Photobiomodulation Therapy for Facial Paralysis Over 8 Weeks: An Open-Label Pilot, Non-concurrent Control Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- The House-Brackmann Facial Nerve Grading System
研究概览
简要总结
Objective: Facial paralysis can be caused by a variety of etiological factors, complete palsy continues for two months, the chance of full recovery is reduced to zero. The aim of this study was to evaluate the effectiveness of photobiomodulation therapy (PBMT) in the in patients undergoing facial paralysis over 8 weeks.
Methods: This study was an open-label, not concurrent control study including 54 patients that underwent facial paralysis over 8 weeks. Patients were assigned to the PBMT group and control group, with 27 patients in each group. Laser treatments were applied 3 days a week after recruited. PBMT was delivered using a class IV Multi-wave Locked System that combines with a simultaneous 808 nm continuous emission and 905 nm pulse emission and the maximum peak power was 25 W. Clinical outcome measure comprised the House-Brackmann grading system, Facial Clinimetric Evaluation Scale (FaCE), Sunnybrook facial grading scale (SBFG), and electrophysiological testing, including Electroneuronography (ENoG), Electromyography (EMG) and Blink Reflex. All the measurements were collected at the first day and at the end of study. All reported P values were two-sided and were declared statistically significant when less than 0.05.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(1) adults over 18 years of age and under 65 years of age. (2) had not received medicine, such as prednisolone. (3) had history of Bell's palsy, Ramsay Hunt syndrome, traumatic facial paralysis and history of otological surgery.
- •(4) Disease duration longer than two months.
排除标准
- •(1) Complete facial paralysis (HB 6). (2) Greater than 90% denervation on ENoG. (3) No voluntary EMG activity. (4) No latency of early (R1) and late (R2, R2') components in blink reflex. (5) Serious mental illness or social problems, and neurological disorders. (6) Systemic disease, such as severe diabetes, malignant tumors and other serious consumptive diseases.
- •(7) Planning for pregnancy, in pregnancy or lactation.
结局指标
主要结局
The House-Brackmann Facial Nerve Grading System
时间窗: Change from Baseline number of pathological HB grading at 6-months in post-therapy.
The House-Brackmann facial nerve grading system (HB grading) is based on a 6-grade score that offers a gross evaluation of facial motor function and includes the evaluation of sequelae. The prognoses of patients with House-Brackmann grade I or grade II were considered good, and the prognoses of those with grade 3 or higher were considered poor.
The Sunnybrook Facial Grading System
时间窗: Change from Baseline scores of SB grading at at 6-months in post-therapy.
The Sunnybrook facial grading system (SB grading) is 13-items, self-reported questionnaire that used to evaluate the facial movement of patients. Among the overall 13 items of question, 3 items are resting symmetry, 5 items are symmetry of voluntary movement, and 5 items are synkinesis. Lower scores of Sunnybrook equate to greater severity of facial paralysis symptoms.
Facial Clinimetric Evaluation Scale
时间窗: Change from Baseline scores of FaCE at at 6-months in post-therapy.
The Facial Clinimetric Evaluation Scale (FaCE) is 15-items, self-reported questionnaire that used to assess facial impairment and disability after facial paralysis. Among the overall 15 items of question, FaCE grouped into six independent domains: social function, facial movement, facial comfort, oral function, eye comfort, and lacrimal control. Each using a five-item Likert scale. A participant circles the most appropriate response to a given statement, whereby 1 corresponds to the lowest function and 5 corresponds to the highest function. The total score is ranged 0 (worst) to 100 (best).
次要结局
- Electromyography (EMG)(Change from Baseline amplitude and duration of MUAPs at at 6-months in post-therapy.)
- Blink Reflex(Change from Baseline number of pathological Blink Reflex at 6-months in post-therapy.)
- Electroneuronography (ENoG)(Change from Baseline amplitude and potential of CAMP and the numbers of pathological ENoG at at 6-months in post-therapy.)