Chronic Low-back PainNCT05786118
The Effects of Sacroiliac Joint Dysfunction on Gait and Disability
An observational study of Chronic Low-back Pain and Sacroiliac Joint Dysfunction, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Low-back Pain, Sacroiliac Joint Dysfunction, Gait, Unsteady
- How many people
- 61 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Mar 2023to 30 Sep 2023
- How long will I take part?
- 2 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.)
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kutahya Health Sciences University Evliya Celebi Hospital Physical Therapy and Rehabilitation Department
Kütahya, 43100
About this study
Official title: 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.
- Being tested
- No intervention
- Medical subject headings
- Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
There is no intervention in this study
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: No intervention | |
| 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. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gate speed of time-distance gait parameters
Gate speed will be evaluated using with gait platform. The software gives the outcome as km/h.
Measured: 1 minutes
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.
Measured: 1 minutes
Stride length of time-distance gait parameters
Stride length will be evaluated using with gait platform.The software gives the outcome as cm.
Measured: 1 minutes
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.
Measured: 1 minutes
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.
Measured: 1 minutes
Cadance of time-distance gait parameters
Cadance time will be evaluated using with gait platform.The software gives the outcome as steps/min.
Measured: 1 minutes
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.
Measured: 2 minutes
Ellipse area of balance parameters
Ellipse area will be evaluated using with gait platform. The software gives the outcome as mm2.
Measured: 1 minutes
Secondary outcomes (2)
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.
Measured: 5 minutes
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".
Measured: 1 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2023
- Study start21 Mar 2023
- Primary completion30 May 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low-back PainStudies of the same condition, open and under way.
- More trials run by Kutahya Health Sciences UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 61 participants (actual)
- Target duration
- 2 Months
Sponsor and investigators
- Lead sponsor
- Kutahya Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ismail Saracoglu, Kutahya Health Sciences University
- Investigators
- Ismail S [isaracoglu], P.hD., Principal investigator, Kutahya Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05786118
- Sponsor's protocol ID
- CLBP and SIJ
- Status last verified
- Nov 2023
- First submitted
- 14 Mar 2023
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Sacroiliac Joint Dysfunction on Gait and Disability in Patients With Chronic
- ClinicalTrials.gov ID
- NCT05786118
- Acronym / sponsor ID
- CLBP and SIJ
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Study start
- 21 Mar 2023 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 27 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SIJ Group | – | Other: No interventionIndividuals 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. |
| Control Group | – | Other: No interventionIndividuals 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.)
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- Previous spine or lower extremity surgery
- Pregnancy
- Severe hypermobility syndromes
- Severe osteoporosis
- Spondyloarthropathies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionThere is no intervention in this study | Other | Control Group, SIJ Group |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
2 secondary outcomes
Oswestry Disability Index
Time frame: 5 minutes
Numeric Pain Rating Scale
Time frame: 1 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ismail S [isaracoglu], P.hD. principal investigator
Kutahya Health Sciences University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Low-back Pain and Sacroiliac Joint Dysfunction, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gate speed of time-distance gait parameters (time frame: 1 minutes). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2023.