The Effects of Sacroiliac Joint Dysfunction on Gait and Disability

November 28, 2023 updated by: Ismail Saracoglu, Kutahya Health Sciences University

The Effects of Sacroiliac Joint Dysfunction on Gait and Disability in Patients With Chronic

It has been reported that gait coordination changes in patients with chronic low back pain, walking slower, taking shorter steps and having asymmetrical stride lengths compared to their healthy peers. In addition to many factor cause gait dysfunction, sacroiliac joint dysfunction might be one of reason of these problems. A study examining the effects of sacroiliac joint dysfunction on gait and disability in individuals with chronic low back pain has not been found in the literature. Therefore, the aim of this study is to evaluate the gait parameters and disability of individuals with chronic low back pain and to reveal their relationship with sacroiliac joint dysfunction.

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.

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.
Observational

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.
61

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey
      • Kutahya, Turkey, 43100
        • Kutahya Health Sciences University Evliya Celebi Hospital Physical Therapy and Rehabilitation Department

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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Participants who directly presented to the Physical Therapy Department of Kutahya Health Sciences University Hospital during the study period with persistent low back pain, will be screened for eligibility by an independent physician (H.H.G.)

Description

Inclusion Criteria:

  • Volunteered to participate in the study.
  • Patients with 18-65 years
  • Low back pain for at least 3 months,
  • Reported pain severity of 2 or greater according to the numeric pain rating scale

Exclusion Criteria:

  • Previous spine or lower extremity surgery
  • Pregnancy
  • Severe hypermobility syndromes
  • Severe osteoporosis
  • Spondyloarthropathies
  • Spondylolisthesis
  • Systemic inflammatory diseases
  • Any neurological disorder that affects balance and gait

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.
SIJ Group
Individuals with sacroiliac joint dysfunction: Participants will be grouped as positive sacroiliac joint dysfunction according to Laslett's algorithm using provocation tests to detect sacroiliac joint dysfunction.
Other: No intervention
There is no intervention in this study
Control Group
Individuals with no sacroiliac joint dysfunction: Individuals with sacroiliac joint dysfunction: Participants will be grouped as negative sacroiliac joint dysfunction according to Laslett's algorithm using provocation tests to detect sacroiliac joint dysfunction.
Other: No intervention
There is no intervention in this study

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
Gate speed of time-distance gait parameters
Time Frame: 1 minutes
Gate speed will be evaluated using with gait platform. The software gives the outcome as km/h.
1 minutes
Step length of time-distance gait parameters
Time Frame: 1 minutes
Step lengt will be evaluated using with gait platform. The software gives the outcome as cm and calcules for each lower extremity.
1 minutes
Stride length of time-distance gait parameters
Time Frame: 1 minutes
Stride length will be evaluated using with gait platform.The software gives the outcome as cm.
1 minutes
Step time of time-distance gait parameters
Time Frame: 1 minutes
Step time will be evaluated using with gait platform.The software gives the outcome as sec and calcules for each lower extremity.
1 minutes
Stride time of time-distance gait parameters
Time Frame: 1 minutes
Stride time will be evaluated using with gait platform.The software gives the outcome as sec and calcules for each lower extremity.
1 minutes
Cadance of time-distance gait parameters
Time Frame: 1 minutes
Cadance time will be evaluated using with gait platform.The software gives the outcome as steps/min.
1 minutes
Center of Pressure path length of balance parameters
Time Frame: 2 minutes
Center of Pressure path length will be evaluated using with gait platform. The software gives the outcome as mm.
2 minutes
Ellipse area of balance parameters
Time Frame: 1 minutes
Ellipse area will be evaluated using with gait platform. The software gives the outcome as mm2.
1 minutes

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Oswestry Disability Index
Time Frame: 5 minutes
The Oswestry Disability Index (ODI) is an index derived from the Oswestry Low Back Pain Questionnaire used by clinicians and researchers to quantify disability for low back pain. The self-completed questionnaire contains ten questions. Each question is scored on a scale of 0-5. The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible.
5 minutes
Numeric Pain Rating Scale
Time Frame: 1 minutes
The Numeric Pain Rating Scale (NPRS) that is a unidimensional measure of pain intensity in adults. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable".
1 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.
Kutahya Health Sciences University

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: Ismail S [isaracoglu], P.hD., Kutahya Health Sciences 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.
March 21, 2023

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.
May 30, 2023

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 30, 2023

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).
March 14, 2023

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.
March 14, 2023

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.
March 27, 2023

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.
November 29, 2023

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.
November 28, 2023

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.
November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

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.
  • CLBP and SIJ

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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