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Effectiveness of High-Voltage PRF for Chronic Lumbosacral Radicular Pain

NCT07303309 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2025-12-24

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

  • Faculty of Medicine, Gadjah Mada University

    collaborator UNKNOWN

  • Sardjito General Hospital, Yogyakarta, Indonesia

    collaborator UNKNOWN

  • Hasanuddin University

    lead OTHER

Principal Investigators

  • Farhan A Rahman, MD · RSUP Dr. Sardjito/Faculty of Medicine, Public Health, and Nursing Universitas Gadjah Mada

  • Nur S Wirawan, MD · Department of Anesthesiology, Intensive Care, and Pain Management Hasanuddin University

  • Muhammad R Ahmad, MD · Department of Anesthesiology, Intensive Care, and Pain Management Hasanuddin University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-07
Primary Completion
2025-04-29
Completion
2025-04-29

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07303309 on ClinicalTrials.gov