Imaging Characteristics of Chronic Lumbar Disc Herniation From the Perspective of Core Muscles and Subcutaneous Fat Tissue Thickness

Completed

• Conditions: Lumbar Disc Herniation
• Interventions: Diagnostic Test: Magnetic Resonance Hydrolipid Separation Imaging

• Registration Number: NCT05649592
• Lead Sponsor: Zhan Yunfan

Brief Summary

Fat infiltration and atrophy of lumbar muscles are related to spinal degenerative conditions, which can be seen reliably on MRI scans of lumbar disc herniation (LDH) patients. The aim of this study was to investigate the relationship between the degeneration of core muscles, obesity and chronic LDH. Fifty-five healthy volunteers and fifty-five chronic LDH patients (the course of the disease is more than six months) were enrolled. Core muscle percent fat and subcutaneous fat tissue thickness(SFTT) were used as the outcome measure, and logistic regression and independent samples t-test as the analytical methods to compare the relationship of the following five independent variables (erector spinae, rectus abdominis, \[transversus abdominal, internal abdominal oblique, and external abdominal oblique muscle\], lumbar multifidus, and psoas major muscles) and SFTT with LDH.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-05
• Primary Completion: 2022-09-30
• Study Completion: 2022-11-25
• Status Verified: 2022-12
• Study First Submitted: 2022-12-06
• Study First Submitted QC: 2022-12-06
• Last Update Submitted: 2022-12-06
• Study First Posted: 2022-12-14
• Last Update Posted: 2022-12-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

• patients in good physical health; ②patients aged 20 to 55 years, including 20 and 55 years, male or female; ③patients who agree to participate in the study and sign the informed consent.

Exclusion criteria:

• patients who performed lumbar and abdominal muscles exercises in the past; ②patients unable to tolerate magnetic resonance imaging or claustrophobia;

  • patients who are deemed unsuitable for the clinical trial.

Removing criteria:

• patients who decline participation of various reasons;

  • patients unable to comprehend questions asked by the researchers; ③patients intolerant to necessary examinations.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Lumbar disc herniation patients	Magnetic Resonance Hydrolipid Separation Imaging	-
healthy volunteers	Magnetic Resonance Hydrolipid Separation Imaging	-

Primary Outcome Measures

Name	Time	Method
core muscles percent fat	baseline	Magnetic resonance imaging-guided core muscles percent fat in patients with chronic LDH and healthy volunteers, including erector spinae, rectus abdominis, (transversus abdominal, internal abdominal oblique, and external abdominal oblique muscle), lumbar multifidus, and psoas major muscles was used as the outcome measure

Secondary Outcome Measures

Name	Time	Method
Subcutaneous fat tissue thickness	baseline	Subcutaneous fat tissue thickness(SFTT) was measured as the vertical distance from the tip of spinous process to the skin on axial T2-weighted lumbar spine MRI.

Trial Locations

Locations (1)

Shuguang Hospital Affiliated with Shanghai University of TCM; 🇨🇳 Shanghai, China