Effects of Acupuncture for Bell's Palsy in Acute Phase: A Study Protocol for a Randomized Controlled Trial

Introduction: Acupuncture therapy has been widely used in the treatment of Bell’s palsy. There are no clinical trials conducted previously to evaluate the effect of acupuncture on facial nerve edema in Bell's palsy patients. The aim of this study is to evaluate the efficacy and facial nerve edema of acupuncture for Bell’s palsy in acute phase, and to preliminarily explore its possible mechanism. Methods and analysis: In this randomized single-blinded sham-controlled trial, 165 eligible patients will be recruited and randomly assigned to either the electroacupuncture group (n=33), the acupuncture group (n=33), the sham acupuncture group (n=33, the blank control group (n=33)or the acupuncture control group (n=33) in a 1:1:1:1:1 ratio. The participants will receive 4 weeks of treatment and 8 weeks of follow-up from day 3 of onset. The first four groups will receive either electroacupuncture, acupuncture, sham acupuncture or blank in addition to medication, and the last group will receive acupuncture alone. The primary outcome will be assessed using the Sunnybrook facial grading system and facial nerve diameter. The secondary outcomes will be measured by echo intensity and thickness of facial muscles, blood flow parameters of facial artery and House-Brackmann facial nerve grading system.The outcomes will be evaluated at baseline, day 5.10.20, week 8 and week 12 of the treatment. The variance analysis or nonparametric test and chi-square test will be used to compare the differences between the groups at baseline. The assessment of the difference between groups will be repeated measure analysis of covariance and trend chi square.