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

Consorci Sanitari de Terrassa

Status: Enrolling

Conditions: Pulsed Radiofrequency; Lumbar Radiculopathy

Treatments: Procedure: Radiofrequency

Study type: Interventional

Funder types: Other

Identifiers

NCT06264297

01-22-270-111

Details and patient eligibility

About

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.

Enrollment: 98 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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98 participants in 2 patient groups

GROUP I

Active Comparator group

Description:

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

Treatment:

Procedure: Radiofrequency

GROUP II

Experimental group

Description:

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

Treatment:

Procedure: Radiofrequency