- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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.
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Kontakty a umístění
Studijní místa
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Guangdong
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Guangzhou, Guangdong, Čína, 510405
- The First Affiliated Hospital of Guanazhou University of Traditional Chinese Mledicine, Guangzhou, Guangdong 510405
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
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.
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Observační modely: COHORT
- Časové perspektivy: RETROSPECTIVE
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
|---|---|
|
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. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Correlation Between Imaging Grading and VAS Pain Scores
Časové okno: 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)
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Correlation Between Imaging Grading and ODI Scores
Časové okno: 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
Časové okno: 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)
|
Spolupracovníci a vyšetřovatelé
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
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
Další identifikační čísla studie
- DWang-FS2026
- JY2026-498J (Jiný identifikátor: Ethics Committee Teaching and Research Branch The First Affiliated Hospital of Guangzhou University of Chinese Medicine)
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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