NCT06264297

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
98

participants targeted

Target at P50-P75 for not_applicable

Timeline
19mo left

Started Feb 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress67%
Feb 2023Dec 2027

Study Start

First participant enrolled

February 20, 2023

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

February 12, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 16, 2024

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

February 16, 2024

Status Verified

February 1, 2024

Enrollment Period

3.9 years

First QC Date

February 12, 2024

Last Update Submit

February 12, 2024

Conditions

Pulsed RadiofrequencyLumbar Radiculopathy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • DN4 - QUESTIONNAIRE

    From enrollment to the end of treatment at 6 months

  • Visual Numeric Scale

    From enrollment to the end of treatment at 6 months

  • Categorical scale

    From enrollment to the end of treatment at 6 months

  • patient global impression of improvement (pgi-i) score

    From enrollment to the end of treatment at 6 months

Study Arms (2)

GROUP I

ACTIVE COMPARATOR

RFP on the affected level or levels will be carried out during three cycles of 120 s, limited to a temperature of 42° and a voltage of 45V

Procedure: Radiofrequency

GROUP II

EXPERIMENTAL

RFP on the affected level or levels will be carried out during three cycles of 120 s, limited to a temperature of 42° and a voltage of 65V

Procedure: Radiofrequency

Interventions

RadiofrequencyPROCEDURE

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.

GROUP IGROUP II

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Consorci Sanitari de Terrassa

Terrassa, Barcelona, 08227, Spain

RECRUITING

Related Publications (12)

  • 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: 19761513BACKGROUND

  • 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: 28540817BACKGROUND

  • 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: 16336478BACKGROUND

  • 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: 34992451BACKGROUND

  • 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: 17305674BACKGROUND

  • 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: 24553305BACKGROUND

  • 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: 31577546BACKGROUND

  • 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: 21812907BACKGROUND

  • 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.

    PMID: 34671961BACKGROUND

  • 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.

    PMID: 32488240BACKGROUND

  • 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.

    PMID: 31538405BACKGROUND

  • 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.

    PMID: 31973587BACKGROUND

MeSH Terms

Conditions

Radiculopathy

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System Diseases

Central Study Contacts

Maria Martinez

CONTACT

+34650528215mariamartinezgarcia@gmail.com

Maria Martinez

CONTACT

650528215mariamartinezgarcia@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anesthesiologist

Study Record Dates

First Submitted

February 12, 2024

First Posted

February 16, 2024

Study Start

February 20, 2023

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

February 16, 2024

Record last verified: 2024-02

Locations

ES(1)