Effects of Laser Acupuncture Therapy for Patients With Inadequate Recovery From Bell's Palsy: Preliminary Results From Randomized, Double-Blind, Sham-Controlled Study

Introduction: 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. Methods: 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. Results: A significant difference was shown in the HB score (P=0.0438) between baseline and week 3 and borderline significance was observed in both SB and stiffness scores from baseline to week 6 (P=0.0598 and P=0.0980 respectively). There was no significant difference in the FDI score between baseline and week 6. Conclusion: 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.