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

NCT05649592 | Completed FDA Device

• 1 other identifier: 3568185739
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Lumbar Disc Herniation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Subcutaneous fat tissue thickness

  baseline

Study Arms (2)

Lumbar disc herniation patients

Diagnostic Test: Magnetic Resonance Hydrolipid Separation Imaging

healthy volunteers

Diagnostic Test: Magnetic Resonance Hydrolipid Separation Imaging

Interventions

Magnetic Resonance Hydrolipid Separation Imaging DIAGNOSTIC_TEST

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; healthy volunteers

Eligibility Criteria

• Age: 20 Years - 55 Years
• Gender Eligibility Details: patients and healthy volunteers aged 20 to 55 years, including 20 and 55 years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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;

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhan Yunfan: lead

Study Sites (1)

Shuguang Hospital Affiliated with Shanghai University of TCM

Shanghai, 201203, China

Location

MeSH Terms

Conditions

Intervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: ShuGuang Hospita

Study Record Dates

• First Submitted: December 6, 2022
• First Posted: December 14, 2022
• Study Start: January 5, 2022
• Primary Completion: September 30, 2022
• Study Completion: November 25, 2022
• Last Updated: December 14, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)