Facet Joint Pain; Low Back PainNCT06786611
Quantitative Assessment of Lumbar Facet Joint Degeneration, A Retrospective Study.
An observational study of Facet Joint Pain; Low Back Pain and Facet Joints; Degeneration ; Deep Learning ;Artificial Intelligence, run by Shanghai Changzheng Hospital at 1 site in China.
Trial summary
Observational study The purpose of this observational study was to understand the quantitative assessment of the degree of degeneration of lumbar facet joints, and to improve the Weishaupt grading system by using gray-scale curve fitting and imaging parameters. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Facet Joint Pain; Low Back Pain, Facet Joints; Degeneration ; Deep Learning ;Artificial Intelligence, Facet Joint Disease
- What is being tested?
- MRI
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2020to 31 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who underwent imaging examination in Shanghai Changzheng Hospital from September 2020 to July 2024 to evaluate lumbar joint degeneration were included.
Who may be able to join
- (1) Age range from 20 to 80 years old; (2) Persisted chronic low back pain (CLBP) more than 12 weeks; (3) Complete preoperative X-ray and 1.5T MRI examination.
Who cannot join
- (1) Scoliosis, Cobb angle>20°; (2) Lack of preoperative X-ray or MRI examination; (3) 3.0T MRI; (4) The interval between preoperative X-ray and MRI examinations is more than one month; (5) Previous lumbar spine internal fixation surgery; (6) Lumbar spondylolisthesis > 5 mm, with severe dislocation of facet joints; (7) Intravertebral bone cement implantation; (8) Severe spinal joint disease (e.g. mandatory spondylitis); (9) Spinal tumors; (10) The maximum extension depth of Modic changes (MC) relative to vertebral body height was greater than 25%.
Trial locations and contacts
1 site in 1 country.
China1 site
Changzheng Hospital, Second Military Medical University
Shanghai, Shanghai Municipality, 200003
About this study
Official title: Enhanced Quantitative Assessment of Lumbar Facet Joint Degeneration: Refining the Weishaupt Grading System With Grayscale Curve Fitting and Imaging Parameter.
Observational study
The purpose of this observational study was to understand the quantitative assessment of the degree of degeneration of lumbar facet joints, and to improve the Weishaupt grading system by using gray-scale curve fitting and imaging parameters.
The main questions it aims to answer are: How to realize quantitative analysis of lumbar facet joint degeneration in patients with chronic low back pain with MRI?
The MRI information of patients with different grades of articular process joint degeneration has been statistically summarized in nearly 5 years
- Conditions
- Facet Joint Pain; Low Back Pain, Facet Joints; Degeneration ; Deep Learning ;Artificial Intelligence, Facet Joint Disease
- Being tested
- MRI
- Keywords
- facet joint degeneration, low back pain, Weishaupt grading system, Grayscale curve fitting
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDiagnostic test
Based on the different manifestations of facet joints under MRI, and with the help of the characteristic manifestations of the gray value curve of facet joints under different subtypes, the curve of facet joints under the same level is fitted, and finally the accurate evaluation of different subtypes of small joints is achieved.
| Study group | Role | What they receive |
|---|---|---|
| facet joint degeneration | based on the Weishaput grading system, we classified all included patients into the facet joint degeneration group and divided them into four subtypes according to different grades. Receives: Diagnostic Test: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Grayscale Curve Fitting
Based on the signal intensity changes of T2-weighted of 1.5T MRI in different degenerative grades of facet joints, the gray value changes in facet joints were measured and fitted.
Measured: "From enrollment to the end of treatment at 1 weeks
Secondary outcomes (1)
Correlation analysis and logistic regression analysis between imaging parameters
Imaging parameters such as intervertebral space height (ISH), lumbar range of motion (ROM-L), intervertebral disc degeneration, facet joint degeneration, facet joint area, vertebral bone quality (VBQ) scores, subcutaneous fat tissue thickness (SFTT) and grayscale values of lumbar facet joint were analyzed. Statistical correlations were evaluated using spearman rank correlation and ordinal logistic regression.
