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

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

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.

Study Overview

• Status: Completed
• Conditions: Lumbar Disc Herniation
• Intervention / Treatment: Diagnostic test: Magnetic Resonance Hydrolipid Separation Imaging

• Study Type: Observational
• Enrollment (Actual): 110

Contacts and Locations

Study Locations

• China
  • Shanghai, China, 201203
    • Shuguang Hospital Affiliated with Shanghai University of TCM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 53 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Inclusion Criteria:

①patients who meet the diagnostic criteria for LDH based on overall consideration of their symptoms, signs, and radiological findings (MRI)； ②patients aged 20 to 55 years, including 20 and 55 years, male or female; ③Patients with a history of LDH for 6 months and/or above; ④patients who have signed the informed consent.

Exclusion criteria:

①patients with LDH causing radiculopathy or cauda equina syndrome; ②patients with other diseases such as spinal stenosis, ankylosing spondylitis that causes low back pain; ③patients with a previous history of spinal surgery, traumatic injury to the spine; ④patients with bone tuberculosis, osteoporosis and bone tumors; ⑤patients with other severe cardiovascular and cerebrovascular diseases, digestive and hematopoietic system diseases; patients with diabetes mellitus Autoimmune diseases or other metabolic diseases; patients with mental diseases;

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
healthy volunteers	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.
Lumbar disc herniation patients	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Zhan Yunfan

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2022
• Primary Completion (Actual): September 30, 2022
• Study Completion (Actual): November 25, 2022

Study Registration Dates

• First Submitted: December 6, 2022
• First Submitted That Met QC Criteria: December 6, 2022
• First Posted (Estimate): December 14, 2022

Study Record Updates

• Last Update Posted (Estimate): December 14, 2022
• Last Update Submitted That Met QC Criteria: December 6, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Hernia; Intervertebral Disc Displacement
• Other Study ID Numbers: 3568185739

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes