Clinical trial NCT06264297: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pulsed Radiofrequency
Lumbar Radiculopathy
Lead sponsor: Consorci Sanitari de Terrassa
Sponsor class: OTHER
First posted: 2024-02-16
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Patients under 18 years of age.
* Patients with non-radicular low back pain.
* MRI not consistent with the patient\&#39;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.

Primary outcomes:
measure: OSWESTRY LOW BACK DISABILITY QUESTIONNAIRE
timeFrame: From enrollment to the end of treatment at 6 months
Secondary outcomes:
measure: DN4 - QUESTIONNAIRE
timeFrame: From enrollment to the end of treatment at 6 months
measure: Visual Numeric Scale
timeFrame: From enrollment to the end of treatment at 6 months
measure: Categorical scale
timeFrame: From enrollment to the end of treatment at 6 months
measure: patient global impression of improvement (pgi-i) score
timeFrame: From enrollment to the end of treatment at 6 months
Other outcomes:
Locations:
city: Terrassa
country: Spain
facility: Consorci Sanitari de Terrassa
state: Barcelona
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Karakose Caliskan D, Akesen S, Turker YG, Gurbet A. The effect of combined pulsed radiofrequency treatment to dorsal root ganglion with transforaminal epidural steroid injection on pain. Agri. 2021 Oct;33(4):223-231. doi: 10.14744/agri.2021.94824.
citation: Vuka I, Marcius T, Dosenovic S, Ferhatovic Hamzic L, Vucic K, Sapunar D, Puljak L. Efficacy and Safety of Pulsed Radiofrequency as a Method of Dorsal Root Ganglia Stimulation in Patients with Neuropathic Pain: A Systematic Review. Pain Med. 2020 Dec 25;21(12):3320-3343. doi: 10.1093/pm/pnaa141.
citation: De M, Mohan VK, Bhoi D, Talawar P, Kumar A, Garg B, Trikha A, Dehran M, Kashyap L, Shende DR. Transforaminal Epidural Injection of Local Anesthetic and Dorsal Root Ganglion Pulsed Radiofrequency Treatment in Lumbar Radicular Pain: A Randomized, Triple-Blind, Active-Control Trial. Pain Pract. 2020 Feb;20(2):154-167. doi: 10.1111/papr.12840. Epub 2019 Oct 21.
citation: Napoli A, Alfieri G, Scipione R, Andrani F, Leonardi A, Catalano C. Pulsed radiofrequency for low-back pain and sciatica. Expert Rev Med Devices. 2020 Feb;17(2):83-86. doi: 10.1080/17434440.2020.1719828. Epub 2020 Jan 23. No abstract available.