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Association of Subcutaneous Fat Index, Paraspinal Muscle Characteristics, and Facet Morphology With Lumbar Facet Joint Degeneration

30. september 2026 oppdatert av: Marmara University

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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Antatt)

300

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Tyrkia (Türkiye)
    • Istanbul
      • Istanbul, Istanbul, Tyrkia (Türkiye), 34890
        • Rekruttering
        • Marmara University Pendik Training and Research Hospital
        • Ta kontakt med:
        • Hovedetterforsker:
          • Osman Hakan Gündüz, Prof.Dr.

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 75 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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.

Beskrivelse

Inclusion Criteria:

-

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:

-

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Observasjonsmodeller: COHORT
  • Tidsperspektiver: PROSPECTIVE

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
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.
Diagnostisk test: Lumbar Magnetic Resonance Imaging (MRI)

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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Association between subcutaneous fat index and moderate-to-severe lumbar facet joint degeneration
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Association between subcutaneous fat index and total Pfirrmann score
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Marmara University

Etterforskere

  • Hovedetterforsker: OSMAN H GÜNDÜZ, Marmara University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. september 2026

Primær fullføring (Antatt)

1. juni 2027

Studiet fullført (Antatt)

1. juni 2027

Datoer for studieregistrering

Først innsendt

30. september 2026

Først innsendt som oppfylte QC-kriteriene

30. september 2026

Først lagt ut (Faktiske)

6. oktober 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

6. oktober 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

30. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 09.2026.26-0770

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

Individual participant data will not be shared with other researchers because no plan for individual participant data sharing has been established for this study.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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