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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05786118
Other study ID # CLBP and SIJ
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 21, 2023
Est. completion date September 30, 2023

Study information

Verified date November 2023
Source Kutahya Health Sciences University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 61
Est. completion date September 30, 2023
Est. primary completion date May 30, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Intervention

Other:
No intervention
There is no intervention in this study

Locations

Country Name City State
Turkey Kutahya Health Sciences University Evliya Celebi Hospital Physical Therapy and Rehabilitation Department Kutahya

Sponsors (1)

Lead Sponsor Collaborator
Kutahya Health Sciences University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Gate speed of time-distance gait parameters Gate speed will be evaluated using with gait platform. The software gives the outcome as km/h. 1 minutes
Primary Step length of time-distance gait parameters Step lengt will be evaluated using with gait platform. The software gives the outcome as cm and calcules for each lower extremity. 1 minutes
Primary Stride length of time-distance gait parameters Stride length will be evaluated using with gait platform.The software gives the outcome as cm. 1 minutes
Primary Step time of time-distance gait parameters Step time will be evaluated using with gait platform.The software gives the outcome as sec and calcules for each lower extremity. 1 minutes
Primary Stride time of time-distance gait parameters Stride time will be evaluated using with gait platform.The software gives the outcome as sec and calcules for each lower extremity. 1 minutes
Primary Cadance of time-distance gait parameters Cadance time will be evaluated using with gait platform.The software gives the outcome as steps/min. 1 minutes
Primary Center of Pressure path length of balance parameters Center of Pressure path length will be evaluated using with gait platform. The software gives the outcome as mm. 2 minutes
Primary Ellipse area of balance parameters Ellipse area will be evaluated using with gait platform. The software gives the outcome as mm2. 1 minutes
Secondary Oswestry Disability Index 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
Secondary Numeric Pain Rating Scale 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
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