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OpenTrials
Completed

NCT Number: NCT05850910

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

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.

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Key information

Conditions

Vagus Nerve Autonomic Disorder

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

HAZAL genç

Istanbul, None Selected, 34353, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Supine practice group

Other

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

Other

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.

Primary outcomes

  1. Autonomic nervous system device

    Time frame: one day

    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.

  2. Finger Oximeter

    Time frame: one day

    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.

Sponsors and collaborators

Lead sponsor

Istanbul Medipol University Hospital

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
May 9, 2023
Registry last updated
Jul 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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