Clinical efficacy and safety of thread-embedding acupuncture for treatment of the sequelae of Bell's palsy: A protocol for a patient-assessor blinded, randomized, controlled, parallel clinical trial

BACKGROUND: The sequelae of Bell's palsy cause critical problem in facial appearance, as well as social and psychological problems in the patient's life. The aim of the present study is to establish clinical evidence of thread-embedding acupuncture (TEA) in the treatment of sequelae of Bell's palsy. METHOD/DESIGN: This is a patient-assessor blinded, randomized, sham-controlled trial with two parallel arms. Fifty-six patients aged 19–65 years, who have experienced sequelae of Bell's palsy for >3 months, will be recruited and screened using the eligibility criteria. After screening, they will be randomly allocated to a TEA group or a sham TEA (STEA) group. Both groups will receive TEA or STEA treatment on ten predefined acupoints 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 the Facial Disability Index over 8 weeks will be assessed as the primary outcome. Furthermore, the House-Brackmann Grade, Facial Nerve Grading System 2.0, Sunnybrook Facial Grading System, facial stiffness score, lip mobility score, and treatment satisfaction score will be measured and analyzed as secondary outcomes. All outcomes will be assessed at baseline and at 4 and 8 weeks after screening. DISCUSSION: The results from this trial will help establish clinical evidence regarding the efficacy and safety of TEA in the treatment of patients with sequelae of Bell's palsy. TRIAL REGISTRATION NUMBER: KCT0002557 (Clinical Research Information Service of the Republic of Korea).