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

NCT ID: NCT05850910

Last Updated: 2023-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-01

Study Completion Date

2023-07-17

Brief Summary

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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

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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.

Conditions

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Vagus Nerve Autonomic Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Supine practice group

The participant was asked to cross his arms in front of his body while lying on his back.

Group Type EXPERIMENTAL

Supine practice group

Intervention Type 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

The participant positions their hands freely from the side of the treatment table in the prone position.

Group Type EXPERIMENTAL

Prone application group

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* People who volunteered to work and signed the consent form

Exclusion Criteria

* Being between the ages of 18-45


* 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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Istanbul Medipol University Hospital

OTHER

Sponsor Role lead

Responsible Party

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hazal genc

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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HAZAL genç

Istanbul, None Selected, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 33496535 (View on PubMed)

Other Identifiers

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Approval Number: 19.01.2023-29

Identifier Type: -

Identifier Source: org_study_id

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