RecruitingNot ApplicableNCT06264297

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


Sponsor

Consorci Sanitari de Terrassa

Enrollment

98 participants

Start Date

Feb 20, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria8

  • 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 Criteria11

  • 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.

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Interventions

PROCEDURERadiofrequency

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(1)

Consorci Sanitari de Terrassa

Terrassa, Barcelona, Spain

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NCT06264297


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