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

NCT05601791 | Unknown

• 1 other identifier: 2158-61-07-20-05
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

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.

Conditions

Herniated Disc; Low Back Pain

Keywords

herniated disc; epidural injection; laser; low back pain; radiculopathy

Outcome Measures

Primary Outcomes (2)

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

  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.

  Six months

• Investigate the difference imeasured with a visual analogue scale between ESI TF and PLDD in herniated intervertebral disc with and without discoradicular contact

  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.

  Six months

Secondary Outcomes (7)

• Investigate the influence of ESI TF and PLDD on the serum level of interleukin-6 (IL-6)

  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

  Six months

• Investigate the influence of PLDD and ESI TF on the retraction of disc herniation

  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

  Six months

• Investigate the impact of PLDD and ESI TF in the treatment of lumbar radicular pain caused by disc herniation on neuropathic pain

  Six months

Study Arms (4)

Discoradicular contact+ESI TF

ACTIVE COMPARATOR

Patients with discorradicular contact who underwent ESI TF

Procedure: Epidural Steroid Injection

Discoradicular contact+PLDD

ACTIVE COMPARATOR

Patients with discorradicular contact who underwent PLDD

Procedure: Percutaneous Laser Disc Decompression

Without discoradicular contact+ESI TF

ACTIVE COMPARATOR

Patients without discorradicular contact who underwent ESI TF

Procedure: Epidural Steroid Injection

Without discoradicular contact+PLDD

ACTIVE COMPARATOR

Patients without discorradicular contact who underwent PLDD

Procedure: Percutaneous Laser Disc Decompression

Interventions

Epidural Steroid Injection PROCEDURE

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

Discoradicular contact+ESI TF; Without discoradicular contact+ESI TF

Percutaneous Laser Disc Decompression PROCEDURE

Percutaneous Laser Disc Decompression Drug: midazolam, fentanyl, lidocaine

Discoradicular contact+PLDD; Without discoradicular contact+PLDD

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Osijek University Hospital: lead

Study Sites (1)

UH Osijek

Osijek, 31000, Croatia

RECRUITING

Related Publications (13)

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  PMID: 24665116 BACKGROUND

• Khan AN, Jacobsen HE, Khan J, Filippi CG, Levine M, Lehman RA Jr, Riew KD, Lenke LG, Chahine NO. Inflammatory biomarkers of low back pain and disc degeneration: a review. Ann N Y Acad Sci. 2017 Dec;1410(1):68-84. doi: 10.1111/nyas.13551.

  PMID: 29265416 BACKGROUND

• Porchet F, Wietlisbach V, Burnand B, Daeppen K, Villemure JG, Vader JP. Relationship between severity of lumbar disc disease and disability scores in sciatica patients. Neurosurgery. 2002 Jun;50(6):1253-9; discussion 1259-60. doi: 10.1097/00006123-200206000-00014.

  PMID: 12015843 BACKGROUND

• el Barzouhi A, Vleggeert-Lankamp CL, Lycklama a Nijeholt GJ, Van der Kallen BF, van den Hout WB, Jacobs WC, Koes BW, Peul WC; Leiden-The Hague Spine Intervention Prognostic Study Group. Magnetic resonance imaging in follow-up assessment of sciatica. N Engl J Med. 2013 Mar 14;368(11):999-1007. doi: 10.1056/NEJMoa1209250.

  PMID: 23484826 BACKGROUND

• Wuertz K, Haglund L. Inflammatory mediators in intervertebral disk degeneration and discogenic pain. Global Spine J. 2013 Jun;3(3):175-84. doi: 10.1055/s-0033-1347299. Epub 2013 May 21.

  PMID: 24436868 BACKGROUND

• Jungen MJ, Ter Meulen BC, van Osch T, Weinstein HC, Ostelo RWJG. Inflammatory biomarkers in patients with sciatica: a systematic review. BMC Musculoskelet Disord. 2019 Apr 9;20(1):156. doi: 10.1186/s12891-019-2541-0.

  PMID: 30967132 BACKGROUND

• Kraychete DC, Sakata RK, Issy AM, Bacellar O, Santos-Jesus R, Carvalho EM. Serum cytokine levels in patients with chronic low back pain due to herniated disc: analytical cross-sectional study. Sao Paulo Med J. 2010;128(5):259-62. doi: 10.1590/s1516-31802010000500003.

  PMID: 21181064 BACKGROUND

• Patel VB, Wasserman R, Imani F. Interventional Therapies for Chronic Low Back Pain: A Focused Review (Efficacy and Outcomes). Anesth Pain Med. 2015 Aug 22;5(4):e29716. doi: 10.5812/aapm.29716. eCollection 2015 Aug.

  PMID: 26484298 BACKGROUND

• Harris JD. Management of expected and unexpected opioid-related side effects. Clin J Pain. 2008 May;24 Suppl 10:S8-S13. doi: 10.1097/AJP.0b013e31816b58eb.

  PMID: 18418226 BACKGROUND

• Momenzadeh S, Koosha A, Kazempoor Monfared M, Bairami J, Zali A, Ommi D, Hosseini B, Hashemi M, Sayadi S, Aryani R, Nematollahi F, Nematollahi L, Barati M. The Effect of Percutaneous Laser Disc Decompression on Reducing Pain and Disability in Patients With Lumbar Disc Herniation. J Lasers Med Sci. 2019 Winter;10(1):29-32. doi: 10.15171/jlms.2019.04. Epub 2018 Dec 15.

  PMID: 31360365 BACKGROUND

• Schneider B, Zheng P, Mattie R, Kennedy DJ. Safety of epidural steroid injections. Expert Opin Drug Saf. 2016 Aug;15(8):1031-9. doi: 10.1080/14740338.2016.1184246. Epub 2016 May 13.

  PMID: 27148630 BACKGROUND

• Choy DS. Percutaneous laser disc decompression. J Clin Laser Med Surg. 1995 Jun;13(3):125-6. doi: 10.1089/clm.1995.13.125.

  PMID: 10150634 BACKGROUND

• Budrovac D, Rados I, Hnatesen D, Harsanji-Drenjancevic I, Tot OK, Katic F, Lukic I, Skiljic S, Neskovic N, Dimitrijevic I. Effectiveness of Epidural Steroid Injection Depending on Discoradicular Contact: A Prospective Randomized Trial. Int J Environ Res Public Health. 2023 Feb 19;20(4):3672. doi: 10.3390/ijerph20043672.

  PMID: 36834367 DERIVED

MeSH Terms

Conditions

Intervertebral Disc Displacement; Low Back Pain; Radiculopathy

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Dino Budrovac, MD

  UH Osijek

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dino Budrovac, MD

CONTACT

+385995162489; dino.budrovac@gmail.com

Ivan Radoš, Prof.MD.PhD

CONTACT

+385917974306; irados11@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Specialist in anesthesiology, resuscitation and intensive care medicine

Model Details: 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.

Study Record Dates

• First Submitted: October 12, 2022
• First Posted: November 1, 2022
• Study Start: November 30, 2021
• Primary Completion: December 30, 2023
• Study Completion: July 30, 2024
• Last Updated: November 3, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1)