High-Voltage Pulsed Radiofrequency of the Lumbar Dorsal Root Ganglion for the Treatment of Chronic Lumbar Radicular and Neuropathic Pain; A Prospective, Doble-blinded and Randomized Controlled Trial

Обзор

The management of chronic lumbar radicular and neuropathic pain is complex and the treatment success rates are low. Pulsed radiofrequency (PRF) has been described in these cases. In order to determine whether high-voltage PRF show better results than PRF a prospective, doble-blinded and randomized study is conducted in patients with chronic lumbar radicular and neuropathic pain.

Вмешательства

• Процедура Radiofrequency
  Pulsed radiofrequency (PRF) is a nonablative pain treatment that uses radiofrequency current in short high-voltage bursts, resulting in interruption of nociceptive afferent pathways. This study aims to show how the variation in radiofrequency voltage applied to the dorsal root ganglion (DRG) affects the treatment of neuropathic pain.

Первичные конечные точки

• OSWESTRY LOW BACK DISABILITY QUESTIONNAIRE [Срок оценки: From enrollment to the end of treatment at 6 months]

Вторичные конечные точки (4)

• DN4 - QUESTIONNAIRE [Срок оценки: From enrollment to the end of treatment at 6 months]
• Visual Numeric Scale [Срок оценки: From enrollment to the end of treatment at 6 months]
• Categorical scale [Срок оценки: From enrollment to the end of treatment at 6 months]
• patient global impression of improvement (pgi-i) score [Срок оценки: From enrollment to the end of treatment at 6 months]

Критерии участия

Критерии включения

• Patients over 18 years of age.
• Unilateral pain radiating to the lower extremity (with or without lumbar pain), which clinically corresponds to the path of the corresponding dermatomes.
• Correlation between clinical symptoms and lesion observed by magnetic resonance imaging (MRI).
• Radicular syndrome of three months or more of evolution.
• Normal or pathological electromyogram (EMG).
• Pain with neuropathic characteristics confirmed by the DN4 neuropathic pain questionnaire.
• Patients with a previous positive block diagnosis.
• Patients who have signed the informed consent document.

Критерии исключения

• Patients under 18 years of age.
• Patients with non-radicular low back pain.
• MRI not consistent with the patient\'s symptoms.
• Patients with peripheral neuropathy of the lower extremities.
• Patients with a history or current diagnosis of serious mental disorder.
• Patients with moderate or severe cognitive impairment, or evidence of acute or subacute confusional syndrome.
• Infection at the puncture site.
• Coagulation disorders.
• Pregnant patients.
• Patients who refuse to sign the informed consent document.
• Patients allergic to radiological contrast.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Испания · 1 центр

• Consorci Sanitari de Terrassa — Terrassa

Публикации

• Erdine S, Bilir A, Cosman ER, Cosman ER Jr. Ultrastructural changes in axons following exposure to pulsed radiofrequency fields. Pain Pract. 2009 Nov-Dec;9(6):407-17. doi: 10.1111/j.1533-2500.2009.00317.x. Epub 2009 Sep 15. PMID 19761513
• Ewertowska E, Mercadal B, Munoz V, Ivorra A, Trujillo M, Berjano E. Effect of applied voltage, duration and repetition frequency of RF pulses for pain relief on temperature spikes and electrical field: a computer modelling study. Int J Hyperthermia. 2018 Feb;34(1):112-121. doi: 10.1080/02656736.2017.1323122. Epub 2017 May 16. PMID 28540817
• Cosman ER Jr, Cosman ER Sr. Electric and thermal field effects in tissue around radiofrequency electrodes. Pain Med. 2005 Nov-Dec;6(6):405-24. doi: 10.1111/j.1526-4637.2005.00076.x. PMID 16336478
• Russo M, Santarelli D, Wright R, Gilligan C. A History of the Development of Radiofrequency Neurotomy. J Pain Res. 2021 Dec 24;14:3897-3907. doi: 10.2147/JPR.S334862. eCollection 2021. PMID 34992451
• Abejon D, Garcia-del-Valle S, Fuentes ML, Gomez-Arnau JI, Reig E, van Zundert J. Pulsed radiofrequency in lumbar radicular pain: clinical effects in various etiological groups. Pain Pract. 2007 Mar;7(1):21-6. doi: 10.1111/j.1533-2500.2007.00105.x. PMID 17305674
• Van Boxem K, Huntoon M, Van Zundert J, Patijn J, van Kleef M, Joosten EA. Pulsed radiofrequency: a review of the basic science as applied to the pathophysiology of radicular pain: a call for clinical translation. Reg Anesth Pain Med. 2014 Mar-Apr;39(2):149-59. doi: 10.1097/AAP.0000000000000063. PMID 24553305
• Vigneri S, Sindaco G, La Grua M, Zanella M, Lo Bianco G, Paci V, Vinci FM, Sciacca C, Ravaioli L, Pari G. Electrocatheter-mediated High-voltage Pulsed Radiofrequency of the Dorsal Root Ganglion in the Treatment of Chronic Lumbosacral Neuropathic Pain: A Randomized Controlled Study. Clin J Pain. 2020 Jan;36(1):25-33. doi: 10.1097/AJP.0000000000000766. PMID 31577546
• Van Boxem K, van Bilsen J, de Meij N, Herrler A, Kessels F, Van Zundert J, van Kleef M. Pulsed radiofrequency treatment adjacent to the lumbar dorsal root ganglion for the management of lumbosacral radicular syndrome: a clinical audit. Pain Med. 2011 Sep;12(9):1322-30. doi: 10.1111/j.1526-4637.2011.01202.x. Epub 2011 Aug 3. PMID 21812907

Идентификаторы

NCT: NCT06264297 · 01-22-270-111

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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