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

Lumbar Radiculopathy Clinical Trial

— Radiofrequency  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06264297
• Other study ID #: 01-22-270-111
• Status: Recruiting
• Phase: N/A
• Start date: February 20, 2023
• Est. completion date: December 2027

Study information

• Verified date: February 2024
• Source: Consorci Sanitari de Terrassa
• Contact: Maria Martinez
• Phone: +34650528215
• Email: mariamartinezgarcia[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 98
• Est. completion date: December 2027
• Est. primary completion date: January 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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'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.

Related Conditions & MeSH terms

• Lumbar Radiculopathy
• Neuralgia
• Pulsed Radiofrequency
• Radiculopathy

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Spain	Consorci Sanitari de Terrassa	Terrassa	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Consorci Sanitari de Terrassa

Country where clinical trial is conducted

Spain, 

References & Publications (12)

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. — View 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. — View 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. — View 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. Erratum In: Pain Pract. 2010 May-Jun;10(3):264. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	OSWESTRY LOW BACK DISABILITY QUESTIONNAIRE	this questionnaire has been designed to give us information as to how your back pain has affected your ability to manage everyday life	From enrollment to the end of treatment at 6 months
Secondary	DN4 - QUESTIONNAIRE	DN4 - QUESTIONNAIRE To estimate the probability of neuropathic pain, please answer yes or no for each item of the following four questions.	From enrollment to the end of treatment at 6 months
Secondary	Visual Numeric Scale	ranging from 0 to 10 was used to measure pain intensity	From enrollment to the end of treatment at 6 months
Secondary	Categorical scale	uses adjectives, such as "mild," "moderate," "severe," and excruciating," to describe pain levels.	From enrollment to the end of treatment at 6 months
Secondary	patient global impression of improvement (pgi-i) score	is a transition scale that is a single question asking the patient to rate their urinary tract condition now, as compared with how it was prior to before beginning treatment	From enrollment to the end of treatment at 6 months