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Papers: 19 Sep 2020 - 25 Sep 2020

Human Studies

2020 Sep 16


Balloon compression versus radiofrequency for primary trigeminal neuralgia: a randomized, controlled trial.


Neto H S, Fukuda C Y, Duarte K P, Aparecida da Silva V, de Lima Rodrigues A L, Geront R G, de Siqueira SRDT, de Siqueira J T T, Teixeira M J, de Andrade D C
Pain. 2020 Sep 16.
PMID: 32947541.


Surgical procedures are necessary in up to 50% of trigeminal neuralgia (TN) patients. While radiofrequency (RF) is more widely used, it is associated with high intra-procedural costs and long technical learning time. Other simpler procedures such as balloon compression (BC) require a lower training period and have significant lower costs. We evaluated the effects of BC and RF in pain control in primary TN in a randomized, double-blinded, head-to-head trial. Individuals were randomly allocated in one of two groups: BC and RF. Throughout pain, psychological and quality of life measurements were performed at baseline and after surgery. The main outcome was the worst pain in the last 24 hours (0-10) at six months postoperatively. After the inclusion of half of the estimated sample, a pre-planned interim analysis was performed when thirty-three patients (62.1 ± 9.4 y.) completed the study. Pain intensity (CI95% 0.6-3.8, and -0.6-2.2, for BC and RF) did not significantly differ. Complications, interference of pain in daily life (CI95% -0.1-2.3 and -0.4-2.3, for BC and RF), neuropathic pain symptoms (CI95% 1.7-3.6 and 3.0-5.7, for BC and RF), mood (CI95% 4.8-11.5 and 5.5-15.1, BC and RF, respectively), medication use and quality of life (CI95% 80.4-93.1 and 83.9-94.2, for BC and RF) were also not different. RF presented more paresthetic symptoms than BC at 30 days following intervention. Based on these results, the study was halted due to futility as BC was not superior do RF.