Abstract
BackgroundFacial 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.MethodsThis is a patient-assessor blinded, randomized, sham-controlled trial. A total of fifty-six eligible patients will be randomly divided into TEA (n=28) and sham TEA (STEA) (n=28) groups. Both groups will receive TEA or STEA treatment at the frontal muscle and the depressor anguli oris muscle, at one predefined points once a week for eight weeks. Additionally, both groups will receive traditional acupuncture treatment at ten acupoints (GB20, LI4, LR3, GB12, ST7, SI18, LI20, BL2, SJ23, ST4) twice a week for eight weeks as a concurrent treatment. B-mode ultrasonography will be used to assess the changes in facial expression muscle thickness ratio of the affected/healthy side at baseline and at 10 weeks after screening, as the primary outcome. House-Brackmann Grade and lip mobility score will be measured and analyzed at baseline and 4, 8, 10, and 12 weeks after screening, as secondary outcomes.DiscussionThe study will compare TEA with sham TEA to explore the feasibility for TEA in improving facial expression muscles atrophy after peripheral facial paralysis.Trial registrationChinese Clinical Trial Registry, ChiCTR1900027170. Registered on 3 November 2019, http://www.chictr.org.cn/edit.aspx?pid=45173&htm=4
Highlights
Facial expression muscles atrophy is one kind of sequelae after peripheral facial paralysis
Peripheral facial paralysis (PFP) patients with level 3-5 injury can develop sequelae [2, 3] based on the Sunderland Classification system [4]
facial expression muscles atrophy (FEMA) is ignored by patients and doctors since it occurs in the deep layer below the skin [5, 6]
Summary
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. Peripheral facial paralysis (PFP) is caused by peripheral neuronal lesions of the facial nerve, which can be either primary (Bell’s Palsy) or secondary [1]. PFP patients with level 3-5 injury can develop sequelae [2, 3] based on the Sunderland Classification system [4]. The PFP sequelae include synkinesis, contracture, spasm, crocodile tear syndrome, and facial expression muscles atrophy (FEMA) [5]. FEMA symptoms negatively impact the quality of life by causing psychological or social problems [8,9,10]
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