Clinical trial NCT05601791: Efficacy of PLDD Versus ESI in the Treatment of Lumbar Radicular Pain
Official title: Efficacy of Percutaneous Laser Disc Decompression Versus Epidural Steroid and Local Anesthetic Injection by Transforaminal Approach in the Treatment of Lumbar Radicular Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Herniated Disc
Low Back Pain
Keywords: herniated disc
epidural injection
laser
low back pain
radiculopathy
Lead sponsor: Osijek University Hospital
Sponsor class: OTHER
First posted: 2022-11-01
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The research is designed as a randomized controlled trial, and will be conducted at the Clinic for Anesthesiology, Reanimatology and Intensive Medicine in the Department of Pain Management of the Osijek Clinical Hospital Center after obtaining the approval of the Ethics Committee. All patients will receive a written informed consent in which the procedure to be performed will be described, and the procedure will also be explained to them orally. After signing the informed consent, the patients will be divided into 2 groups using a random number generator, depending on whether there is discorradicular contact or not, and then according to the treatment method (ESI TF or PLDD). All subjects will be selected at the Institute for Pain Management of KBC Osijek.
Primary purpose: TREATMENT

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

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
* Proven inflammatory rheumatic disease and inflammatory bowel disease in the active phase
* Other acute infections

Primary outcomes:
measure: Compare the effectiveness in reducing pain intensity with ESI TF and PLDD in patients with lumbar radicular pain caused by intervertebral disc herniation
timeFrame: Six months
measure: Investigate the difference imeasured with a visual analogue scale between ESI TF and PLDD in herniated intervertebral disc with and without discoradicular contact
timeFrame: Six months
Secondary outcomes:
measure: Investigate the influence of ESI TF and PLDD on the serum level of interleukin-6 (IL-6)
timeFrame: Six months
measure: Investigate the impact of PLDD and ESI TF in the treatment of lumbar radicular pain caused by disc herniation on quality of life
timeFrame: Six months
measure: Investigate the influence of PLDD and ESI TF on the retraction of disc herniation
timeFrame: Six months
measure: Investigate the impact of PLDD and ESI TF in the treatment of lumbar radicular pain caused by disc herniation on degree of disability
timeFrame: Six months
measure: Investigate the impact of PLDD and ESI TF in the treatment of lumbar radicular pain caused by disc herniation on neuropathic pain
timeFrame: Six months
measure: 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
timeFrame: Six months
measure: Investigate the impact of PLDD and ESI TF in the treatment of lumbar radicular pain caused by disc herniation on quality of sleep
timeFrame: Six months
Other outcomes:
Locations:
city: Osijek
country: Croatia
facility: UH Osijek
Study officials:
affiliation: UH Osijek
name: Dino Budrovac, MD
role: PRINCIPAL_INVESTIGATOR
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