NCT06264297 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
| NCT ID | NCT06264297 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Consorci Sanitari de Terrassa |
| Condition | Pulsed Radiofrequency |
| Study Type | INTERVENTIONAL |
| Enrollment | 98 participants |
| Start Date | 2023-02-20 |
| Primary Completion | 2027-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 98 participants in total. It began in 2023-02-20 with a primary completion date of 2027-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06264297 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pulsed Radiofrequency. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06264297 currently recruiting?
Yes, NCT06264297 is actively recruiting participants. Contact the research team at mariamartinezgarcia@gmail.com for enrollment information.
Where is the NCT06264297 trial being conducted?
This trial is being conducted at Terrassa, Spain.
Who is sponsoring the NCT06264297 clinical trial?
NCT06264297 is sponsored by Consorci Sanitari de Terrassa. The trial plans to enroll 98 participants.