- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06786611
Quantitative Assessment of Lumbar Facet Joint Degeneration, A Retrospective Study.
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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Shanghai
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Shanghai, Shanghai, China, 200003
- Changzheng Hospital, Second Military Medical University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- (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.
Exclusion Criteria:
- (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%.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
"From enrollment to the end of treatment at 1 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Correlation analysis and logistic regression analysis between imaging parameters
Time Frame: "From enrollment to the end of treatment at 1 weeks
|
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.
|
"From enrollment to the end of treatment at 1 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024455
- 2024DZXYY- 105 (Other Identifier: Shanghai Changzheng Hospital)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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