Ton Gil, Lee Li-Wen, Ng Hui-Ping, Liao Hsien-Yin, Chen Yi-Hung, Tu Cheng-Hao, Tseng Chun-Hung, Ho Wen-Chao, Lee Yu-Chen
Graduate Institute of Acupuncture Science.
Department of Acupuncture.
Medicine (Baltimore). 2019 Apr;98(15):e15120. doi: 10.1097/MD.0000000000015120.
Bell's palsy is the most frequent cause of unilateral peripheral facial palsy, a common condition that third of patients can have inadequate recovery and subsequent physical and social impairments. The largely ineffective and even controversial nature of the various medical and surgical treatment options means that novel, alternative approaches are needed. In preclinical and clinical evidence, low-level laser therapy (LLLT) has demonstrated the ability to regenerate peripheral nerves. Laser acupuncture treatment (LAT), the stimulation of traditional acupoints with low-intensity, non-thermal laser irradiation, is a common treatment modality, but its efficacy in chronic Bell's palsy is undetermined. This study aims to evaluate the efficacy of LAT in patients experiencing inadequate recovery from Bell's palsy.
This 2-armed, parallel, randomized, subject-assessor-blinded, single-center, sham-controlled pilot trial will randomly assign 32 eligible patients into either a real LAT group (n = 16) or a sham LAT group (n = 16). The real LAT group will receive 3 LAT sessions each week for 6 weeks (a total of 18 sessions), delivered to acupoints corresponding with the affected side of the face. The sham LAT group will receive the same treatment as the real LAT group, but with a sham laser device. The primary outcome measure will be the change from baseline at week 6 in the Facial Disability Index score. Secondary outcomes will monitor changes during treatment in the House-Brackmann and Sunnybrook facial nerve grading systems and stiffness scale, at weeks 1, 3, and 6.
To the best of our knowledge, this double-blind, randomized, sham-controlled trial is the first such investigation into the efficacy of LAT in chronic Bell's palsy. Clinical trials using LLLT have shown positive therapeutic effects in acute Bell's palsy, although as yet, the feasibility and efficacy of LAT remain unclear in patients experiencing inadequate recovery from Bell's palsy.
This trial protocol has been approved by the Research Ethics Committee of the China Medical University Hospital, Taichung, Taiwan (Protocol ID: CMUH107-REC1-030) also registered at ClinicalTrials.gov (identifier no. NCT03592797).
贝尔麻痹是单侧周围性面瘫最常见的病因，这是一种常见病症，三分之一的患者恢复不佳，继而出现身体和社交功能障碍。各种药物和手术治疗方案大多效果不佳甚至存在争议，这意味着需要新的替代方法。临床前和临床证据表明，低强度激光疗法（LLLT）具有使周围神经再生的能力。激光针刺疗法（LAT），即使用低强度、非热激光照射刺激传统穴位，是一种常见的治疗方式，但其对慢性贝尔麻痹的疗效尚不确定。本研究旨在评估LAT对贝尔麻痹恢复不佳患者的疗效。
这项双臂、平行、随机、受试者和评估者双盲、单中心、假对照的试点试验将把32名符合条件的患者随机分为真正的LAT组（n = 16）或假LAT组（n = 16）。真正的LAT组将每周接受3次LAT治疗，共6周（总共18次），照射患侧面部相应的穴位。假LAT组将接受与真正的LAT组相同的治疗，但使用假激光设备。主要结局指标将是第6周时面部残疾指数评分相对于基线的变化。次要结局指标将监测治疗期间第1、3和6周时House - Brackmann和Sunnybrook面神经分级系统及僵硬量表的变化。
据我们所知，这项双盲、随机、假对照试验是首次对LAT治疗慢性贝尔麻痹的疗效进行此类研究。使用LLLT的临床试验已显示对急性贝尔麻痹有积极的治疗效果，尽管目前LAT在贝尔麻痹恢复不佳患者中的可行性和疗效仍不明确。
本试验方案已获得中国台湾台中市中国医药大学附设医院研究伦理委员会批准（方案编号：CMUH107 - REC1 - 030），并在ClinicalTrials.gov注册（标识符编号：NCT03592797）。
