Efficacy of PLDD Versus ESI in the Treatment of Lumbar Radicular Pain
NCT ID: NCT05601791
Last Updated: 2022-11-03
Study Results
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Basic Information
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UNKNOWN
NA
116 participants
INTERVENTIONAL
2021-11-30
2024-07-30
Brief Summary
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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.
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Detailed Description
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* 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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Discoradicular contact+ESI TF
Patients with discorradicular contact who underwent ESI TF
Epidural Steroid Injection
Epidural Steroid Injection transforaminal approach Drug: midazolam, fentanyl, lidocaine, levobupivacaine, methilprednisoloneacetat
Discoradicular contact+PLDD
Patients with discorradicular contact who underwent PLDD
Percutaneous Laser Disc Decompression
Percutaneous Laser Disc Decompression Drug: midazolam, fentanyl, lidocaine
Without discoradicular contact+ESI TF
Patients without discorradicular contact who underwent ESI TF
Epidural Steroid Injection
Epidural Steroid Injection transforaminal approach Drug: midazolam, fentanyl, lidocaine, levobupivacaine, methilprednisoloneacetat
Without discoradicular contact+PLDD
Patients without discorradicular contact who underwent PLDD
Percutaneous Laser Disc Decompression
Percutaneous Laser Disc Decompression Drug: midazolam, fentanyl, lidocaine
Interventions
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Epidural Steroid Injection
Epidural Steroid Injection transforaminal approach Drug: midazolam, fentanyl, lidocaine, levobupivacaine, methilprednisoloneacetat
Percutaneous Laser Disc Decompression
Percutaneous Laser Disc Decompression Drug: midazolam, fentanyl, lidocaine
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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Osijek University Hospital
OTHER
Responsible Party
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Dino Budrovac
MD, Specialist in anesthesiology, resuscitation and intensive care medicine
Principal Investigators
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Dino Budrovac, MD
Role: PRINCIPAL_INVESTIGATOR
UH Osijek
Locations
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UH Osijek
Osijek, , Croatia
Countries
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Central Contacts
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Facility Contacts
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References
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Hoy D, March L, Brooks P, Blyth F, Woolf A, Bain C, Williams G, Smith E, Vos T, Barendregt J, Murray C, Burstein R, Buchbinder R. The global burden of low back pain: estimates from the Global Burden of Disease 2010 study. Ann Rheum Dis. 2014 Jun;73(6):968-74. doi: 10.1136/annrheumdis-2013-204428. Epub 2014 Mar 24.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Choy DS. Percutaneous laser disc decompression. J Clin Laser Med Surg. 1995 Jun;13(3):125-6. doi: 10.1089/clm.1995.13.125.
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.
Provided Documents
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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Other Identifiers
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2158-61-07-20-05
Identifier Type: -
Identifier Source: org_study_id
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