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Not yet recruitingNCT07917962Updated Nov 9, 2026

Foraminal Imaging and Symptoms in Single-Level Degenerative Lumbar Stenosis

An observational study in Degenerative Lumbar Spinal Stenosis and Lumbar Foraminal Stenosis, sponsored by The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-09.

Sponsored by The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine · Observational

Updated Nov 5, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
120
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Degenerative Lumbar Spinal Stenosis
  • Lumbar Foraminal Stenosis
03

In context

Constriction, Pathologic

456 studies on the registry are indexed under Constriction, Pathologic; 109 are open to participants now.

This study's planned enrollment of 120 is above the median of 84 across 144 observational studies indexed under Constriction, Pathologic.

Browse Constriction, Pathologic studies →

Lead sponsor

The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine is the lead sponsor of 11 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
120 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

    Other: No Intervention: Observational Cohort

  • 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.

    Other: No Intervention: Observational Cohort

  • 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.

    Other: No Intervention: Observational Cohort

Interventions

  • OtherNo Intervention: Observational Cohort

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

06

What researchers measure

Primary outcomes

  1. Correlation Between Imaging Grading and VAS Pain Scores

    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.

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

Secondary outcomes

  1. Correlation Between Imaging Grading and ODI Scores

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

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

  2. Factors Independently Associated with Symptom Severity

    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.

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

07

Study locations

1 site
  • The First Affiliated Hospital of Guanazhou University of Traditional Chinese Mledicine, Guangzhou, Guangdong 510405
    Guangzhou, Guangdong 510405, China
08

Updates

2 registry updates since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Nov 5, 2026
Show all 2 updates
  1. Nov 9, 2026
    Minor edits only
    + 1 other change: responsible party
  2. Nov 5, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07917962
Lead sponsor
The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
Responsible party
Dongping Wang (Principal Investigator, The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine) — Principal investigator
First posted
Nov 5, 2026
Start date
Oct 29, 2026 (estimated)
Primary completion
Dec 31, 2026 (estimated)
Completion
Sep 30, 2027 (estimated)
Last update
Nov 9, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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