.0000000000003962. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Autonomic nervous system device	The Polar H10 device is a heart rate sensor that comes with a wearable chest strap and is the gold standard of high sensitivity and accuracy. It can be connected to multiple training devices via Bluetooth and ANT+. The device comes with a soft, adjustable sensor that touches the chest to capture the heart rate in real time.; In the study, the autonomic nervous system will be evaluated with the Polar H10 device. By connecting the device to a smart phone via bluetooth, the data will be recorded and the software supported by the device will be used for the analysis of the data.	one day
Primary	Finger Oximeter	Finger oximeter (finger pulse oximeter) measures heart rate per minute and oxygen level in blood easily and quickly.; This device, which is placed on the fingertip, measures the oxygen saturation by sensing the color tone changes in the blood depending on the oxygen with infrared rays. Oxygen saturation refers to the oxygen saturation in the blood. Typical oxygen saturation levels in a healthy person range from 95-100%. In people with lung problems, these values may be slightly lower.	one day