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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
22
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.
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.
RSI Sultan Agung Islamic Teaching Hospital
Semarang, Central Java, Indonesia
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.
Time frame: 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."
Time frame: Baseline (pre-intervention) through study completion, an average of 6 weeks.
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.
Time frame: 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.
Time frame: Baseline (pre-intervention) through study completion, an average of 6 weeks.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.