The Effect Of Low Back Pain on Paraspinal Muscles

Status Completed

Clinical Trial Summary

Low back pain is frequently seen in the adolescent age group, with a prevalence approaching that of the adult age group. The most common type is non-specific, self-limiting low back pain. LDH is rare in children and adolescents and generally presents with low back pain, with or without radiculopathy. The condition is usually unilateral (especially L4-5 or L5-S1). LDH is also mostly central type. Although there are many studies that have investigated the relationship between paraspinal muscle volumes and LBP and/or LDH in the adult age group, there are very few studies in adolescents. The principal aim of this study was to compare MF, ES, and PM volumes in adolescents with LBP with and without LDH using magnetic resonance imaging (MRI) and to determine whether these two conditions cause paraspinal muscle volume loss.

Clinical Trial Description

The medical records of 229 patients who underwent MRI due to low back pain persisting for a minimum of twelve weeks between January 2018 and January 2020 were evaluated retrospectively. Twenty-four patients were excluded due to the presence of spondylolysis-listhesis, spinal alignment disorders including scoliosis and kyphosis, inflammatory diseases, or histories of spinal surgery and multilevel disc hernia. Two hundred five patients were finally enrolled. Age, gender, weight, and height were recorded, and BMI was calculated as weight/(height)². Participants were divided into two groups - with LDH (Group A) and without LDH (Group B). Right- and left-side PS, MF, and ES muscle volumes at intervertebral disc levels L4-L5 and L5-S1 were measured on Axial T2-weighted fast spin-echo sequences. All cross-sectional images at both levels (L4-5 and L5-S1) were generated by means of multiplanar reformat images. The muscles were identified by means of manual contouring at both disc levels. The fat components were then eliminated by application of the threshold technique, based on visual differences in pixel signal intensities. Volume measurement from cross-sectional images was based on the use of an automatic volume calculation tool. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04555356
Study type	Observational
Source	Fatih Sultan Mehmet Training and Research Hospital
Contact
Status	Completed
Phase
Start date	January 1, 2018
Completion date	January 1, 2020

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.