Clinical trial NCT05649592: Imaging Characteristics of Chronic Lumbar Disc Herniation From the Perspective of Core Muscles and Subcutaneous Fat Tissue Thickness
Official title: Imaging Characteristics of Chronic Lumbar Disc Herniation From the Perspective of Core Muscles and Subcutaneous Fat Tissue Thickness: an Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lumbar Disc Herniation
Lead sponsor: ShuGuang Hospital
Sponsor class: OTHER
First posted: 2022-12-14
Enrollment: 110
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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;

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.


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.

Primary outcomes:
measure: core muscles percent fat
timeFrame: baseline
Secondary outcomes:
measure: Subcutaneous fat tissue thickness
timeFrame: baseline
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shuguang Hospital Affiliated with Shanghai University of TCM
Study officials:
References: