Effectiveness of High-Voltage PRF for Chronic Lumbosacral Radicular Pain

Effectiveness of High-Voltage Pulsed Radiofrequency for Chronic Lumbosacral Radicular Pain: A Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Lumbosacral Radicular Pain; Chronic Radicular Back Pain
• Intervention / Treatment: Device: Pulsed Radiofrequency; Drug: Post-operative Analgesia

Detailed Description

Consecutive patients who met the inclusion and exclusion criteria were enrolled and randomized into two groups: the intervention group (high-voltage PRF, 60 V) and the control group (low-voltage PRF, 45 V). The sample size was calculated using the Neyman-Pearson approach with a superiority hypothesis, assuming that the intervention group would achieve greater pain reduction than the control group. Accounting for an estimated 20% dropout rate, 11 participants were required per group. Patients who voluntarily withdrew from the study were excluded from analysis, whereas patients who discontinued the intervention due to adverse effects during or after the procedure were included in the analysis and reported.

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Indonesia
  • Central Java
    • Semarang, Central Java, Indonesia, 50112
      • RSI Sultan Agung Islamic Teaching Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adults aged ≥ 18 years old
• 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:

• Known hypersensitivity or allergy to medication required during the study (e.g., steroid, contrast media)
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard/Low-Voltage PRF at 45 V; Pulsed Radiofrequency set the voltage at 45 V.	Device: 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.; Other Names: PRF; Drug: 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 Names: Rescue Analgesia; Post-operative opioid
Experimental: High-Voltage PRF at 60 V; Pulsed Radiofrequency set the voltage at 60 V.	Device: 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.; Other Names: PRF; Drug: 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 Names: Rescue Analgesia; Post-operative opioid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in the Numeric rating scale (NRS-11) at Follow Up	Zero is equivalent to no pain and 10 indicates the worst possible pain.	Baseline (pre-intervention) through study completion, an average of 6 weeks.
Change from Baseline in the Visual Analog Scale (VAS) at Follow Up	The Visual Analogue Scale (VAS) is determined by measuring the distance (in millimeters) from the patient's mark on a 100mm line to the left end of the line. The left endpoint is equivalent to "no pain" and right endpoint represents the "worst imaginable pain."	Baseline (pre-intervention) through study completion, an average of 6 weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in Oswestry's Disability Index Score at Follow Up	The Oswestry Disability Index (ODI) was developed to evaluate the degree of disability associated with low back pain (LBP). An increase of 10% or more from the baseline ODI score is generally considered to indicate a clinically and statistically significant change in the patient's condition.	Baseline (pre-intervention) through study completion, an average of 6 weeks.
Change from Baseline in Serum Interleukin-6 at Follow Up	A reduction or maintenance of serum interleukin-6 levels from baseline at follow-up.	Baseline (pre-intervention) through study completion, an average of 6 weeks.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complication and Adverse Event	Any complications or adverse events that occurred during the procedure or afterward up to the follow-up period.	From enrollment through study completion, an average of 6 weeks.

Collaborators and Investigators

• Sponsor: Hasanuddin University
• Collaborators: Faculty of Medicine, Gadjah Mada University; Sardjito General Hospital, Yogyakarta, Indonesia
• Investigators: Principal Investigator: Farhan A Rahman, MD, RSUP Dr. Sardjito/Faculty of Medicine, Public Health, and Nursing Universitas Gadjah Mada; Study Director: Nur S Wirawan, MD, Department of Anesthesiology, Intensive Care, and Pain Management Hasanuddin University; Study Director: Muhammad R Ahmad, MD, Department of Anesthesiology, Intensive Care, and Pain Management Hasanuddin University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2025
• Primary Completion (Actual): April 29, 2025
• Study Completion (Actual): April 29, 2025

Study Registration Dates

• First Submitted: December 2, 2025
• First Submitted That Met QC Criteria: December 18, 2025
• First Posted (Actual): December 24, 2025

Study Record Updates

• Last Update Posted (Actual): December 24, 2025
• Last Update Submitted That Met QC Criteria: December 18, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: pain measurement; pulsed radiofrequency; visual analogue pain scale; chronic lumbosacral radicular pain; high-voltage
• Additional Relevant MeSH Terms: Therapeutics; Physical Therapy Modalities; Rehabilitation; Electric Stimulation Therapy; Radiofrequency Therapy; Pulsed Radiofrequency Treatment
• Other Study ID Numbers: 28/KEPK-RSISA/I/2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data (IPD) underlying the results presented in future publication will be made available to facilitate additional research in this area. Excluding identifiers -such as names, addresses, and medical record numbers.
• IPD Sharing Time Frame: The IPD will be available for 5 years, starting immediately after publication.
• IPD Sharing Access Criteria: The IPD will be accessible to all individuals who have access to the Google Drive link provided in the publication.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No