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

July 17, 2023 updated by: hazal genc, Istanbul Medipol University Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

62

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
    • None Selected
      • Istanbul, None Selected, Turkey, 34353

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Supine practice group
The participant was asked to cross his arms in front of his body while lying on his back.
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.
Experimental: Prone application group
The participant positions their hands freely from the side of the treatment table in the prone position.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
one day
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.
one day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul Medipol University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2023

Primary Completion (Actual)

May 1, 2023

Study Completion (Actual)

July 17, 2023

Study Registration Dates

First Submitted

April 30, 2023

First Submitted That Met QC Criteria

April 30, 2023

First Posted (Actual)

May 9, 2023

Study Record Updates

Last Update Posted (Actual)

July 18, 2023

Last Update Submitted That Met QC Criteria

July 17, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Approval Number: 19.01.2023-29

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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