NCT05850910

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 30, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

May 1, 2023

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 9, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 17, 2023

Completed
Last Updated

July 18, 2023

Status Verified

July 1, 2023

Enrollment Period

Same day

First QC Date

April 30, 2023

Last Update Submit

July 17, 2023

Conditions

Vagus Nerve Autonomic Disorder

Keywords

manipulation

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (2)

Supine practice group

EXPERIMENTAL

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

Other: Supine practice group

Prone application group

EXPERIMENTAL

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

Other: Prone application group

Interventions

Supine practice groupOTHER

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.

Supine practice group
Prone application groupOTHER

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.

Prone application group

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • People who volunteered to work and signed the consent form

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HAZAL genç

Istanbul, None Selected, 34353, Turkey (Türkiye)

Location

Related 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.

    PMID: 33496535BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 30, 2023

First Posted

May 9, 2023

Study Start

May 1, 2023

Primary Completion

May 1, 2023

Study Completion

July 17, 2023

Last Updated

July 18, 2023

Record last verified: 2023-07

Locations

TU(1)