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Foraminal Imaging and Symptoms in Single-Level Degenerative Lumbar Stenosis

Correlation Analysis Between Foraminal Imaging Morphology and Clinical Symptoms in Patients With Single-Level Degenerative Lumbar Spinal Stenosis

This retrospective observational study investigated the correlation between foraminal imaging morphology (evaluated by MRI 4-level score and CT Haleem-Botchu classification) and the severity of clinical symptoms in patients with single-level degenerative lumbar spinal stenosis. A total of 120 adult patients treated between January 2024 and December 2025 were included. Patients were categorized into mild, moderate, and severe groups based on their Visual Analog Scale (VAS) scores. The study analyzed the correlation of imaging grades with clinical functional scores (ODI and VAS) and identified independent imaging factors associated with symptom severity. No new treatments or extra hospital visits were involved.

Studieoversigt

Status

Ikke rekrutterer endnu

Detaljeret beskrivelse

To ensure data validity, two independent radiologists, who were blinded to the patients' clinical information and grouping, evaluated the imaging grades at the responsible segment on the symptomatic side. Inter-observer reliability was assessed using the weighted Kappa coefficient.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

120

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Guangdong
      • Guangzhou, Guangdong, Kina, 510405
        • The First Affiliated Hospital of Guanazhou University of Traditional Chinese Mledicine, Guangzhou, Guangdong 510405

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

This retrospective cohort study initially screened 289 consecutive patients diagnosed with single-level degenerative lumbar spinal stenosis between January 2024 and December 2025. After applying strict inclusion and exclusion criteria, a final cohort of 151 eligible patients was established. From this cohort, a stratified sampling method was applied to select 120 patients (40 patients per group) to ensure balanced statistical power, categorizing them into mild (VAS 1-3), moderate (VAS 4-7), and severe (VAS 8-10) symptom groups based on their baseline Visual Analog Scale (VAS) scores. Clinical and imaging data were extracted for correlation and regression analysis.

Beskrivelse

Inclusion Criteria:

  1. Clinically and radiologically diagnosed with single-level degenerative lumbar spinal stenosis.
  2. Underwent lumbar CT and MRI examinations.
  3. Availability of both lumbar CT and MRI examinations of evaluable quality for foraminal morphology assessment (including Haleem-Botchu CT classification and MRI 4-level score).

Exclusion Criteria:

  1. Multi-level lumbar spinal stenosis.
  2. History of previous lumbar decompression, fusion, or internal fixation surgery.
  3. Concomitant lumbar spondylolisthesis or degenerative scoliosis.
  4. Concomitant spinal tumors, infections, tuberculosis, or fresh fractures.
  5. Severe medical diseases, mental disorders, or inability to cooperate.
  6. Missing key baseline clinical parameters.
  7. Incomplete imaging datasets.
  8. Time interval between imaging examination and clinical evaluation > 1 month.
  9. Non-standard MRI scanning protocols.
  10. Severe spinal deformity affecting standardized measurement.
  11. Concomitant confounding neurological diseases.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: COHORT
  • Tidsperspektiver: RETROSPECTIVE

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Mild Group

Patients with a Visual Analog Scale (VAS) pain score of 1-3 (n=40). This is a retrospective observational group with no interventions.

This is a retrospective observational study using existing medical records and imaging data. No treatments, drugs, or interventions were administered to the participants.

Moderate Group

Patients with a Visual Analog Scale (VAS) pain score of 4-7 (n=40). This is a retrospective observational group with no interventions.

This is a retrospective observational study using existing medical records and imaging data. No treatments, drugs, or interventions were administered to the participants.

Severe Group

Patients with a Visual Analog Scale (VAS) pain score of 8-10 (n=40). This is a retrospective observational group with no interventions.

This is a retrospective observational study using existing medical records and imaging data. No treatments, drugs, or interventions were administered to the participants.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Correlation Between Imaging Grading and VAS Pain Scores
Tidsramme: Baseline (at index imaging; single time-point cross-sectional assessment)

The correlation between the severity of foraminal stenosis (assessed by MRI 4-level score and CT Haleem-Botchu classification) and Visual Analog Scale (VAS) pain scores in patients with single-level degenerative lumbar spinal stenosis. The association was analyzed using the Spearman rank correlation coefficient.

Baseline (at index imaging; single time-point cross-sectional assessment)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Correlation Between Imaging Grading and ODI Scores
Tidsramme: Baseline (at index imaging; single time-point cross-sectional assessment)

The correlation between foraminal imaging morphology and Oswestry Disability Index (ODI) scores. The association was analyzed using the Spearman rank correlation coefficient.

Baseline (at index imaging; single time-point cross-sectional assessment)
Factors Independently Associated with Symptom Severity
Tidsramme: Baseline (at index imaging; single time-point cross-sectional assessment)

Multivariable ordinal logistic regression was used to identify independent imaging factors (MRI and CT grading) associated with clinical symptom severity, adjusting for baseline characteristics such as age, gender, and symptom duration.

Baseline (at index imaging; single time-point cross-sectional assessment)

Samarbejdspartnere og efterforskere

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Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

29. oktober 2026

Primær færdiggørelse (Anslået)

31. december 2026

Studieafslutning (Anslået)

30. september 2027

Datoer for studieregistrering

Først indsendt

30. oktober 2026

Først indsendt, der opfyldte QC-kriterier

30. oktober 2026

Først opslået (Faktiske)

5. november 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. oktober 2026

Sidst verificeret

1. oktober 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • DWang-FS2026
  • JY2026-498J (Anden identifikator: Ethics Committee Teaching and Research Branch The First Affiliated Hospital of Guangzhou University of Chinese Medicine)

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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