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Completed

NCT Number: NCT06786611

Quantitative Assessment of Lumbar Facet Joint Degeneration, A Retrospective Study.

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

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Key information

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Changzheng Hospital, Second Military Medical University

Shanghai, Shanghai Municipality, 200003, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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%.

Treatment and study plan

MRI

Diagnostic 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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Shanghai Changzheng Hospital

Other

Registry information

Official study title

Enhanced Quantitative Assessment of Lumbar Facet Joint Degeneration: Refining the Weishaupt Grading System With Grayscale Curve Fitting and Imaging Parameter.

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Jan 22, 2025
Registry last updated
Jan 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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