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

Launched by CONSORCI SANITARI DE TERRASSA · Feb 12, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called high-voltage pulsed radiofrequency (PRF) to help people with chronic pain in their lower back and legs, known as lumbar radicular and neuropathic pain. The goal is to find out if this new method is more effective than the standard PRF treatment. The trial is open to both men and women aged 18 and older who have been experiencing pain that travels from their back into their legs for at least three months. To participate, candidates must have certain types of pain that can be connected to changes seen on MRI scans, and they must have had a previous positive diagnosis through a specific pain block test.

Participants in the trial can expect to be randomly assigned to receive either the high-voltage PRF treatment or the standard PRF treatment, and neither they nor the medical team will know which treatment they are getting (this is known as a double-blind study). This helps ensure that the results are fair and unbiased. It's important to note that some individuals may not qualify for this study, particularly those under 18, those with non-radicular pain, or those with certain health conditions like infections or bleeding disorders. If you're interested in participating, you'll need to sign a consent form explaining the study and what it involves.

Gender

ALL

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\'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.