Degenerative Lumbar Spinal StenosisNCT07917962
Foraminal Imaging and Symptoms in Single-Level Degenerative Lumbar Stenosis
An observational study of Degenerative Lumbar Spinal Stenosis and Lumbar Foraminal Stenosis, run by The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Degenerative Lumbar Spinal Stenosis, Lumbar Foraminal Stenosis
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 29 Oct 2026to 30 Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The First Affiliated Hospital of Guanazhou University of Traditional Chinese Mledicine, Guangzhou, Guangdong 510405
Guangzhou, Guangdong, 510405
About this study
Official title: 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.
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.
- Being tested
- No Intervention: Observational Cohort
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Intervention: Observational CohortOther
This is a retrospective observational study using existing medical records and imaging data. No treatments, drugs, or interventions were administered to the participants.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: No Intervention: Observational Cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (at index imaging; single time-point cross-sectional assessment)
Secondary outcomes (2)
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.
Measured: Baseline (at index imaging; single time-point cross-sectional assessment)
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.
Measured: Baseline (at index imaging; single time-point cross-sectional assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2026
- Study start29 Oct 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Lumbar Spinal StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dongping Wang, The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07917962
- Sponsor's protocol ID
- DWang-FS2026
- Other IDs
- JY2026-498J
- Status last verified
- Oct 2026
- First submitted
- 30 Oct 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Analysis Between Foraminal Imaging Morphology and Clinical Symptoms in Patients With Single-Level Degenerative Lumbar Spinal Stenosis
- ClinicalTrials.gov ID
- NCT07917962
- Acronym / sponsor ID
- DWang-FS2026
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital, Guangzhou University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 29 Oct 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 5 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mild Group | – | Other: No Intervention: Observational CohortPatients with a Visual Analog Scale (VAS) pain score of 1-3 (n=40). This is a retrospective observational group with no interventions. |
| Moderate Group | – | Other: No Intervention: Observational CohortPatients with a Visual Analog Scale (VAS) pain score of 4-7 (n=40). This is a retrospective observational group with no interventions. |
| Severe Group | – | Other: No Intervention: Observational CohortPatients with a Visual Analog Scale (VAS) pain score of 8-10 (n=40). This is a retrospective observational group with no interventions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No Intervention: Observational CohortThis is a retrospective observational study using existing medical records and imaging data. No treatments, drugs, or interventions were administered to the participants. | Other | Mild Group, Moderate Group, Severe Group |
Primary outcome
Correlation Between Imaging Grading and VAS Pain Scores
Time frame: 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.
2 secondary outcomes
Correlation Between Imaging Grading and ODI Scores
Time frame: Baseline (at index imaging; single time-point cross-sectional assessment)
Factors Independently Associated with Symptom Severity
Time frame: Baseline (at index imaging; single time-point cross-sectional assessment)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Degenerative Lumbar Spinal Stenosis and Lumbar Foraminal Stenosis, run by The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation Between Imaging Grading and VAS Pain Scores (time frame: Baseline (at index imaging; single time-point cross-sectional assessment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.