Immediate Effect of Cervical and Sacroiliac Manipulation on the Autonomic Nervous System and Balance (CSMPAANS)

October 14, 2024 updated by: SEFA HAKTAN HATIK

Comparison Of Spinal Manipulation Applied to the Cervical Spine and Sacroiliac Joints With Pedobarographic Analysis and It's Immediate Effect on the Autonomic Nervous System in Healthy Individuals

The aim of this study is to investigate the immediate effects of high-velocity low-amplitude (HVLA) chiropractic manipulation on the autonomic nervous system and baropodometric parameters. The effects of different manipulation techniques on pedobarographic analysis and the autonomic nervous system were examined.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Ninety-six individuals who met the inclusion criteria participated in the study. The participants were divided into three groups: the sacroiliac joint manipulation group (n=32), the cervical manipulation group (n=32), and the control group (n=30). No treatment was administered to the control group, while sacroiliac joint manipulation and cervical manipulation were applied to the sacroiliac joint manipulation group and the cervical manipulation group, respectively. Autonomic nervous system activity was assessed using the Polar H-10 device, pedobarographic analysis was performed using the METISENS pedobarographic evaluation device, and blood pressure and pulse were measured manually from the left arm using a sphygmomanometer. A 30-minute waiting period was used during the evaluation of the control group. A significance level of p<0.05 was considered

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
96

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Locations

  • Turkey
      • Sinop, Turkey
        • Sinop University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Willingness to participate voluntarily.
  • Signed informed consent form.
  • Age between 18 and 35 years.
  • No contraindications for chiropractic practices.

Exclusion Criteria:

  • History of orthopedic disabilities related to the lower extremity.
  • Ankylosing spondylitis, rheumatoid arthritis.
  • History of foot sprain/strain within the past six months.
  • Presence of pathologies in the lumbar and sacroiliac regions (herniated discs, spondylosis, spondylolisthesis).
  • History of cardiovascular and respiratory diseases.
  • Psychiatric disorders such as psychosis and depression.
  • Radicular root compressions causing progressive neurological deficits.
  • Bleeding/coagulation disorders and receiving anticoagulant treatment.
  • Acute fractures and orthopedic trauma.
  • Spinal cord tumors and meningeal tumors.
  • Intraosseous infections and acute inflammation, such as osteomyelitis.
  • Cauda equina syndrome.
  • Intracanicular hematomas.
  • Spinal cord hematomas in the spine.
  • Basilar invagination of the upper cervical region.
  • Aneurysmal bone cysts, osteoid osteomas, osteolastomas, giant cell bone tumors.
  • Post-surgical fixation prostheses.
  • Neoplastic diseases in muscles or other tissues.
  • Lhermitte's sign.
  • Syringomyelia.
  • Vertebral dislocations or hypermobile joints.
  • Advanced osteoporosis.
  • Vertebrobasilar insufficiency.

Criteria for Withdrawal from the Study:

  • Pregnancy or suspicion of pregnancy.
  • The volunteer's desire to discontinue participation in the study.

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: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Sacroiliac Joint Manipulation Group
Sacroiliac joint manipulation was performed on this group in the lateral decubitus position.
Other: Sacroiliac Joint Manipulation
The patient was asked to tie his arms while he was in the side lying position. The patient's upper knee was flexed and positioned such that it was placed in the popliteal fossa of the lower knee, while the lower knee was in full extension. Pushing maneuver was performed with HVLA from posterior to anterior and from medial to lateral with pelvic rotation. The contact point of the sacroiliac joint was PSIS.
Experimental: Cervical Joint Manipulation Group
Cervical joint manipulation was performed on this group in the supine position.
Other: Cervical Spine Manipulation
Cervical SM was applied supine to restrictions found on motion palpation, according to the technique described by Bergmann and Peterson28 The participant's head and neck were simultaneously rotated and laterally flexed over the contact point-specifically, the posterior supramastoid groove or zygomatic arch (C0-C1), the posterior aspect of the transverse process (C1-C2), or the posterior articular pillar of superior vertebrae (C2-C7) -to the end of passive ROM. Thereafter, a high-velocity, low-amplitude thrust was delivered in the direction of restricted movement. Participants with more ROM restriction in the lateral plane were given more lateral-to-medial directed thrusts; participants with more restriction in rotation were given thrusts in the direction of restricted axial rotation; and participants with more restriction in extension were given more anteriorly directed thrusts.
No Intervention: Control Group
This group did not undergo any interventions.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Evaluation of Autonomic Nervous System
Time Frame: In the manipulation groups, measurements were repeated immediately after the manipulation, while in the control group, the initial measurements were repeated 30 minutes later.

The assessment of the autonomic nervous system was conducted using the Polar H10 device, which is a high-accuracy, gold-standard HRV sensor that comes with a chest-worn strap. The device can connect to multiple components via Bluetooth and ANT+. This device facilitates the measurement of heart rate variability (HRV), R-R intervals, RMSSD (an instantaneous assessment of the parasympathetic system), LF Power (activation of the sympathetic nervous system), HF Power (activation of the parasympathetic nervous system), HF band, and LF/HF ratio (sympathetic-vagal balance).

For data analysis, the Elite HRV software supported by the device is utilized. Measurements are conducted while the participant is seated and last approximately one minute. To ensure accurate measurements, it is necessary to moisten the electrode surface before each measurement. During the assessment, the participant should not speak or move
In the manipulation groups, measurements were repeated immediately after the manipulation, while in the control group, the initial measurements were repeated 30 minutes later.
Evaluation of Blood Pressure
Time Frame: In the manipulation groups, measurements were repeated immediately after the manipulation, while in the control group, the initial measurements were repeated 30 minutes later.
Blood pressure of the participants were evaluated with a manual sphygmomanometer on the left arm.
In the manipulation groups, measurements were repeated immediately after the manipulation, while in the control group, the initial measurements were repeated 30 minutes later.
Analysis of Pedobarographic Data
Time Frame: In the manipulation groups, measurements were repeated immediately after the manipulation, while in the control group, the initial measurements were repeated 30 minutes later.
The analysis of pedobarographic data was conducted using METISENS pedobarographic assessment devices. During the measurements of pressure analysis in individuals participating in our study, static conditions were maintained, and the load distribution on both the right and left feet, as well as the loads on the anterior and posterior aspects of the foot (%), were reported. Pressure analyses were determined using the Metisens Baropodometric Analysis software, which is the proprietary software that operates in conjunction with the Metisens Pedobarographic Assessment Device (It is not possible to separate these measurements as the device takes all measurements and provides a total analysis.)
In the manipulation groups, measurements were repeated immediately after the manipulation, while in the control group, the initial measurements were repeated 30 minutes later.
Evaluation of Pulse
Time Frame: In the manipulation groups, measurements were repeated immediately after the manipulation, while in the control group, the initial measurements were repeated 30 minutes later.
The pulse of the participants were evaluated with a manual sphygmomanometer on the left arm.
In the manipulation groups, measurements were repeated immediately after the manipulation, while in the control group, the initial measurements were repeated 30 minutes later.

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
SEFA HAKTAN HATIK

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: SEFA H HATIK, Asst. Prof., Sinop University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 9, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 14, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 15, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 15, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 14, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CMT0006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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