Multi-center and randomized controlled clinical study of electro-acupuncture intervention in the treatment of Bell's facial paralysis

Abstract

Abstract Backgroud: Bell's facial paralysis is a disease that seriously endangers human health. Electroacupuncture therapy is considered to be effective in the treatment of this disease, but there is still a great controversy whether to use electroacupuncture in patients in the acute phase, and there is a lack of multi-center, large-sample clinical studies on different electroacupuncture parameters in the treatment of Bell's facial paralysis. The purpose of this study is to provide high-quality evidence for the clinic through multi-center, large-sample clinical study. Design: In this multicenter, double-blinded, randomized controlled clinical trial, a total of 330 patients with acute Bell's palsy aged 18 to 70 years were randomly divided into experimental group and control group. The experimental group was divided into 4 groups (A, B, C, D) according to different electroacupuncture parameters, with 66 participants in each group. The control group received ordinary acupuncture. The entire study period was 60 days, including 30 days of treatment observation and 1 month follow-up. House-Brackmann scale and facial nerve electrophysiological examination were used as the main efficacy evaluation indexes, Chinese medicine syndrome score evaluation scale and sequelae scale of Bell palsy were used as secondary efficacy indexes, and blood routine was used as safety indexes. The clinical evaluation time was before, 7 days after treatment, 14 days after treatment, 21 days after treatment, 28 days after treatment, and 1 month follow-up. The primary outcome of the postacupuncture effect were investigated by paired T-test, and the continuous outcome variables will be analyzed with univariate repetitive measurement deviation analysis. Adverse events will be noted and recorded for the safety evaluation. Conclusion: In this study, electroacupuncture wave type and frequency were used as control conditions to explore the efficacy and safety of electroacupuncture in the treatment of patients with acute Bell's palsy under different parameters. This study will provide reasonable stimulation parameters for electroacupuncture treatment of patients with acute Bell's palsy and provide strong evidence for the safety and effectiveness of electroacupuncture interventional therapy in acute stage. CHICTR registration number: ChiCTR1800015882. Registered in April 2018.