Effectiveness of High-Voltage PRF for Chronic Lumbosacral Radicular Pain

NCT07303309 | Completed DMC

• 1 other identifier: 28/KEPK-RSISA/I/2025
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lumbosacral Radicular Pain; Chronic Radicular Back Pain

Keywords

pain measurement; high-voltage; pulsed radiofrequency; chronic lumbosacral radicular pain; visual analogue pain scale

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Change from Baseline in Oswestry's Disability Index Score at Follow Up

  Baseline (pre-intervention) through study completion, an average of 6 weeks.

• Change from Baseline in Serum Interleukin-6 at Follow Up

  Baseline (pre-intervention) through study completion, an average of 6 weeks.

Other Outcomes (1)

• Complication and Adverse Event

  From enrollment through study completion, an average of 6 weeks.

Study Arms (2)

Standard/Low-Voltage PRF at 45 V

ACTIVE COMPARATOR

Pulsed Radiofrequency set the voltage at 45 V.

Device: Pulsed Radiofrequency; Drug: Post-operative Analgesia

High-Voltage PRF at 60 V

EXPERIMENTAL

Pulsed Radiofrequency set the voltage at 60 V.

Device: Pulsed Radiofrequency; Drug: Post-operative Analgesia

Interventions

Pulsed Radiofrequency DEVICE

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.

Also known as: PRF

High-Voltage PRF at 60 V; Standard/Low-Voltage PRF at 45 V

Post-operative Analgesia DRUG

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.

Also known as: Rescue Analgesia, Post-operative opioid

High-Voltage PRF at 60 V; Standard/Low-Voltage PRF at 45 V

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hasanuddin University: lead
• Faculty of Medicine, Gadjah Mada University: collaborator
• Sardjito General Hospital, Yogyakarta, Indonesia: collaborator

Study Sites (1)

RSI Sultan Agung Islamic Teaching Hospital

Semarang, Central Java, 50112, Indonesia

Location

Related Publications (3)

• 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.

  PMID: 27144851 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.

  PMID: 37976483 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.

  PMID: 36463027 BACKGROUND

MeSH Terms

Interventions

Pulsed Radiofrequency Treatment

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Radiofrequency Therapy; Rehabilitation

Study Officials

• Farhan A Rahman, MD

  RSUP Dr. Sardjito/Faculty of Medicine, Public Health, and Nursing Universitas Gadjah Mada

  PRINCIPAL INVESTIGATOR

• 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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Education and Training Division RSUP Dr. Sardjito/Faculty of Medicine, Public Health, and Nursing Universitas Gadjah Mada

Model Details: Standard/Low-voltage pulsed radiofrequency (45V) was compared with high-voltage pulsed radiofrequency (60 V)

Study Record Dates

• First Submitted: December 2, 2025
• First Posted: December 24, 2025
• Study Start: February 7, 2025
• Primary Completion: April 29, 2025
• Study Completion: April 29, 2025
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: The IPD will be available for 5 years, starting immediately after publication.
• Access Criteria: The IPD will be accessible to all individuals who have access to the Google Drive link provided in the publication.

Locations

ID (1)