Chronic Low Back PainNCT07860697
Association of Subcutaneous Fat Index, Paraspinal Muscle Characteristics, and Facet Morphology With Lumbar Facet Joint Degeneration
An observational study of Chronic Low Back Pain and Lumbar Facet Joint Degeneration, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
This prospective observational study aims to investigate the association between subcutaneous fat index, paraspinal muscle characteristics, facet morphology, and lumbar facet joint degeneration in adults with chronic low back pain. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Low Back Pain, Lumbar Facet Joint Degeneration
- What is being tested?
- Lumbar Magnetic Resonance Imaging (MRI)
- Type of treatment
- Injection or infusion
- How many people
- 300 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2026to 1 Jun 2027
- Phase
- Observational
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults aged 18-75 years with chronic low back pain lasting at least 3 months who present to the Algology outpatient clinic of Marmara University Faculty of Medicine Pendik Training and Research Hospital and have a lumbar MRI clinically indicated as part of routine patient management independently of the study. Routine lumbar MRI images and demographic and clinical characteristics will be evaluated for associations between subcutaneous fat index, intervertebral disc degeneration, facet joint degeneration, facet morphology, and paraspinal muscle characteristics.
Who may be able to join
- -
- Age 18-75 years.
- Low back pain lasting for at least 3 months.
- Evaluation at the Algology outpatient clinic.
- Lumbar MRI has been clinically indicated as part of routine patient management independently of the study.
- Lumbar MRI images including sagittal T1-weighted, sagittal T2-weighted, and axial T2-weighted images covering the L1-L2 through L5-S1 levels.
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- Height and body weight can be measured.
- Low back pain severity can be assessed using the Numeric Rating Scale (NRS).
- Sufficient cognitive and linguistic capacity to complete the Oswestry Disability Index.
- Ability to understand the study and provide informed consent.
- Written informed consent to participate in the study.
Who cannot join
- Previous lumbar spine surgery or lumbar fusion.
- Acute vertebral fracture or significant lumbar trauma.
- Spinal malignancy or vertebral metastasis.
- Spondylodiscitis or other spinal infections.
- Inflammatory spondyloarthritis.
- Advanced lumbar scoliosis.
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- Severe congenital lumbar vertebral anomaly.
- Anatomic variation preventing reliable identification of vertebral levels.
- Pregnancy.
- Inability to complete the MRI examination.
- MRI images inadequate for assessment of subcutaneous fat, intervertebral discs, facet joints, or paraspinal muscles.
- Missing clinical data or required outcome measures.
- Failure to provide written informed consent.
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Marmara University Pendik Training and Research Hospital
Istanbul, Istanbul, 34890
Serhat Köse, 05350150460, serhatkose03@gmail.com
Osman Hakan Gündüz, Prof.Dr.
About this study
Official title: Subkutan Yağ İndeksi, Paraspinal Kas Özellikleri ve Faset Morfolojisinin Lomber Faset Eklem Dejenerasyonu Ile İlişkisi: Disk Dejenerasyonunun Olası Aracılık Rolü
This prospective observational study aims to investigate the association between subcutaneous fat index, paraspinal muscle characteristics, facet morphology, and lumbar facet joint degeneration in adults with chronic low back pain. The study will use lumbar magnetic resonance imaging (MRI) obtained as part of routine clinical care. The study will evaluate whether subcutaneous fat index is associated with moderate-to-severe lumbar facet joint degeneration and will also examine the relationships of disc degeneration, facet morphology, paraspinal muscle characteristics, and pain severity with facet joint degeneration.
Read the detailed description
This is a prospective, non-interventional observational clinical study conducted in patients with chronic low back pain. Participants will be adults aged 18 to 75 years who present to the Algology outpatient clinic of Marmara University Pendik Training and Research Hospital and who have a clinical indication for lumbar MRI as part of routine patient care, independent of study participation.
No additional MRI examinations, radiation exposure, medication administration, injections, or invasive procedures will be performed for research purposes. Participation in the study will not alter the patients' routine diagnostic, treatment, or follow-up procedures.
Demographic and clinical characteristics, including age, sex, height, weight, body mass index, smoking status, diabetes mellitus, hypertension, duration and severity of low back pain, and the presence of leg or radicular pain, will be recorded. Pain severity will be assessed using the Numeric Rating Scale.
