Electroacupuncture With Different Pulse Patterns for the Post-acute Phase of Bell's Palsy: a Study Protocol for a Randomized Controlled Trial With Surface Electromyography Evaluation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 111
- 主要终点
- Facial Nerve Grading System 2.0(FNGS 2.0)
研究概览
简要总结
This clinical trial is designed to evaluate the therapeutic effects of two EA parameter settings for Bell's palsy and to investigate the electromyographic characteristics of the disease. The main questions it aims to answer are:
- Can continuous pulse pattern and intermittent pulse pattern of EA improve the symptoms of Bell's palsy?
- Do continuous pulse pattern and intermittent pulse pattern of EA impact the electromyographic characteristics of facial muscles in patients with Bell's palsy? The researchers will evaluate the effects of continuous pulse pattern and intermittent pulse pattern in treating Bell's palsy by using surface electromyography as an objective indicator of assessment. The trial lasts for 4 weeks and the treatment period lasts for 4 weeks.
Participants will:
- receive sham EA, EA with a continuous pulse pattern or EA with an intermittent pulse pattern for 3 times weekly for 4 weeks (12 sessions in total).
- receive assessment of symptom severity and social functioning on Day 0, end of week 2, end of week 4 and 6 months after the disease onset.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosed clinically as BP, with imaging evidence (brain CT and/or MRI) excluding central nervous system lesions associated with facial palsy
- •the disease duration of 21 days to 3 months, inclusive
- •age 18-70 years
- •voluntary participation and provision of written informed consent
- •receipt of prednisolone during the acute phase at a daily dose of 30-60 mg for at least 5 days
排除标准
- •facial paralysis caused by diseases other than Bell's palsy
- •previous facial paralysis
- •present with facial muscle spasm, synkinesis or contracture
- •Ramsay Hunt syndrome
- •history of facial surgery
- •implanted cardiac pacemakers
- •pregnancy or lactation
- •along with other severe uncontrolled diseases, recognition disorder, aphasia or mental disorders
- •present with bilateral facial paralysis
研究组 & 干预措施
sham EA
干预措施: sham EA (Procedure)
Electroacupuncture with a intermittent pulse pattern
干预措施: Electroacupuncture(intermittent pulse pattern) (Procedure)
electroacupunture with a continuous pulse pattern
干预措施: Electroacupunture(continuous pulse pattern) (Procedure)
结局指标
主要结局
Facial Nerve Grading System 2.0(FNGS 2.0)
时间窗: Day 0, end of week 2, end of week 4.
FNGS 2.0 is a clinician-rated scale widely used to evaluate the severity of facial nerve dysfunction based on resting symmetry, voluntary facial movements, and synkinesis, with a composite score ranging from 4 to 24. The total score is categorized into Grade I (normal function) to Grade VI (complete paralysis), with higher scores and grades indicating worse facial nerve dysfunction.
Root Mean Square ratio (RMS%)
时间窗: Day 0, end of week 2, end of week 4.
RMS is an assessment parameter of surface electromyography, and it reflects the amplitude of muscle electrical activity during facial movements. RMS% is the comparison of RMS values between affected side and healthy side, and it can help quantify the degree of recovery and objectively assess the facial muscle activation.
Facial Nerve Grading System 2.0(FNGS 2.0)
时间窗: Day 0, end of week 2, end of week 4, 6 months after the disease onset.
FNGS 2.0 is a clinician-rated scale widely used to evaluate the severity of facial nerve dysfunction based on resting symmetry, voluntary facial movements, and synkinesis, with a composite score ranging from 4 to 24. The total score is categorized into Grade I (normal function) to Grade VI (complete paralysis), with higher scores and grades indicating worse facial nerve dysfunction.
次要结局
- Sunnybrook Grading Scale(SBGS)(Day 0, end of week 2, end of week 4.)
- Median Frequency ratio (MDF%)(Day 0, end of week 2, end of week 4.)
- Facial Disability Index (FDI)(Day 0, end of week 2, end of week 4.)
- Root Mean Square ratio(RMS%)(Day 0, end of week 2, end of week 4, 6 months after the disease onset.)
- Median Frequency ratio (MDF%)(Day 0, end of week 2, end of week 4, 6 months after the disease onset.)
- Sunnybrook Grading Scale(SBGS)(Day 0, end of week 2, end of week 4, 6 months after the disease onset.)
- Facial Disability Index (FDI)(Day 0, end of week 2, end of week 4, 6 months after the disease onset.)
研究者
Ruohan Sun
Physician, Department of Acupuncture
The First Affiliated Hospital of Zhejiang Chinese Medical University