Bell's Palsy With a Duration of Greater Than 8 Weeks Treated With Multiwave Locked System Intervention: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- electroneuronography
研究概览
简要总结
OBJECTIVE: To determine whether photobiomodulation therapy by class IV Multiwave Locked System laser treatment could relieve symptoms in patients with Bell's palsy with a duration of greater than 8 weeks.
METHODS AND METHODS: This randomized controlled trial from May 2021 to April 2023. Patients were eligible who had Bell's palsy with a duration of greater than 8 weeks on out-patient department of otorhinolaryngology in Beijing Tongren Hospital. The photobiomodulation group received class IV Multiwave Locked System laser treatment for 3 times per weeks, a total of 6 months. The control group received the same Multiwave Locked System treatment procedure except the laser parameter. The primary outcome measures comprised House-Brackmann facial nerve grading system, Sunnybrook facial grading system, Facial Clinimetric Evaluation Scale. Secondary outcome measures comprised Electroneurography, Electromyography, and the Blink Reflex.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
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
- •Patients were eligible for House-Brackmann grading system (HB) greater than or equal to grade
- •Patients were adults over 18 years of age and under 60 years of age;
- •Patients were not received medicine before 2 weeks of trial, such as prednisolone.
排除标准
- •Patients were excluded HB grade 6, or greater than 90% denervation on electroneuronography, or no voluntary electromyography activity, or no latency of early (R1) and late (R2, R2') components in Blink Reflex patients.
- •Patients were excluded serious mental illness or social problems, and neurological disorders. And systemic disease, such as severe diabetes, malignant tumors, and other serious consumptive diseases, planning for pregnancy, in pregnancy or lactation.
研究组 & 干预措施
PBMT Group
In PBMT group, we choose 9 points on the affected face, include Mastoid, Preauricular, Temple, Frontalis muscle, Zygomatic muscle, Buccinator muscle, Masseter, Orbicularis oris and Depressor angulli oris. Based on clinical experience, we choose 7 acupoints, including LI4 (HeGu), LI11(QuChi), ST25 (TianShu), ST36 (ZuSanLi), SP6 (SanYinJiao), KI3 (TaiXi), LR3 (TaiChong). All the acupoint were applied bilaterally.
Laser divice directly contacts the points. All those points near the superficial roots of facial nerve. At each point, we treated for 1min, 1500 Hz, 50% laser intensity. And patients in PBMT group wore safety glasses to prevent eye damage during the laser sessions. All treatments were performed in the outpatient clinic by the same physician.
干预措施: Multiwave Locked System (Device)
Control Group
Patients in the control group received no intervention but were free to pursue therapies if desired.
干预措施: Multiwave Locked System (Device)
结局指标
主要结局
electroneuronography
时间窗: Change from Baseline amplitude and potential of CAMP and the numbers of pathological ENoG at at 6-months in post-therapy.]
The goal of the Electroneurography (ENoG) testing is to measure the amount of neural degradation that has occurred distal to the site of facial nerve injury by measuring the muscle response to an electrical stimulus. The testing of ENoG involves recording the compound muscle action potential (CAMP) of the mimetic muscles, including Orbicularis oculi, Frontalis muscle, Orbicularis oris and Zygomaticus muscle. ENoG is performed first on the healthy side of the face and then on the affected side. Nerve damage or nerve fiber degeneration leads to a decrease or loss of the CAMP. The amplitude of the CAMP on the affected side is compared to the CAMP of the healthy side and expressed as percent (amplitude of the paralyzed side divided by the amplitude of the normal side). A side difference of 30% or bigger is considered pathologic.
House-Brackmann 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.
次要结局
- Sunnybrook Facial Grading Scale(Change from Baseline number of pathological SB grading at 6-months in post-therapy.)
- electromyography(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)