Effectiveness of High-Voltage PRF for Chronic Lumbosacral Radicular Pain
NCT ID: NCT07303309
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
22 participants
INTERVENTIONAL
2025-02-07
2025-04-29
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Standard/Low-Voltage PRF at 45 V
Pulsed Radiofrequency set the voltage at 45 V.
Pulsed Radiofrequency
A specialist performed fluoroscopy-guided monopolar Pulsed Radiofrequency (PRF) on a prone patient using a 22-gauge cannula (Cosman CC, CR type, 10 cm with a 10 mm active tip). Sensory stimulation prior to the procedure was applied at 200 Ohm, 50 Hz (threshold: 0.3 - 0.5 V), and motor stimulation at 2 Hz (threshold: 0.9 - 1.5 V). PRF was applied at a maximum temperature of 42 centigrade, with a frequency of 2 Hz, pulse width of 20 milliseconds, and a duration of 120 seconds per cycle for three cycles. An operating room nurse set the voltage at 45 V or 60 V.
Post-operative Analgesia
Post-procedure analgesia in both groups was provided via IV fentanyl 0.5-1 µg/kg, administered as needed for patients reporting an NRS score greater than 4. This intervention was not a primary focus of the study.
High-Voltage PRF at 60 V
Pulsed Radiofrequency set the voltage at 60 V.
Pulsed Radiofrequency
A specialist performed fluoroscopy-guided monopolar Pulsed Radiofrequency (PRF) on a prone patient using a 22-gauge cannula (Cosman CC, CR type, 10 cm with a 10 mm active tip). Sensory stimulation prior to the procedure was applied at 200 Ohm, 50 Hz (threshold: 0.3 - 0.5 V), and motor stimulation at 2 Hz (threshold: 0.9 - 1.5 V). PRF was applied at a maximum temperature of 42 centigrade, with a frequency of 2 Hz, pulse width of 20 milliseconds, and a duration of 120 seconds per cycle for three cycles. An operating room nurse set the voltage at 45 V or 60 V.
Post-operative Analgesia
Post-procedure analgesia in both groups was provided via IV fentanyl 0.5-1 µg/kg, administered as needed for patients reporting an NRS score greater than 4. This intervention was not a primary focus of the study.
Interventions
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Pulsed Radiofrequency
A specialist performed fluoroscopy-guided monopolar Pulsed Radiofrequency (PRF) on a prone patient using a 22-gauge cannula (Cosman CC, CR type, 10 cm with a 10 mm active tip). Sensory stimulation prior to the procedure was applied at 200 Ohm, 50 Hz (threshold: 0.3 - 0.5 V), and motor stimulation at 2 Hz (threshold: 0.9 - 1.5 V). PRF was applied at a maximum temperature of 42 centigrade, with a frequency of 2 Hz, pulse width of 20 milliseconds, and a duration of 120 seconds per cycle for three cycles. An operating room nurse set the voltage at 45 V or 60 V.
Post-operative Analgesia
Post-procedure analgesia in both groups was provided via IV fentanyl 0.5-1 µg/kg, administered as needed for patients reporting an NRS score greater than 4. This intervention was not a primary focus of the study.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Numeric Rating Scale (NRS-11) ≥ 4 at screening
* Clinical diagnosis of lumbosacral radicular pain with symptom duration ≥ 12 weeks
* Insufficient response to conservative therapy, including but not limited to pharmacotherapy and/or physiotherapy
Exclusion Criteria
* Coagulopathy, systemic infection, localized infection at needle-entry site, lumbar fracture, myelopathy, or severe organ dysfunction (e.g., renal failure, heart failure, severe respiratory diseases)
* Comorbidities that compromise valid pain assessment (e.g., post-stroke, central neuropathy, malignancy)
* Previous neurological deficits
* Pregnancy
* Refusal of participation in the study
18 Years
ALL
No
Sponsors
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Faculty of Medicine, Gadjah Mada University
UNKNOWN
Sardjito General Hospital, Yogyakarta, Indonesia
UNKNOWN
Hasanuddin University
OTHER
Responsible Party
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dr. Farhan Ali Rahman, Sp. An-T.I., F.I.P.
Head of Education and Training Division RSUP Dr. Sardjito/Faculty of Medicine, Public Health, and Nursing Universitas Gadjah Mada
Principal Investigators
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Farhan A Rahman, MD
Role: PRINCIPAL_INVESTIGATOR
RSUP Dr. Sardjito/Faculty of Medicine, Public Health, and Nursing Universitas Gadjah Mada
Nur S Wirawan, MD
Role: STUDY_DIRECTOR
Department of Anesthesiology, Intensive Care, and Pain Management Hasanuddin University
Muhammad R Ahmad, MD
Role: STUDY_DIRECTOR
Department of Anesthesiology, Intensive Care, and Pain Management Hasanuddin University
Locations
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RSI Sultan Agung Islamic Teaching Hospital
Semarang, Central Java, Indonesia
Countries
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References
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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.
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.
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.
Other Identifiers
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28/KEPK-RSISA/I/2025
Identifier Type: -
Identifier Source: org_study_id