drugset / Trial / NCT07303309
Effectiveness of High-Voltage PRF for Chronic Lumbosacral Radicular Pain
Completed
22 enrolled
Hasanuddin University
Faculty of Medicine, Gadjah Mada University · collabSardjito General Hospital, Yogyakarta, Indonesia · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This randomized controlled trial compared high-voltage (60 V) and low-voltage (45 V) pulsed radiofrequency (PRF) for treating chronic lumbosacral radicular pain in adult patients. The study evaluated differences in pain reduction (using the Visual Analogue Scale \[VAS\] and Numeric Rating Scale \[NRS-11\]), functional ability (using Oswestry Disability Index scores), serum Interleukin-6 levels, and overall safety. All participants received fluoroscopy-guided PRF at 42°C for three 120-second cycles and were followed for approximately 6 weeks.
Timeline
- Start
- 2025-02-07
- Primary completion
- 2025-04-29
- Completion
- 2025-04-29
Publications
- Background Deyo RA, Mirza SK. CLINICAL PRACTICE. Herniated Lumbar Intervertebral Disk. N Engl J Med. 2016 May 5;374(18):1763-72. doi: 10.1056/NEJMcp1512658. No abstract available.
- Background Jang JN, Park S, Park JH, Song Y, Kim YU, Kim DS, Sohn JE, Park S. Output Current and Efficacy of Pulsed Radiofrequency of the Lumbar Dorsal Root Ganglion in Patients With Lumbar Radiculopathy: A Prospective, Double-blind, Randomized Pilot Study. Pain Physician. 2023 Nov;26(7):E797-E804.
- Background Erken B, Edipoglu IS. Efficacy of High-Voltage Pulsed Radiofrequency of the Dorsal Root Ganglion for Treatment of Chronic Lumbosacral Radicular Pain: A Randomized Clinical Trial. Neuromodulation. 2024 Jan;27(1):135-140. doi: 10.1016/j.neurom.2022.10.056. Epub 2022 Dec 1.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Background | Fentanyl | Other / unclassified | 0.5 ug/kg | Intravenous |
| Background | Fentanyl | Other / unclassified | 1 ug/kg | Intravenous |