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Completed

NCT Number: NCT07303309

Effectiveness of High-Voltage PRF for Chronic Lumbosacral Radicular Pain

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.

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Key information

Conditions

Lumbosacral Radicular Pain Chronic Radicular Back Pain

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

RSI Sultan Agung Islamic Teaching Hospital

Semarang, Central Java, 50112, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: PRF

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.

Other names: Rescue Analgesia, Post-operative opioid

Primary outcomes

  1. Change from Baseline in the Numeric rating scale (NRS-11) at Follow Up

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

    Zero is equivalent to no pain and 10 indicates the worst possible pain.

  2. Change from Baseline in the Visual Analog Scale (VAS) at Follow Up

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

    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."

Secondary outcomes

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

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

    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.

  2. Change from Baseline in Serum Interleukin-6 at Follow Up

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

    A reduction or maintenance of serum interleukin-6 levels from baseline at follow-up.

Other outcomes

  1. Complication and Adverse Event

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

    Any complications or adverse events that occurred during the procedure or afterward up to the follow-up period.

Sponsors and collaborators

Lead sponsor

Hasanuddin University

Other

Collaborators

  • Faculty of Medicine, Gadjah Mada University
  • Sardjito General Hospital, Yogyakarta, Indonesia

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 24, 2025
Registry last updated
Dec 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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