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

Sponsor

Osijek University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05601791

Collaborator

(none)

116

Enrollment

Location

Arms

Anticipated Duration (Months)

3.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Herniated Disc Low Back Pain	Procedure: Epidural Steroid Injection Procedure: Percutaneous Laser Disc Decompression	N/A

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

116 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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.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.

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Nov 30, 2021

Anticipated Primary Completion Date :

Dec 30, 2023

Anticipated Study Completion Date :

Jul 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Discoradicular contact+ESI TF Patients with discorradicular contact who underwent ESI TF	Procedure: Epidural Steroid Injection Epidural Steroid Injection transforaminal approach Drug: midazolam, fentanyl, lidocaine, levobupivacaine, methilprednisoloneacetat
Active Comparator: Discoradicular contact+PLDD Patients with discorradicular contact who underwent PLDD	Procedure: Percutaneous Laser Disc Decompression Percutaneous Laser Disc Decompression Drug: midazolam, fentanyl, lidocaine
Active Comparator: Without discoradicular contact+ESI TF Patients without discorradicular contact who underwent ESI TF	Procedure: Epidural Steroid Injection Epidural Steroid Injection transforaminal approach Drug: midazolam, fentanyl, lidocaine, levobupivacaine, methilprednisoloneacetat
Active Comparator: Without discoradicular contact+PLDD Patients without discorradicular contact who underwent PLDD	Procedure: Percutaneous Laser Disc Decompression Percutaneous Laser Disc Decompression Drug: midazolam, fentanyl, lidocaine

Outcome Measures

Primary Outcome Measures

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

Investigate the influence of ESI TF and PLDD on the serum level of interleukin-6 (IL-6) [Six months]
Investigate the influence of ESI TF and PLDD on the serum level of interleukin-6 (IL-6)
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 quality of life measured by SF-36 (Short form health survey-36). The Health Status Questionnaire SF-36 was used to examine health status and health-related quality of life. The questionnaire is intended for self-assessment of mental and physical health and social functioning. The SF-36 is a short health status questionnaire consisting of 36 questions. The score is expressed as a standardized value ranging from 0 to 100 for each dimension. Low scores reflect reduced and limited functionality, i.e. loss of function, existence of pain and poor health assessment. High scores reflect the assessment of health as good, without pain and without functional limitations.
Investigate the influence of PLDD and ESI TF on the retraction of disc herniation [Six months]
Investigate the influence of PLDD and ESI TF on the retraction of disc herniation which will be measured by MR control after 6 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]
Investigate the impact of PLDD and ESI TF in the treatment of lumbar radicular pain caused by disc herniation on degree of disability measured by Oswestry Disability Questionnaire Index (ODI). The degree of disability for carrying out everyday activities as a result of low back pain will be evaluated using the Oswestry Disability Index (ODI) questionnaire. The domains of the questionnaire cover aspects of pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sexual function, social life, and traveling, each one containing six statements about section-related activities. The responses are scored on a 0-5 scale. Total score is expressed as the percentage of the maximum score with lower scores indicating lower levels of disability and vice versa.
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 neuropathic pain measured by Pain Detect. The Pain Detect questionnaire is a standardized questionnaire for screening the probability of the existence of a neuropathic pain component in patients with chronic pain. It consists of three parts in sequence from the assessment of the intensity of the pain through the pictorial presentation of the nature of the pain and the main area of the pain to the final questions about the severity of the sensory symptoms which are classified into five groups according to the intensity, from never to very severe.
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 impact of PLDD and ESI TF in the treatment of lumbar radicular pain caused by disc herniation on degree of anxiety and depression measured by the Hospital Anxiety and Depression Scale (HADS). The HADS questionnaire has seven items each for depression and anxiety subscales. Scoring for each item ranges from zero to three, with three denoting highest anxiety or depression level. A total subscale score of >8 points out of a possible 21 denotes considerable symptoms of anxiety or depression.
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 quality of sleep measured by the Pittsburgh Sleep Quality Index (PSQI), consisting of 19 items, each item is weighted on a 0-3 interval scale. The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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