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Clinical Trials/NCT05649592
NCT05649592
Completed
Not Applicable

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

Zhan Yunfan1 site in 1 country110 target enrollmentJanuary 5, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Lumbar Disc Herniation
Sponsor
Zhan Yunfan
Enrollment
110
Locations
1
Primary Endpoint
core muscles percent fat
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 5, 2022
End Date
November 25, 2022
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Zhan Yunfan
Responsible Party
Sponsor Investigator
Principal Investigator

Zhan Yunfan

ShuGuang Hospita

ShuGuang Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

  • Subcutaneous fat tissue thickness(baseline)

Study Sites (1)

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