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Efficacy of PLDD Versus ESI in the Treatment of Lumbar Radicular Pain

NCT05601791 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 116

Last updated 2022-11-03

No results posted yet for this study

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.

Conditions

  • Herniated Disc
  • Low Back Pain

Interventions

PROCEDURE

Epidural Steroid Injection

Epidural Steroid Injection transforaminal approach Drug: midazolam, fentanyl, lidocaine, levobupivacaine, methilprednisoloneacetat

PROCEDURE

Percutaneous Laser Disc Decompression

Percutaneous Laser Disc Decompression Drug: midazolam, fentanyl, lidocaine

Sponsors & Collaborators

  • Osijek University Hospital

    lead OTHER

Principal Investigators

  • Dino Budrovac, MD · UH Osijek

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-30
Primary Completion
2023-12-30
Completion
2024-07-30

Countries

  • Croatia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05601791 on ClinicalTrials.gov