NCT06786611

Brief 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. 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2020

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 16, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 22, 2025

Completed
Last Updated

January 22, 2025

Status Verified

January 1, 2025

Enrollment Period

3.9 years

First QC Date

January 16, 2025

Last Update Submit

January 16, 2025

Conditions

Keywords

facet joint degenerationlow back painWeishaupt grading systemGrayscale curve fitting

Outcome Measures

Primary Outcomes (1)

  • 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.

    "From enrollment to the end of treatment at 1 weeks

Secondary Outcomes (1)

  • Correlation analysis and logistic regression analysis between imaging parameters

    "From enrollment to the end of treatment at 1 weeks

Study Arms (1)

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.

Diagnostic Test: MRI

Interventions

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.

facet joint degeneration

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who underwent imaging examination in Shanghai Changzheng Hospital from September 2020 to July 2024 to evaluate lumbar joint degeneration were included.

You may qualify if:

  • (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.

You may not qualify if:

  • (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%.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Changzheng Hospital, Second Military Medical University

Shanghai, Shanghai Municipality, 200003, China

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2025

First Posted

January 22, 2025

Study Start

September 1, 2020

Primary Completion

July 31, 2024

Study Completion

July 31, 2024

Last Updated

January 22, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

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.

Locations