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Completed

NCT Number: NCT05649592

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

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.

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Key information

Age range

20 year–55 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Shuguang Hospital Affiliated with Shanghai University of TCM

Shanghai, 201203, China

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

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.

Primary outcomes

  1. core muscles percent fat

    Time frame: 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 outcomes

  1. Subcutaneous fat tissue thickness

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Zhan Yunfan

Other

Registry information

Official study title

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

Acronym: ICCLDHPCMSFT

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Dec 14, 2022
Registry last updated
Dec 14, 2022

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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