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

Osijek University Hospital

Status: Enrolling

Conditions: Herniated Disc; Low Back Pain

Treatments: Procedure: Percutaneous Laser Disc Decompression; Procedure: Epidural Steroid Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT05601791

2158-61-07-20-05

Details and patient eligibility

About

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.

Full 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

Enrollment: 116 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

116 participants in 4 patient groups

Discoradicular contact+ESI TF

Active Comparator group

Description:

Patients with discorradicular contact who underwent ESI TF

Treatment:

Procedure: Epidural Steroid Injection

Discoradicular contact+PLDD

Active Comparator group

Description:

Patients with discorradicular contact who underwent PLDD

Treatment:

Procedure: Percutaneous Laser Disc Decompression

Without discoradicular contact+ESI TF

Active Comparator group

Description:

Patients without discorradicular contact who underwent ESI TF

Treatment:

Procedure: Epidural Steroid Injection

Without discoradicular contact+PLDD

Active Comparator group

Description:

Patients without discorradicular contact who underwent PLDD

Treatment:

Procedure: Percutaneous Laser Disc Decompression