The Immediate Effect of Sacroiliac Joint Manipulation in Standing Workers (IESJMSW)

September 17, 2024 updated by: SEFA HAKTAN HATIK

The Immediate Effect of Sacroiliac Joint Manipulation on Postural Balance, Range of Motion and Muscle Strength in Standing Workers

The aim of this study was to determine whether sacroiliac joint manipulation has a positive effect on muscle strength, balance and range of motion in standing workers.

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

The study included 40 participants who were previously informed about the study, met the inclusion criteria and signed the consent form. Participants were randomly divided into two groups as sacroiliac joint manipulation group (n=20) and control group (n=20). Hip and lumbar range of motion was assessed with a goniometer, postural control and balance with Biodex, and quadriceps femoris and hamstring muscle strength with MicroFet®2. The sacroiliac joint manipulation group underwent sacroiliac joint manipulation and the control group did not undergo any procedure. The effect of the manipulation was measured immediately after the manipulation and the significance level was accepted as p<0,05.

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.
40

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

No

Description

Inclusion Criteria:

  • Having signed the voluntary consent form
  • Being between the ages of 18-50
  • Working standing for at least 3 hours a day
  • Working standing for at least 6 months
  • Suffering from low back pain in the last 6 months.

Exclusion Criteria:

  • Having diseases that may cause balance problems
  • Having a history of trauma in the last 6 months
  • Pregnancy or suspicion of pregnancy
  • Contraindications to chiropractic treatment (such as tumor, rheumatological condition, fracture, dislocation, metastasis and aneurysm)
  • Feeling pain in the pelvis and sacroiliac joint,

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 in lateral decubitis position.
Other: Sacroiliac Joint Manipulation
Sacroiliac manipulation was performed using manual treatment method by lying patients on their sides. First, the patient was positioned firmly on the edge of the examination table, while the restricted sacroiliac joint remains on the upper side. Then, the physician's hand was positioned on the patient's hip, and the flexion was made on the lumbar spine with the movement from the hip to the upper thigh, and the impulse given by the HVLA technique was applied in the anteroinferior direction to the iliac crest and trochanter major.
No Intervention: Control Group
The control group did not undergo any treatment.

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
Biodex Balance System
Time Frame: It was performed immediately after the manipulation. In the control group, the first measurement was performed and the second measurement was repeated after waiting for 15 minutes.
Biodex Balance System (Biodex, Inc, Shirley, New York) (BDS) device was used to measure postural balance. It can extract anterior-posterior stability index (APSI), mediolateral stability index (MLSI) and overall stability index (OSI) for the measurement of standing posture control. Lower oscillation scores indicate better postural stability (Sung and Kim, 2018). The bipedal balance tests were performed with eyes open and closed and the volunteers were measured with their hands at their sides. The tests were performed for 30 seconds.
It was performed immediately after the manipulation. In the control group, the first measurement was performed and the second measurement was repeated after waiting for 15 minutes.
Muscle Strength
Time Frame: It was performed immediately after the manipulation. In the control group, the first measurement was performed and the second measurement was repeated after waiting for 15 minutes.
Muscle strength measurements were performed with microFET ®2, a digital handheld dynamometer. The measurement is based on the compression principle and has high reliability and measurement accuracy. The results were recorded in kilograms of force (kgf) and measurements were taken from the quadriceps femoris and hamstring muscles.
It was performed immediately after the manipulation. In the control group, the first measurement was performed and the second measurement was repeated after waiting for 15 minutes.
Range of Motion
Time Frame: It was performed immediately after the manipulation. In the control group, the first measurement was performed and the second measurement was repeated after waiting for 15 minutes.
Range of motion (ROM) measurements were performed with a universal goniometer. Degree was used as the unit of measurement. Flexion, extension, internal rotation, external rotation, abduction and adduction angles were measured bilaterally for the hip joint. Flexion, extension and lateral flexion (left-right) were measured in the lumbar region. For these values, the values determined by the American Association of Orthopedic Surgeons were taken as a basis, recorded during the measurement and proceeded in order.
It was performed immediately after the manipulation. In the control group, the first measurement was performed and the second measurement was repeated after waiting for 15 minutes.

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

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.
July 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.
August 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.
September 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).
September 17, 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.
September 17, 2024

First Posted (Estimated)

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.
September 19, 2024

Study Record Updates

Last Update Posted (Estimated)

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.
September 19, 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.
September 17, 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.
July 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.
  • CMT0005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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