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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
111
Non-acupoint locations approximately 5mm away from the following acupoints at the affected side will be selected for superficial needling to a depth of 1-2mm: Cuanzhu (BL2), Sizhukong (SJ23), Yuyao(EX-HN4), QiYangbai (three points including GB14, 1 cun medial to GB14, and 1 cun lateral to GB14), Tongziliao (GB1), Quanliao (Sl18), Dicang (ST4), Daying (ST5), Jiache (ST6), Jiachengjiang, Yifeng (SJ17), Sibai (ST2), Yingxiang (Ll20), Hegu (L114), Taiyang(EX-HN5). EA devices (Hwato SDZ-ⅡB, Suzhou Medical Supplies Co., Ltd.) will be connected to 4 paired points via specially customized wires lacking internal conductors: (1) non-acupoints near 1 cun medial to GB14 and 1 cun lateral to GB14, (2) non-acupoints near BL2 and GB1, (3) non-acupoints near ST4 and SI18, and (4) non-acupoints near Jiachengjiang and ST5. Each session of needling without actual current output will last 30 min, and participants will receive 3 sessions per week for 4 weeks, for a total of 12 sessions.
Acupoint selection for the continuous pulse pattern group will be guided by the principle of combining both local and distal acupoints: Cuanzhu (BL2), Sizhukong (SJ23), Yuyao(EX-HN4), QiYangbai (three points including GB14, 1 cun medial to GB14, and 1 cun lateral to GB14), Tongziliao (GB1), Quanliao (Sl18), Dicang (ST4), Daying (ST5), Jiache (ST6), Jiachengjiang, Yifeng (SJ17), Sibai (ST2), Yingxiang (Ll20), Hegu (L114), Taiyang(EX-HN5) on the affected side. EA devices (Hwato SDZ-ⅡB, Suzhou Medical Supplies Co., Ltd.) will be connected to 4 paired points: (1) 1 cun medial to GB14 and 1 cun lateral to GB14, (2) BL2 and GB1, (3)ST4 and SI18, and (4) Jiachengjiang and ST5. A continuous pulse pattern at 2 Hz will be used for electrical stimulation. Each session of EA treatment will last 30 min, and participants will receive 3 sessions per week for 4 weeks, for a total of 12 sessions.
Acupoint selection for the intermittent pulse pattern group will be guided by the principle of combining both local and distal acupoints: Cuanzhu (BL2), Sizhukong (SJ23), Yuyao(EX-HN4), QiYangbai (three points including GB14, 1 cun medial to GB14, and 1 cun lateral to GB14), Tongziliao (GB1), Quanliao (Sl18), Dicang (ST4), Daying (ST5), Jiache (ST6), Jiachengjiang, Yifeng (SJ17), Sibai (ST2), Yingxiang (Ll20), Hegu (L114), Taiyang(EX-HN5) on the affected side. EA devices (Hwato SDZ-ⅡB, Suzhou Medical Supplies Co., Ltd.) will be connected to 4 paired points: (1) 1 cun medial to GB14 and 1 cun lateral to GB14, (2) BL2 and GB1, (3)ST4 and SI18, and (4) Jiachengjiang and ST5. An intermittent pulse pattern at 35 Hz will be used for electrical stimulation. Each session of EA treatment will last 30 min, and participants will receive 3 sessions per week for 4 weeks, for a total of 12 sessions.
Facial Nerve Grading System 2.0(FNGS 2.0)
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.
Time frame: Day 0, end of week 2, end of week 4.
Root Mean Square ratio (RMS%)
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.
Time frame: Day 0, end of week 2, end of week 4.
Sunnybrook Grading Scale(SBGS)
The SBGS is a standardized clinician-rated scale used to assess the severity of facial muscle dysfunction. The score ranges from 0 to 100, with higher score indicating better facial nerve function. An increase in score over time reflects clinical improvement.
Time frame: Day 0, end of week 2, end of week 4.
Median Frequency ratio (MDF%)
MDF is one of the sEMG parameters which has potential value in revealing muscle characteristics, such as fatigue patterns. MDF% is the comparison of MDF values between affected side and healthy side.
Time frame: Day 0, end of week 2, end of week 4.
Facial Disability Index (FDI)
The FDI includes physical and social subscales. FDI is a patient-reported measure that assesses the physical and social impact of facial dysfunction. The score of each subscale ranges from 0 to 100, with higher scores indicating better function and less disability.
Time frame: Day 0, end of week 2, end of week 4.
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