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Recruiting NCT05601791

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

Conditions: Herniated Disc, Low Back Pain

Sex: All
Ages: 18 Years – 65 Years
Phase: NA
Enrollment: 116
Sponsor: Osijek University Hospital

Location: Croatia

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.

Eligibility Criteria

Inclusion Criteria:Age between 18 and 60Signing informed consentUnilateral lumbar radicular painSubjects who do not responds to conservative treatmentDisc herniation at one levelMR verified disc herniationPain intensity measured by VAS scale, from 0 - 10, >5Exclusion Criteria:Subjects younger than 18 and older than 65 yearsRefusal of the subjects to participate in the researchCentral stenosis of the lumbar canalLumbar radicular pain caused by causes other than intervertebral disc herniationPregnancyAllergy to steroids, local anesthetics, fentanyl, midazolam and contrast mediumPositive history of prolonged bleedingLocal or systemic infectionPrevious lumbar spine surgery7Opioid abuseProven inflammatory rheumatic disease and inflammatory bowel disease in the active phaseOther acute infections

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05601791). StuddyBuddy aggregates publicly available trial information.