Measured: "From enrollment to the end of treatment at 1 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2025
- Study start1 Sep 2020
- Primary completion31 Jul 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Facet Joint Pain; Low Back PainStudies of the same condition, open and under way.
- More trials run by Shanghai Changzheng HospitalThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Changzheng Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06786611
- Sponsor's protocol ID
- 2024455
- Other IDs
- 2024DZXYY- 105
- Status last verified
- Jan 2025
- First submitted
- 16 Jan 2025
- Last updated
- 22 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: As the data involves the personal privacy of patients in our hospital, it is considered not to be published as public data. You can apply with the person in charge of this study for reasonable demands.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced Quantitative Assessment of Lumbar Facet Joint Degeneration: Refining the Weishaupt Grading System With Grayscale Curve Fitting and Imaging Parameter.
- ClinicalTrials.gov ID
- NCT06786611
- Acronym / sponsor ID
- 2024455
- Conditions
- Facet Joint Pain; Low Back Pain, Facet Joints; Degeneration ; Deep Learning ;Artificial Intelligence, Facet Joint Disease
- Keywords
- facet joint degeneration, low back pain, Weishaupt grading system, Grayscale curve fitting
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Shanghai Changzheng HospitalUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 22 Jan 2025 (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.
Observational study
The purpose of this observational study was to understand the quantitative assessment of the degree of degeneration of lumbar facet joints, and to improve the Weishaupt grading system by using gray-scale curve fitting and imaging parameters.
The main questions it aims to answer are: How to realize quantitative analysis of lumbar facet joint degeneration in patients with chronic low back pain with MRI?
The MRI information of patients with different grades of articular process joint degeneration has been statistically summarized in nearly 5 years
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| facet joint degeneration | – | Diagnostic Test: MRIbased on the Weishaput grading system, we classified all included patients into the facet joint degeneration group and divided them into four subtypes according to different grades. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent imaging examination in Shanghai Changzheng Hospital from September 2020 to July 2024 to evaluate lumbar joint degeneration were included.
Key inclusion criteria (1 listed)
- (1) Age range from 20 to 80 years old; (2) Persisted chronic low back pain (CLBP) more than 12 weeks; (3) Complete preoperative X-ray and 1.5T MRI examination.
Key exclusion criteria (1 listed)
- (1) Scoliosis, Cobb angle>20°; (2) Lack of preoperative X-ray or MRI examination; (3) 3.0T MRI; (4) The interval between preoperative X-ray and MRI examinations is more than one month; (5) Previous lumbar spine internal fixation surgery; (6) Lumbar spondylolisthesis > 5 mm, with severe dislocation of facet joints; (7) Intravertebral bone cement implantation; (8) Severe spinal joint disease (e.g. mandatory spondylitis); (9) Spinal tumors; (10) The maximum extension depth of Modic changes (MC) relative to vertebral body height was greater than 25%.
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 |
|---|---|---|
| MRIBased on the different manifestations of facet joints under MRI, and with the help of the characteristic manifestations of the gray value curve of facet joints under different subtypes, the curve of facet joints under the same level is fitted, and finally the accurate evaluation of different subtypes of small joints is achieved. | Diagnostic test | facet joint degeneration |
Primary outcome
Grayscale Curve Fitting
Time frame: "From enrollment to the end of treatment at 1 weeks
Based on the signal intensity changes of T2-weighted of 1.5T MRI in different degenerative grades of facet joints, the gray value changes in facet joints were measured and fitted.
1 secondary outcome
Correlation analysis and logistic regression analysis between imaging parameters
Time frame: "From enrollment to the end of treatment at 1 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2025.
- Individual participant dataSharing planned: No. As the data involves the personal privacy of patients in our hospital, it is considered not to be published as public data. You can apply with the person in charge of this study for reasonable demands.
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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. This study is not recruiting at the moment.
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 Facet Joint Pain; Low Back Pain and Facet Joints; Degeneration ; Deep Learning ;Artificial Intelligence, run by Shanghai Changzheng Hospital 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 22 Jan 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Grayscale Curve Fitting (time frame: "From enrollment to the end of treatment at 1 weeks). 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 22 Jan 2025.