- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05786118
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
Completed
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
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 Locations
-
-
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Kutahya, Turkey, 43100
- Kutahya Health Sciences University Evliya Celebi Hospital Physical Therapy and Rehabilitation Department
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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
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 |
Intervention / Treatment |
|---|---|
|
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.
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There is no intervention in this study
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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.
|
There is no intervention in this study
|
What is the study measuring?
Primary Outcome Measures
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.
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1 minutes
|
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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.
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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.
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1 minutes
|
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Center of Pressure path length of balance parameters
Time Frame: 2 minutes
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Center of Pressure path length will be evaluated using with gait platform.
The software gives the outcome as mm.
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2 minutes
|
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Ellipse area of balance parameters
Time Frame: 1 minutes
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Ellipse area will be evaluated using with gait platform.
The software gives the outcome as mm2.
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1 minutes
|
Secondary Outcome Measures
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.
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5 minutes
|
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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.
Investigators
- Principal Investigator: Ismail S [isaracoglu], P.hD., Kütahya 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)
March 21, 2023
Primary Completion (Actual)
May 30, 2023
Study Completion (Actual)
September 30, 2023
Study Registration Dates
First Submitted
March 14, 2023
First Submitted That Met QC Criteria
March 14, 2023
First Posted (Actual)
March 27, 2023
Study Record Updates
Last Update Posted (Actual)
November 29, 2023
Last Update Submitted That Met QC Criteria
November 28, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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