Efficacy and Safety of Thread Embedding Acupuncture for Facial Expression Muscles Atrophy After Peripheral Facial Paralysis: Study Protocol for a Randomized Controlled Trial

Abstract

Background Facial expression muscles atrophy is one kind of sequelae after peripheral facial paralysis. It causes critical problems in facial appearance of patient as well as social and psychological problems. This study aims to evaluate the efficacy and safety of Thread-embedding acupuncture (TEA) for the management of facial expression muscles atrophy after peripheral facial paralysis. Methods This is a patient-assessor blinded, randomized, sham-controlled trial. A total of 56 eligible patients will be randomly allocated to a TEA group (n = 28) or a sham TEA (STEA) group (n = 28). Both groups will receive TEA or STEA treatment at 2 predefined points once a week for 8 weeks. Additionally, both groups will receive the same acupuncture treatment twice a week for 8 weeks as a concurrent treatment. Changes in facial expression muscle thickness ratio of the affected/healthy side measured by B-mode ultrasonography will be assessed at baseline and at 10 weeks after screening as the primary outcome. Furthermore, the House-Brackmann Grade and lip mobility score will be measured and analyzed as secondary outcomes. Secondary outcomes will be assessed at baseline and at 4, 8, 10 and 12 weeks after screening. Discussion The study will compare TEA with sham TEA to explore the feasibility for TEA in improving symptoms caused by facial expression muscles atrophy after peripheral facial paralysis. Trial registration: Chinese Clinical Trial Registry, ChiCTR1900027170. Registered on 3 November 2019, http://www.chictr.org.cn/edit.aspx?pid=45173&htm=4