Lumbar MRI images obtained during routine clinical care will be evaluated for subcutaneous fat index, intervertebral disc degeneration, facet joint degeneration, facet joint angle and tropism, paraspinal muscle cross-sectional area and fat infiltration, and Modic changes. Subcutaneous fat index will be measured at the L1-L2 level. Intervertebral disc degeneration will be assessed using the Pfirrmann classification, while facet joint degeneration will be assessed using the Weishaupt classification. Facet tropism will be calculated as the absolute difference between the right and left facet joint angles. Paraspinal muscle measurements will be performed at the L3-L4, L4-L5, and L5-S1 levels for the multifidus and erector spinae muscles.
The primary objective is to evaluate the association between subcutaneous fat index and moderate-to-severe lumbar facet joint degeneration. Secondary objectives include evaluating the relationships between subcutaneous fat index and total disc degeneration, disc degeneration and facet joint degeneration, facet morphology and facet joint degeneration, paraspinal muscle characteristics and disc or facet joint degeneration, and subcutaneous fat index and pain severity. An exploratory mediation analysis will also assess the potential mediating role of disc degeneration in the relationship between subcutaneous fat index and facet joint degeneration.
Imaging assessments will be performed by an evaluator blinded to pain severity, body mass index, and other clinical findings. Inter-rater or intra-rater reliability will be assessed in a randomly selected subset of approximately 20% of the study sample.
- Being tested
- Lumbar Magnetic Resonance Imaging (MRI)
- Keywords
- Subcutaneous Fat Index, Paraspinal Muscle, Facet Morphology, Facet Tropism, Intervertebral Disc Degeneration, Lumbar Spine MRI
- Medical subject headings
- Intervertebral Disc Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumbar Magnetic Resonance Imaging (MRI)Diagnostic test
Lumbar MRI images obtained as part of routine clinical care will be evaluated for study purposes. No additional MRI examination or radiation exposure will be performed because of study participation. MRI findings will be assessed for subcutaneous fat index, intervertebral disc degeneration, facet joint degeneration, facet morphology, and paraspinal muscle characteristics.
| Study group | Role | What they receive |
|---|---|---|
| Chronic Low Back Pain Cohort | Participants with chronic low back pain who meet the eligibility criteria and undergo lumbar MRI as part of routine clinical care will be included in this observational cohort. MRI findings and demographic and clinical characteristics will be evaluated to investigate the associations between subcutaneous fat index, paraspinal muscle characteristics, facet morphology, intervertebral disc degeneration, and lumbar facet joint degeneration. Receives: Diagnostic Test: Lumbar Magnetic Resonance Imaging (MRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association between subcutaneous fat index and moderate-to-severe lumbar facet joint degeneration
Moderate-to-severe lumbar facet joint degeneration will be defined as Weishaupt Grade ≥2 in the right or left facet joint at any lumbar level from L1-L2 to L5-S1. The association with subcutaneous fat index measured on lumbar MRI will be evaluated.
Measured: At baseline
Secondary outcomes (6)
Association between subcutaneous fat index and total Pfirrmann score
The association between subcutaneous fat index and total Pfirrmann score for lumbar intervertebral disc degeneration will be evaluated.
Measured: At baseline
Association between intervertebral disc degeneration and facet joint degeneration
The association between intervertebral disc degeneration and lumbar facet joint degeneration will be evaluated using Pfirrmann and Weishaupt classifications.
Measured: At baseline
Association between facet angle, facet tropism, and facet joint degeneration
The associations between facet angle, facet tropism, and lumbar facet joint degeneration will be evaluated.
Measured: At baseline
Association between paraspinal muscle characteristics and intervertebral disc and facet joint degeneration
The associations between paraspinal muscle characteristics, including total cross-sectional area, functional cross-sectional area, and fat infiltration, and intervertebral disc and lumbar facet joint degeneration will be evaluated.
Measured: At baseline
Association between subcutaneous fat index and low back pain severity
The association between subcutaneous fat index and low back pain severity will be evaluated using the Numeric Rating Scale (NRS).
Measured: At baseline
Exploratory mediation analysis of intervertebral disc degeneration in the association between subcutaneous fat index and facet joint degeneration
The potential statistical mediation role of intervertebral disc degeneration in the association between subcutaneous fat index and lumbar facet joint degeneration will be evaluated as an exploratory analysis.
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2026
- Study start1 Sep 2026
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
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.
- 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
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- OSMAN H GÜNDÜZ, Principal investigator, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07860697
- Sponsor's protocol ID
- 09.2026.26-0770
- Status last verified
- Sep 2026
- First submitted
- 30 Sep 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with other researchers because no plan for individual participant data sharing has been established for this study.