Association of Subcutaneous Fat Index, Paraspinal Muscle Characteristics, and Facet Morphology With Lumbar Facet Joint Degeneration
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.
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Kontakty a umístění
Studijní kontakt
- Jméno: Serhat Köse
- Telefonní číslo: 05350150460
- E-mail: serhatkose03@gmail.com
Studijní místa
-
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Istanbul
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Istanbul, Istanbul, Turecko (Türkiye), 34890
- Nábor
- Marmara University Pendik Training and Research Hospital
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Kontakt:
- Serhat Köse
- Telefonní číslo: 05350150460
- E-mail: serhatkose03@gmail.com
-
Vrchní vyšetřovatel:
- Osman Hakan Gündüz, Prof.Dr.
-
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
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.
Popis
Inclusion Criteria:
-
Inclusion Criteria:
- 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.
- 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.
Exclusion Criteria:
- 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.
- 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.
Exclusion Criteria:
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Studijní plán
Jak je studie koncipována?
Detaily designu
- Observační modely: COHORT
- Časové perspektivy: PROSPECTIVE
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
|---|---|
|
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. |
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. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Association between subcutaneous fat index and moderate-to-severe lumbar facet joint degeneration
Časové okno: At baseline
|
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. |
At baseline
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Association between subcutaneous fat index and total Pfirrmann score
Časové okno: At baseline
|
The association between subcutaneous fat index and total Pfirrmann score for lumbar intervertebral disc degeneration will be evaluated. |
At baseline
|
|
Association between intervertebral disc degeneration and facet joint degeneration
Časové okno: At baseline
|
The association between intervertebral disc degeneration and lumbar facet joint degeneration will be evaluated using Pfirrmann and Weishaupt classifications. |
At baseline
|
|
Association between facet angle, facet tropism, and facet joint degeneration
Časové okno: At baseline
|
The associations between facet angle, facet tropism, and lumbar facet joint degeneration will be evaluated. |
At baseline
|
|
Association between paraspinal muscle characteristics and intervertebral disc and facet joint degeneration
Časové okno: At baseline
|
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. |
At baseline
|
|
Association between subcutaneous fat index and low back pain severity
Časové okno: At baseline
|
The association between subcutaneous fat index and low back pain severity will be evaluated using the Numeric Rating Scale (NRS). |
At baseline
|
|
Exploratory mediation analysis of intervertebral disc degeneration in the association between subcutaneous fat index and facet joint degeneration
Časové okno: At baseline
|
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. |
At baseline
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: OSMAN H GÜNDÜZ, Marmara University
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 09.2026.26-0770
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Individual participant data will not be shared with other researchers because no plan for individual participant data sharing has been established for this study.
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