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NCT Number: NCT07514117

Electroacupuncture With Two Pulse Patterns for Bell's Palsy Using Surface Electromyography Evaluation

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.

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Key information

Conditions

Bell Palsy Cranial Nerve Diseases DNA Virus Infections Facial Nerve Diseases Herpesviridae Infections Infections Mouth Diseases Nervous System Diseases Stomatognathic Diseases Virus Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 6 months, inclusive
  • age 18-70 years
  • voluntary participation and provision of written informed consent

Exclusion criteria

  • facial paralysis caused by other diseases
  • have previous history of facial paralysis
  • present with facial muscle spasm, synkinesis or contracture
  • diagnosed as Ramsey-Hunt Syndrome
  • history of surgery on face
  • with cardiac pacemakers implanted
  • pregnant or lactating patients
  • along with other severe uncontrolled diseases, recognition disorder, aphasia or mental disorders
  • present with bilateral facial paralysis

Treatment and study plan

sham EA

Procedure

Non-acupoint locations approximately 5 mm away from the corresponding acupoints used in the continuous pulse pattern and intermittent pulse pattern groups will be selected. Superficial needling will be performed at these non-acupoints to a depth of 1-2 mm, without manual manipulation or intentional elicitation of the de qi sensation. EA devices 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. Needles will be retained for 30 min per session. Treatment will be administered three times per week for 4 weeks, for a total of 12 sessions.

Electroacupunture(continuous pulse pattern)

Procedure

Acupoint selection for the continuous pulse pattern group will be guided by the principle of combining both local and distal acupoints, with a depth of 5 to 30mm and de qi sensation: 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), Taiyang(EX-HN5) on the affected side, and Hegu (L114) bilaterally. 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, (4) Jiachengjiang and ST5. A continuous pulse pattern at 2 Hz will be used for electrical stimulation with intensity adjusted to the maximum tolerable level below the pain threshold. The EA treatment will last for 30 min per session, three times per week for 4 weeks, 12 sessions in total.

Electroacupuncture(intermittent pulse pattern)

Procedure

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), Taiyang(EX-HN5) on the affected side, and Hegu (L114) bilaterally. EA devices 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, with intensity adjusted to the maximum tolerable level below the pain threshold. The EA treatment will last for 30 min per session, three times per week for 4 weeks, 12 sessions in total.

Primary outcomes

  1. Facial Nerve Grading System 2.0(FNGS 2.0)

    Time frame: 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.

  2. Root Mean Square ratio (RMS%)

    Time frame: 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.

Secondary outcomes

  1. Sunnybrook Grading Scale(SBGS)

    Time frame: Day 0, end of week 2, end of week 4.

    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.

  2. Median Frequency ratio (MDF%)

    Time frame: Day 0, end of week 2, end of week 4.

    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.

  3. Facial Disability Index (FDI)

    Time frame: Day 0, end of week 2, end of week 4.

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Lexuan Li

CONTACT

[email protected]

86-13588838759

Ruohan Sun

CONTACT

[email protected]

86-15757194080

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Zhejiang Chinese Medical University

Other

Collaborators

  • The Third Affiliated hospital of Zhejiang Chinese Medical University

Registry information

Official study title

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

Acronym: EABP-SEMG

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 7, 2026
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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