NCT07598175尚未招募不适用
Study on the Optimal Waveform Patterns of Electroacupuncture Targeted Intervention for Bell's Palsy Based on Surface Electromyography Characteristics
The Third Affiliated hospital of Zhejiang Chinese Medical University0 个研究点目标入组 100 人开始时间: 2026年9月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 主要终点
- FNGS2.0
研究概览
简要总结
The goal of this clinical study is to find out whether different electronic acupuncture wave forms can effectively treat recovery-stage Bell's palsy in adults and evaluate their safety.
The main questions it aims to answer are:
- Can targeted electronic acupuncture wave forms improve facial nerve function in patients with Bell's palsy?
- What is the optimal electronic acupuncture waveform for different degrees of facial nerve injury?
- What adverse events may occur during electronic acupuncture treatment? Researchers will compare low-frequency continuous wave electronic acupuncture and intermittent wave electronic acupuncture to determine which waveform works better for recovery-stage Bell's palsy.
Participants will:
- Receive either low-frequency continuous wave electronic acupuncture or intermittent wave electronic acupuncture every other day for 4 weeks
- Undergo surface sEMG and ENoG examinations at baseline, Week 2, and Week 4
- Complete facial function assessments and safety evaluations at each clinic visit
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •for Bell's Palsy Subjects：
- •Meet the above Bell's palsy diagnostic criteria;
- •Age 18-65 years, either gender;
- •Disease course in recovery phase (21 days ≤ course ≤ 6 months) and not recovered (FNGS 2.0 score >4);
- •Voluntarily participate in this study and sign informed consent.
- •Inclusion Criteria for Healthy Subjects：
- •Do not meet the above Bell's palsy diagnostic criteria;
- •Age 18-65 years, either gender, matched to Bell's palsy subjects within 5 years for age and gender;
- •Normal facial nerve function, FNGS 2.0 score = 4;
- •Voluntarily participate in this study and sign informed consent.
排除标准
- •for Bell's Palsy Subjects：
- •Facial trauma, skin lesions, or other diseases that may cause facial paralysis symptoms;
- •Diagnosed with Ramsay Hunt syndrome (herpes zoster oticus);
- •Bilateral facial paralysis;
- •Previous history of facial paralysis;
- •Facial synkinesis, contracture, or spasm already present;
- •History of facial surgery;
- •Uncontrolled diabetes, hypertension, severe cardiac, hepatic, or renal disease, cognitive impairment, aphasia, or mental disorders;
- •Pacemaker use;
- •Pregnant or lactating patients.
- •Exclusion Criteria for Healthy Subjects：
- •Facial trauma, skin lesions, or other diseases that may affect facial muscle activity;
- •Previous history of facial paralysis;
- •History of facial surgery;
- •Uncontrolled diabetes, hypertension, severe cardiac, hepatic, or renal disease, cognitive impairment, aphasia, or mental disorders;
- •Pacemaker use;
- •Pregnant or lactating patients.
研究组 & 干预措施
Severe injury + Low-frequency continuous wave
Experimental
干预措施: electroacupuncture waveform (Procedure)
Non-severe injury + Interrupted wave
Experimental
干预措施: electroacupuncture waveform (Procedure)
Severe injury + Interrupted wave
Experimental
干预措施: electroacupuncture waveform (Procedure)
Non-severe injury + Low-frequency continuous wave
Experimental
干预措施: electroacupuncture waveform (Procedure)
结局指标
主要结局
FNGS2.0
时间窗: week4
FNGS 2.0 stands for Facial Nerve Grading System 2.0, with a total score range of 4 to 24; lower scores indicate better facial nerve function (4 = normal), while higher scores indicate more severe facial paralysis (24 = complete facial palsy).
次要结局
- Sunnybrook Facial Grading System,SBGS(week4)
研究者
Jing Sun
Associate Professor
The Third Affiliated hospital of Zhejiang Chinese Medical University
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