Ton Gil, Lee Li-Wen, Ho Wen-Chao, Tu Cheng-Hao, Chen Yi-Hung, Lee Yu-Chen
College of Chinese medicine, Graduate Institute of Acupuncture Science, China Medical University, Taichung 40402, Taiwan.
Department of Acupuncture, China Medical University Hospital, Taichung 40402 Taiwan.
J Lasers Med Sci. 2021 Nov 6;12:e70. doi: 10.34172/jlms.2021.70. eCollection 2021.
Inadequate recovery from Bell's palsy exists in a third of patients and results in physical and social impairments. The controversial nature of existing medical treatment options means that novel, alternative approaches are needed. In basic and clinical studies, low-level laser therapy (LLLT) has proven successful in regenerating peripheral nerves. Laser acupuncture therapy (LAT) is a rapidly growing treatment modality; however, its effectiveness for treating chronic Bell's palsy is unknown. The feasibility of this innovative approach is the focus of this pilot study. A two-armed, parallel, randomized, investigator-subject-assessor-blinded, sham-controlled pilot study was conducted, and 17 eligible subjects were randomly allocated to either LAT (n=8) or sham LAT (n=9). The LAT group received three treatments each week for six weeks (18 sessions), while the sham LAT group received the same procedure but with a sham laser device. The change from baseline to week 6 in the social subscale of the Facial Disability Index (FDI) was the primary outcome. Secondary outcomes were changes in the House-Brackmann facial paralysis scale (HB), the Sunnybrook facial grading system (SB) and a stiffness scale at weeks 3 and 6. A significant difference was shown in the HB score (=0.0438) between baseline and week 3 and borderline significance was observed in both SB and stiffness scores from baseline to week 6 (=0.0598 and =0.0980 respectively). There was no significant difference in the FDI score between baseline and week 6. To the best of our knowledge, this clinical trial is the first such investigation on this topic. Our findings suggest that using LAT may have clinical effects on long-term complications of Bell's palsy and justify further large-scale studies.
三分之一的贝尔面瘫患者恢复不充分,会导致身体和社交功能受损。现有医学治疗方案存在争议,这意味着需要新的替代方法。在基础和临床研究中,低强度激光疗法(LLLT)已被证明能成功促进周围神经再生。激光针灸疗法(LAT)是一种迅速发展的治疗方式;然而,其治疗慢性贝尔面瘫的有效性尚不清楚。这项创新性方法的可行性是本初步研究的重点。开展了一项双臂、平行、随机、研究者 - 受试者 - 评估者双盲、假对照的初步研究,17名符合条件的受试者被随机分配至LAT组(n = 8)或假LAT组(n = 9)。LAT组每周接受三次治疗,共六周(18次疗程),而假LAT组接受相同操作,但使用的是假激光设备。面部残疾指数(FDI)社会亚量表从基线到第6周的变化是主要结局。次要结局是第3周和第6周时House - Brackmann面瘫分级量表(HB)、阳光布鲁克面部分级系统(SB)以及一个僵硬量表的变化。基线至第3周时HB评分显示出显著差异(P = 0.0438),从基线至第6周时SB评分和僵硬评分均观察到临界显著性(分别为P = 0.0598和P = 0.0980)。基线至第6周时FDI评分无显著差异。据我们所知,这项临床试验是关于该主题的首次此类研究。我们的研究结果表明,使用LAT可能对贝尔面瘫的长期并发症有临床效果,值得进一步开展大规模研究。