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Clinical Trial Summary

Nerve compression due to lumbar disc herniation and related radicular pain is a very common condition when the lifetime prevalence is considered. Lumbosacral radicular pain can be defined as pain originating from the lumbar level and spreading to the lower extremities along the distribution area of one or more spinal nerves. It is thought that the mechanical pressure of the disc material herniated to the dorsal nerve root or ganglion or the inflammation created by the chemokines and enzymes in the disc are involved in the pain formation mechanism. Various methods such as medical agents, physical therapy modalities, epidural steroid injections and surgical methods can be used in the treatment of the related condition. Epidural injections have been used for the treatment of lower back and lower extremity pain since about 1900. Epidural injections exert their effects through the anti-inflammatory and neural membrane stabilizing effects of steroids, as well as by local anesthetics increasing blood flow to the ischemic spinal root and by the removal of cytokines from the area by the injection material. Epidural injections can be performed with various different approaches, including caudal, interlaminar and transforaminal. Among these approaches, the transforaminal approach is the most recently developed approach in the late 1990s, which allows drugs to be administered directly to the pathology area. The effect of obesity, which is one of the factors thought to predispose to low back pain and lumbosacral radicular pain, has been evaluated in various studies and it has been found that it is positively correlated with low back pain and is an independent risk factor for lumbar herniation. So, does obesity have an effect on the success of transforaminal epidural steroid injection treatment? According to the literature, no significant effect on treatment success has been demonstrated. Although the body mass index, which is used in the evaluation of obesity, has provided us important information about the health of the person in general for a long time, it is now thought to lead to an incomplete assessment. Because it does not provide information about body composition ratios (fat amount / lean body mass). Studies have shown that there is a high correlation between the percentage of body fat and the thickness of the subcutaneous fat tissue in the lumbar region, and there is a significant relationship between the lumbar region subcutaneous fat tissue thickness (especially L1-L2 level) and the degree of intervertebral disc degeneration and vertebral surface change. From this point of view, in another study, the L1-L2 disc level subcutaneous fat tissue thickness, was called the subcutaneous fat index, and the cut-off values that showed a significant relationship with spinal degeneration were determined. In the study we planned, in cases of spinal radicular pain (etiologically caused by intervertebral disc herniation), body mass index, lumbar level subcutaneous fat tissue thickness and subcutaneous fat index data whether be or be not correlated with treatment effectiveness/success in patients who received transforaminal epidural steroid injection, and if so, the level of significance intended to work. Before applying for surgery, we aim to develop a practical approach that can be used by relevant clinicians and contribute to the literature, which can predict 'what level of treatment success can we achieve in which patient?' with this injection method.


Clinical Trial Description

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Study Design


Related Conditions & MeSH terms


NCT number NCT05556538
Study type Observational
Source Marmara University
Contact
Status Completed
Phase
Start date October 10, 2022
Completion date August 11, 2023

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