Back to resultsComparison Of The Immediate Effects Of Manipulation On The Autonomic Nervous System
Primary Purpose
Vagus Nerve Autonomic Disorder
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Supine practice group
Prone application group
Sponsored by
About this trial
This is an interventional treatment trial for Vagus Nerve Autonomic Disorder focused on measuring manipulation
Eligibility Criteria
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)
Sites / Locations
- HAZAL genç
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Supine practice group
Prone application group
Arm Description
The participant was asked to cross his arms in front of his body while lying on his back.
The participant positions their hands freely from the side of the treatment table in the prone position.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05850910
First Posted
April 30, 2023
Last Updated
July 17, 2023
Sponsor
Istanbul Medipol University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05850910
Brief Title
Comparison Of The Immediate Effects Of Manipulation On The Autonomic Nervous System
Official Title
Comparison Of The Immediate Effects Of Manipulation On The Autonomic Nervous System
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
May 1, 2023 (Actual)
Primary Completion Date
May 1, 2023 (Actual)
Study Completion Date
July 17, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Medipol University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vagus Nerve Autonomic Disorder
Keywords
manipulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Supine practice group
Arm Type
Experimental
Arm Description
The participant was asked to cross his arms in front of his body while lying on his back.
Arm Title
Prone application group
Arm Type
Experimental
Arm Description
The participant positions their hands freely from the side of the treatment table in the prone position.
Intervention Type
Other
Intervention Name(s)
Supine practice group
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Prone application group
Intervention Description
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 Outcome Measure Information:
Title
Autonomic nervous system device
Description
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.
Time Frame
one day
Title
Finger Oximeter
Description
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.
Time Frame
one day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Facility Information:
Facility Name
HAZAL genç
City
Istanbul
State/Province
None Selected
ZIP/Postal Code
34353
Country
Turkey
12. IPD Sharing Statement
Citations:
PubMed Identifier
33496535
Citation
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.
Results Reference
background
Learn more about this trial
Comparison Of The Immediate Effects Of Manipulation On The Autonomic Nervous System
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