- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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.
Studieoversigt
Status
Intervention / Behandling
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
Tilmelding (Anslået)
Kontakter og lokationer
Studiesteder
-
-
Guangdong
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Guangzhou, Guangdong, Kina, 510405
- The First Affiliated Hospital of Guanazhou University of Traditional Chinese Mledicine, Guangzhou, Guangdong 510405
-
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
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:
- 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.
Studieplan
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
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
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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