High-voltage pulsed radiofrequency treatment for chronic lower back pain
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
This study is testing if a new high-voltage pulsed radiofrequency treatment can help people with chronic lower back pain feel better compared to the standard treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 98 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Consorci Sanitari de Terrassa Academic / other |
| Locations | 1 site (Terrassa, Barcelona) |
| Trial ID | NCT06264297 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of high-voltage pulsed radiofrequency (PRF) on patients suffering from chronic lumbar radicular and neuropathic pain. It is a prospective, double-blinded, and randomized controlled trial designed to compare the outcomes of high-voltage PRF against standard PRF. Participants will be carefully selected based on specific inclusion criteria, including the presence of unilateral pain and confirmation of symptoms through MRI and EMG. The goal is to determine if high-voltage PRF can provide better pain relief and functional improvement for these patients.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old with unilateral pain radiating to the lower extremity and a confirmed diagnosis of radicular syndrome lasting three months or more.
Not a fit: Patients with non-radicular low back pain or those with peripheral neuropathy of the lower extremities may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve pain management for patients with chronic lumbar radicular and neuropathic pain.
How similar studies have performed: While pulsed radiofrequency has been explored in pain management, the specific approach of high-voltage PRF is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Terrassa, Barcelona
- Consorci Sanitari de Terrassa — Terrassa, Barcelona, Spain (Recruiting)
Study contacts
- Study coordinator: Maria Martinez
- Email: mariamartinezgarcia@gmail.com
- Phone: +34650528215
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.