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- Ensaio Clínico NCT07917962
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.
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Estimado)
Contactos e Locais
Locais de estudo
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Guangdong
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Guangzhou, Guangdong, China, 510405
- The First Affiliated Hospital of Guanazhou University of Traditional Chinese Mledicine, Guangzhou, Guangdong 510405
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
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.
Descrição
Inclusion Criteria:
- Clinically and radiologically diagnosed with single-level degenerative lumbar spinal stenosis.
- Underwent lumbar CT and MRI examinations.
- 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:
- Multi-level lumbar spinal stenosis.
- History of previous lumbar decompression, fusion, or internal fixation surgery.
- Concomitant lumbar spondylolisthesis or degenerative scoliosis.
- Concomitant spinal tumors, infections, tuberculosis, or fresh fractures.
- Severe medical diseases, mental disorders, or inability to cooperate.
- Missing key baseline clinical parameters.
- Incomplete imaging datasets.
- Time interval between imaging examination and clinical evaluation > 1 month.
- Non-standard MRI scanning protocols.
- Severe spinal deformity affecting standardized measurement.
- Concomitant confounding neurological diseases.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: COHORT
- Perspectivas de Tempo: RETROSPECTIVE
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
|
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. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Correlation Between Imaging Grading and VAS Pain Scores
Prazo: 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)
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Correlation Between Imaging Grading and ODI Scores
Prazo: 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
Prazo: 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)
|
Colaboradores e Investigadores
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Outros números de identificação do estudo
- DWang-FS2026
- JY2026-498J (Outro identificador: Ethics Committee Teaching and Research Branch The First Affiliated Hospital of Guangzhou University of Chinese Medicine)
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