NCT05556538

The Effect of Subcutaneous Fat Tissue Thickness on Lumbar Transforaminal Epidural Steroid Injection Treatment Success

Completed Last updated 12 April 2024

What this trial tests

trial testing Transforaminal Epidural Steroid Injection in Lumbar Disc Herniation in 52 participants. Completed in 11 August 2023.

Timeline

10 October 2022

Primary endpoint
11 May 2023

11 August 2023

Quick facts

Lead sponsor	Marmara University
Status	Completed
Study type	OBSERVATIONAL
Enrollment	52
Start date	10 October 2022
Primary completion	11 May 2023
Estimated completion	11 August 2023
Sites	1 location across Turkey (Türkiye)

Drugs / interventions tested

• Transforaminal Epidural Steroid Injection — full drug profile →

Conditions studied

• Lumbar Disc Herniation — all drugs for Lumbar Disc Herniation →
• Radiculopathy Lumbar — all drugs for Radiculopathy Lumbar →
• Obesity — all drugs for Obesity →

Sponsor

Marmara University

Who can join

Adults 18 to 65, any sex, with Lumbar Disc Herniation or Radiculopathy Lumbar. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.