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

Lumbar Disc Herniation Clinical Trial

— ICCLDHPCMSFT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05649592
• Other study ID #: 3568185739
• Status: Completed
• Start date: January 5, 2022
• Est. completion date: November 25, 2022

Study information

• Verified date: December 2022
• Source: ShuGuang Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: November 25, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 55 Years

Eligibility

Inclusion Criteria:

• patients in good physical health; ?patients aged 20 to 55 years, including 20 and 55 years, male or female; ?patients 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; ?patients 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; ?patients intolerant to necessary examinations.

Related Conditions & MeSH terms

• Hernia
• Intervertebral Disc Displacement
• Lumbar Disc Herniation

Intervention

Diagnostic Test:
• Magnetic Resonance Hydrolipid Separation Imaging
MRHS was used to measure different muscle percent fat of core muscles. MRHS, also called Dixon imaging, mainly used the different resonant frequency between the hydrogen nuclei in water and in fat to perform the data acquisition at different echo times (TE). The Dixon sequence basically acquires two images, one image with water and fat signals in-phase and the other with water and fat signals out-of-phase: the sum and subtraction of the two images allow the production of a water-only image and a fat-only image. Scanning equipment: 3.0T superconducting Siemens Skyra Scanner. Scanning parameters: TR5.36ms, TE1.24ms, Flip Angle 9°, number of layers was 44-60, thickness of layer was 5.0 mm, layer interval 1.0mm, FOV50cm×50cm, the scanning time was 12s×5.

Locations

Country	Name	City	State
China	Shuguang Hospital Affiliated with Shanghai University of TCM	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Zhan Yunfan

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	core muscles percent fat	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	baseline
Secondary	Subcutaneous fat tissue thickness	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.	baseline