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Clinical Trials/NCT05601791
NCT05601791
Recruiting
Not Applicable

Efficacy of Percutaneous Laser Disc Decompression Versus Epidural Steroid and Local Anesthetic Injection by Transforaminal Approach in the Treatment of Lumbar Radicular Pain

Osijek University Hospital1 site in 1 country116 target enrollmentNovember 30, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Herniated Disc
Sponsor
Osijek University Hospital
Enrollment
116
Locations
1
Primary Endpoint
Compare the effectiveness in reducing pain intensity with ESI TF and PLDD in patients with lumbar radicular pain caused by intervertebral disc herniation
Status
Recruiting
Last Updated
3 years ago

Overview

Brief Summary

The most common cause of lumbar radicular pain is intervertebral disc herniation with or without pressure on the nerve root, which leads to inflammation and pain. Just as the mechanical component is important, so is the inflammatory component in the etiology of lumbar radicular pain. Numerous pro-inflammatory and anti-inflammatory proteins were found in serum, cerebrospinal fluid and disc biopsies from patients with lumbar radicular pain. Interleukin(IL)-1β, IL-6, IL-8, and tumor necrosis factor TNF-α are the most frequently investigated (8, 9).

Elevated levels of IL-6 and TNF-α were found in patients with lumbar pain caused by intervertebral disc herniation.

In order to avoid systemic and unwanted effects of analgesics, undergoing anesthesia and long-term and extensive operations, minimally invasive procedures are increasingly used in the treatment of lumbar radicular pain. Epidural administration of steroids and local anesthetic through a transforaminal approach (ESI TF) and percutaneous laser disc decompression (PLDD) are some of these methods.

Lumbar radicular pain occurs due to inflammation and/or disc-radicular contact. Corticosteroids interrupt the inflammatory process, the transmission of pain signals via nociceptive C fibers and reduce capillary permeability. Along with the corticosteroid, a local anesthetic is also applied, which leads to immediate analgesia by blocking the conduction of painful impulses by blocking sodium channels. Percutaneous laser disc decompression (PLDD) is a minimally invasive method of treating lumbar radicular pain performed under local anesthesia under fluoroscopic control. The laser energy leads to the heating of the tissue of the nucleus pulposus, which leads to the evaporation of a small volume of water inside the disc. Viewing the disc as a closed hydraulic system, a small decrease in the water content within the disc leads to a disproportionate decrease in intradiscal pressure, which results in retraction of the herniated disc. Thermal energy leads to protein denaturation, which causes structural changes and thus prevents further retention of water in the disc, and a stable scar is created at the point of laser action. On the basis of current knowledge, an attempt is made to establish a link between inflammatory parameters as predictive and prognostic biomarkers in the treatment of patients with lumbar radicular pain caused by intervertebral disc herniation.

Detailed Description

The hypothesis is that: * there will be no difference in effectiveness in reducing the intensity of pain, improving the quality of life, reducing the degree of disability, reducing neuropathic pain, reducing anxiety and depression, and improving the quality of sleep in the treatment of lumbar radicular pain caused by disc herniation without discoradicular contact, but PLDD will be more effective in patients where there is discorradicular contact * PLDD will lead to a greater reduction in serum levels of inflammatory markers in patients with nerve compression by intervertebral disc herniation * ESI TF will lead to a greater reduced serum level of inflammatory markers where there is no nerve compression by intervertebral disc herniation * The group of patients in whom PLDD was performed will have a significantly greater retraction of the disc herniation compared to ESI TF

Registry
clinicaltrials.gov
Start Date
November 30, 2021
End Date
July 30, 2024
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Osijek University Hospital
Responsible Party
Principal Investigator
Principal Investigator

Dino Budrovac

MD, Specialist in anesthesiology, resuscitation and intensive care medicine

Osijek University Hospital

Eligibility Criteria

Inclusion Criteria

  • Age between 18 and 60
  • Signing informed consent
  • Unilateral lumbar radicular pain
  • Subjects who do not responds to conservative treatment
  • Disc herniation at one level
  • MR verified disc herniation
  • Pain intensity measured by VAS scale, from 0 - 10, \>5

Exclusion Criteria

  • Subjects younger than 18 and older than 65 years
  • Refusal of the subjects to participate in the research
  • Central stenosis of the lumbar canal
  • Lumbar radicular pain caused by causes other than intervertebral disc herniation
  • Pregnancy
  • Allergy to steroids, local anesthetics, fentanyl, midazolam and contrast medium
  • Positive history of prolonged bleeding
  • Local or systemic infection
  • Previous lumbar spine surgery7
  • Opioid abuse

Outcomes

Primary Outcomes

Compare the effectiveness in reducing pain intensity with ESI TF and PLDD in patients with lumbar radicular pain caused by intervertebral disc herniation

Time Frame: Six months

Compare the effectiveness in reducing pain intensity with epidural administration of steroids and local anesthetic through a transforaminal approach (ESI TF) and percutaneous laser disc decompression (PLDD) in patients with lumbar radicular pain caused by intervertebral disc herniation, measured by the VAS scale (0-10). The severity of pain was assessed using the visual-analog scale of pain (VAS). The scale consists of a solid line that is 0 to 10 numbered at both its beginning and conclusion. The number 0, which denotes the lack of pain, is located on the far left, while the number 10, which denotes unbearable pain, is located on the far right.

Investigate the difference imeasured with a visual analogue scale between ESI TF and PLDD in herniated intervertebral disc with and without discoradicular contact

Time Frame: Six months

Investigate the difference measured with a visual analogue scale between ESI TF and PLDD in herniated intervertebral disc with and without discoradicular contact. The severity of pain was assessed using the visual-analog scale of pain (VAS). The scale consists of a solid line that is 0 to 10 numbered at both its beginning and conclusion. The number 0, which denotes the lack of pain, is located on the far left, while the number 10, which denotes unbearable pain, is located on the far right.

Secondary Outcomes

  • Investigate the influence of PLDD and ESI TF on the retraction of disc herniation(Six months)
  • Investigate the impact of PLDD and ESI TF in the treatment of lumbar radicular pain caused by disc herniation on quality of life(Six months)
  • Investigate the impact of PLDD and ESI TF in the treatment of lumbar radicular pain caused by disc herniation on neuropathic pain(Six months)
  • Investigate the impact of PLDD and ESI TF in the treatment of lumbar radicular pain caused by disc herniation on degree of anxiety and depression(Six months)
  • Investigate the influence of ESI TF and PLDD on the serum level of interleukin-6 (IL-6)(Six months)
  • Investigate the impact of PLDD and ESI TF in the treatment of lumbar radicular pain caused by disc herniation on quality of sleep(Six months)
  • Investigate the impact of PLDD and ESI TF in the treatment of lumbar radicular pain caused by disc herniation on degree of disability(Six months)

Study Sites (1)

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