Effectiveness of High-Voltage PRF for Chronic Lumbosacral Radicular Pain

Hasanuddin University

Status: Completed

Conditions: Lumbosacral Radicular Pain; Chronic Radicular Back Pain

Treatments: Device: Pulsed Radiofrequency; Drug: Post-operative Analgesia

Study type: Interventional

Funder types: Other

Identifiers

NCT07303309

28/KEPK-RSISA/I/2025

Details and patient eligibility

About

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.

Full 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.

Enrollment: 22 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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22 participants in 2 patient groups

Standard/Low-Voltage PRF at 45 V

Active Comparator group

Description:

Pulsed Radiofrequency set the voltage at 45 V.

Treatment:

Drug: Post-operative Analgesia

Device: Pulsed Radiofrequency

High-Voltage PRF at 60 V

Experimental group

Description:

Pulsed Radiofrequency set the voltage at 60 V.

Treatment:

Drug: Post-operative Analgesia

Device: Pulsed Radiofrequency