Subcutaneous Fat, Back Muscles, and Spine Shape in Back Pain Patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective observational study enrolling adults with chronic low back pain who are undergoing lumbar MRI as part of routine care. Researchers will measure subcutaneous fat index, paraspinal muscle characteristics, and facet morphology on MRI, and will relate these findings to facet joint degeneration and pain severity. No extra MRI scans or procedures are performed for research; data collection uses information from standard clinical imaging and visits. Demographic and clinical data, including BMI, smoking, comorbidities, pain scores, and disability measures, will be recorded to explore associations. The study aims to clarify how body composition and spinal anatomy relate to facet joint degeneration.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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Inclusion Criteria:

1. Age 18-75 years.
2. Low back pain lasting for at least 3 months.
3. Evaluation at the Algology outpatient clinic.
4. Lumbar MRI has been clinically indicated as part of routine patient management independently of the study.
5. Lumbar MRI images including sagittal T1-weighted, sagittal T2-weighted, and axial T2-weighted images covering the L1-L2 through L5-S1 levels.
6. Height and body weight can be measured.
7. Low back pain severity can be assessed using the Numeric Rating Scale (NRS).
8. Sufficient cognitive and linguistic capacity to complete the Oswestry Disability Index.
9. Ability to understand the study and provide informed consent.
10. Written informed consent to participate in the study.

Exclusion Criteria:

1. Previous lumbar spine surgery or lumbar fusion.
2. Acute vertebral fracture or significant lumbar trauma.
3. Spinal malignancy or vertebral metastasis.
4. Spondylodiscitis or other spinal infections.
5. Inflammatory spondyloarthritis.
6. Advanced lumbar scoliosis.
7. Severe congenital lumbar vertebral anomaly.
8. Anatomic variation preventing reliable identification of vertebral levels.
9. Pregnancy.
10. Inability to complete the MRI examination.
11. MRI images inadequate for assessment of subcutaneous fat, intervertebral discs, facet joints, or paraspinal muscles.
12. Missing clinical data or required outcome measures.
13. Failure to provide written informed consent.

Exclusion Criteria:

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Where it's running

• Marmara University Pendik Training and Research Hospital
  Istanbul, Istanbul, Turkey (Türkiye) Recruiting

Study contacts

• Principal investigator: Osman H Gündüz — Marmara University
• Study coordinator: Serhat Köse
• Email: serhatkose03@gmail.com
• Phone: 05350150460

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.