Low Back PainNCT05095402
Biomechanics of Lumbar Region in Low Back Pain
An observational study of Low Back Pain, run by Karabuk University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study was to examine the relationship between non-specific low back pain (NSLBP) and lumbar lordosis angle (LLA) and lumbar muscle thickness (LMT) by evaluating magnetic resonance images (MRI) in individuals with LBP. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Low Back Pain
- How many people
- 96 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Apr 2019to 25 Sep 2020
- How long will I take part?
- 1 Day
- 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: The study included a total of 96 individuals, 43 males, and 53 females, who applied to the Department of Radiology of the Karabuk University Training and Research Hospital between March-June 2019 with complaints of LBP.
Who may be able to join
- The age range of 18-65
- Having non-specific LBP
- Volunteering to participate in the study
Who cannot join
- Having any psychiatric and mental problems
- The presence of any disc, bone, and muscular pathology in the lumbar region
- Having any previous operation on the lumbar region
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Relationship Between Lumbar Lordosis Angle and Lumbar Muscle Thickness With Non-Specific Low Back Pain
The purpose of this study was to examine the relationship between non-specific low back pain (NSLBP) and lumbar lordosis angle (LLA) and lumbar muscle thickness (LMT) by evaluating magnetic resonance images (MRI) in individuals with LBP.
Read the detailed description
The study included a total of 96 individuals, 43 males, and 53 females, who applied to the Department of Radiology of the Karabuk University Training and Research Hospital between March-June 2019 with complaints of LBP. Individuals' sociodemographic information and medical history were recorded using the LBP assessment form. The Oswestry LBP Disability Questionnaire was used for LBP. Thickness measurements of muscle (m.) psoas major, m. multifidus, m. quadratus lumborum and m. erector spinae were taken on MRI corresponding to the L3-L4 vertebra level. Cobb Angle method was used for LLA determination. Measurements were made in three repetitions using the Radiant DICOM viewer program, and their averages were recorded.
- Conditions
- Low Back Pain
- Keywords
- Low Back Pain, Lumbar Lordosis Angle, Magnetic Resonance Imaging, Muscle Thickness
- Medical subject headings
- Low Back Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
Disability caused by low back pain assessed by Oswestry Low Back Pain Disability Questionnaire
Low back pain disability is assessed with Oswestry Low Back Pain Disability Questionnaire.
Oswestry Disability Index (ODI) score as a percentage is obtained from the questionnaire result.
Measured: 6 months
Lumbar lordosis angle
- Measured with the COBB angle method as LLA degree.
- It is determined by looking at the angle between the vertebrae forming the lumbar lordosis curvature (L1-L5).
- All radiological measurements are performed on the RAdiant DICOM viewer program.
Measured: 6 months
Muscles thickness measurements
- Measured on the horizontal plane corresponding to the L3-L4 level in the sagittal plane.
- Bilaterally, the thickest parts of the muscles are measured anterior-posterior and transverse and recorded in millimetres (mm).
- All radiological measurements are performed on the RAdiant DICOM viewer program.
- Muscles measured are listed below:
- m. psoas major
- m. multifidus
- m. erector spinae muscles
- m. quadratus lumborum
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2021
- Study start19 Apr 2019
- Primary completion30 Jun 2019
- Study completion25 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 96 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Karabuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Cihan Dagli, Karabuk University
- Investigators
- Ali dagli, Principal investigator, Karabuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05095402
- Sponsor's protocol ID
- KU-ANA-ACD-01
- Status last verified
- Oct 2021
- First submitted
- 14 Sep 2021
- Last updated
- 27 Oct 2021
- 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 27 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Relationship Between Lumbar Lordosis Angle and Lumbar Muscle Thickness With Non-Specific Low Back Pain
- ClinicalTrials.gov ID
- NCT05095402
- Acronym / sponsor ID
- KU-ANA-ACD-01
- Conditions
- Low Back Pain
- Keywords
- Low Back Pain, Lumbar Lordosis Angle, Magnetic Resonance Imaging, Muscle Thickness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Karabuk UniversityUniversity, hospital or other
- Study start
- 19 Apr 2019 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 25 Sep 2020 (actual)
- First posted
- 27 Oct 2021 (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.
The purpose of this study was to examine the relationship between non-specific low back pain (NSLBP) and lumbar lordosis angle (LLA) and lumbar muscle thickness (LMT) by evaluating magnetic resonance images (MRI) in individuals with LBP.
Detailed description
The study included a total of 96 individuals, 43 males, and 53 females, who applied to the Department of Radiology of the Karabuk University Training and Research Hospital between March-June 2019 with complaints of LBP. Individuals' sociodemographic information and medical history were recorded using the LBP assessment form. The Oswestry LBP Disability Questionnaire was used for LBP. Thickness measurements of muscle (m.) psoas major, m. multifidus, m. quadratus lumborum and m. erector spinae were taken on MRI corresponding to the L3-L4 vertebra level. Cobb Angle method was used for LLA determination. Measurements were made in three repetitions using the Radiant DICOM viewer program, and their averages were recorded.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study included a total of 96 individuals, 43 males, and 53 females, who applied to the Department of Radiology of the Karabuk University Training and Research Hospital between March-June 2019 with complaints of LBP.
Key inclusion criteria (3 listed)
- The age range of 18-65
- Having non-specific LBP
- Volunteering to participate in the study
Key exclusion criteria (3 listed)
- Having any psychiatric and mental problems
- The presence of any disc, bone, and muscular pathology in the lumbar region
- Having any previous operation on the lumbar region
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Disability caused by low back pain assessed by Oswestry Low Back Pain Disability Questionnaire
Time frame: 6 months
Low back pain disability is assessed with Oswestry Low Back Pain Disability Questionnaire. Oswestry Disability Index (ODI) score as a percentage is obtained from the questionnaire result.
Lumbar lordosis angle
Time frame: 6 months
* Measured with the COBB angle method as LLA degree. * It is determined by looking at the angle between the vertebrae forming the lumbar lordosis curvature (L1-L5). * All radiological measurements are performed on the RAdiant DICOM viewer program.
Muscles thickness measurements
Time frame: 6 months
* Measured on the horizontal plane corresponding to the L3-L4 level in the sagittal plane. * Bilaterally, the thickest parts of the muscles are measured anterior-posterior and transverse and recorded in millimetres (mm). * All radiological measurements are performed on the RAdiant DICOM viewer program. * Muscles measured are listed below: * m. psoas major * m. multifidus * m. erector spinae muscles * m. quadratus lumborum
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 27 Oct 2021.
- 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.
Ali dagli principal investigator
Karabuk 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 Low Back Pain, run by Karabuk 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 3 inclusion and 3 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 27 Oct 2021. 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?
Disability caused by low back pain assessed by Oswestry Low Back Pain Disability Questionnaire (time frame: 6 months). The study lists 3 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 27 Oct 2021.