Incomplete recovery from facial palsy results in social and physical disabilities, and the medical options for the sequelae of Bell’s palsy are limited. Acupuncture is widely used for Bell’s palsy patients in East Asia, but its efficacy is unclear. We performed a randomized controlled trial including participants with the sequelae of Bell’s palsy with the following two parallel arms: an acupuncture group (n = 26) and a waiting list group (n = 13). The acupuncture group received acupuncture treatments for 8 weeks, whereas the waiting list group did not receive acupuncture treatments during the 8-week period after randomization. The primary outcome measure was change in the Facial Disability Index (FDI) social and well-being subscale at week 8. We also analyzed changes in the FDI physical function subscale, the House–Brackmann score, the Sunnybrook Facial Nerve Grading system, lip mobility and stiffness at 5 and 8 weeks after randomization. An intention-to-treat analysis was applied. The acupuncture group exhibited greater improvements in the FDI social score (mean difference, 23.54; 95 % confidence interval, 12.99 to 34.08) and better results on the FDI physical function subscale (mean difference, 21.54; 95 % confidence interval, 7.62 to 35.46), Sunnybrook Facial Nerve Grading score (mean difference, 14.77; 95 % confidence interval, 5.05 to 24.49), and stiffness scale (mean difference, −1.58; 95 % confidence interval,−2.26 to −0.89) compared with the waiting list group after 8 weeks. No severe adverse event occurred in either group. Compared with the waiting list group, acupuncture had better therapeutic effects on the social and physical aspects of sequelae of Bell’s palsy. Current Controlled Trials ISRCTN43104115 .
Objective: Incomplete recovery from facial palsy has a long-term impact on the quality of life, and medical options for the sequelae of Bell's palsy are limited. Invasive treatments and physiotherapy have been employed to relieve symptoms, but there is limited clinical evidence for their effectiveness. Acupuncture is widely used on Bell's palsy patients in East Asia, but there is insufficient evidence for its effectiveness on Bell's palsy sequelae. The objective is to evaluate the efficacy and safety of acupuncture in patients with sequelae of Bell's palsy. Method/Design: This study consists of a randomized controlled trial with two parallel arms: an acupuncture group and a waitlist group. The acupuncture group will receive acupuncture treatment three times per week for a total of 24 sessions over 8 weeks. Participants in the waitlist group will not receive any acupuncture treatments during this 8 week period, but they will participate in the evaluations of symptoms at the start of the study, at 5 weeks and at 8 weeks after randomization, at which point the same treatment as the acupuncture group will be provided. The primary outcome will be analyzed by the change in the Facial Disability Index (FDI) from baseline to week eight. The secondary outcome measures will include FDI from baseline to week five, House-Brackmann Grade, lip mobility, and stiffness scales. Trial registration: Current Controlled-Trials ISRCTN43104115; registration date: 06 July 2010; the date of the first patient's randomization: 04 August 2010