Background: Lumbar radicular pain (LRP) is a common symptom, but a challenging clinical problem. Pulsed radiofrequency (PRF) is a more recently developed technique that uses short pulses of radiofrequency current with intervals of longer pauses to prevent temperature from rising to the level of permanent tissue damage and has been advocated in treatment of such patients. But there were no comparative studies on the analgesic effects according to output voltage during PRF in patients with LRP. The goal of this study is to determine the clinical effect of high-voltage (60V) versus standard-voltage (45V) PRF of lumbar dorsal root ganglion.
Methods/design: This study will be a prospective, double-blind randomized controlled pilot study. In this study, total 20 patients will be recruited and distributed equally into 2 groups: high-voltage (60V) PRF, low-voltage (45V) PRF. Outcomes will be radicular pain intensity; physical functioning; global improvement and satisfaction with treatment; and adverse events. The assessments will be performed at the 3-month follow-up period after the end of the treatments. The findings will be analyzed statistically considering a 5% significance level (P ≤ .05).
Discussion: The results of this trial will help determine which voltage could be applied for PRF to dorsal root ganglion in LRP and be a basis for subsequent trials.
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