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

NCT07514117 | Not Yet Recruiting DMC

• 1 other identifier: 2025-KL-067-01
• Study Type: interventional
• Target: 111
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Bell Palsy

Keywords

Bell's palsy; surface electromyography; randomized controlled trial; electroacupuncture

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Day 0, end of week 2, end of week 4.

Secondary Outcomes (3)

• 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.

Study Arms (3)

sham EA

SHAM COMPARATOR

Procedure: sham EA

electroacupunture with a continuous pulse pattern

EXPERIMENTAL

Procedure: Electroacupunture(continuous pulse pattern)

Electroacupuncture with a intermittent pulse pattern

EXPERIMENTAL

Procedure: Electroacupuncture(intermittent pulse pattern)

Interventions

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.

sham EA

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.

electroacupunture with a continuous pulse pattern

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.

Electroacupuncture with a intermittent pulse pattern

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The First Affiliated Hospital of Zhejiang Chinese Medical University: lead
• The Third Affiliated hospital of Zhejiang Chinese Medical University: collaborator

Related Publications (19)

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• Schneider R, Schramm M, Funk PF, Volk GF, Anders C, Guntinas-Lichius O. Synchronous surface electromyography as objective method to evaluate the outcome of a biofeedback training in patients with facial synkinesis. Sci Rep. 2025 May 19;15(1):17335. doi: 10.1038/s41598-025-01278-7.

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MeSH Terms

Conditions

Bell Palsy

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Ruohan Sun

CONTACT

86-15757194080; srh1207@163.com

Lexuan Li

CONTACT

86-13588838759; lilexuan00@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician, Department of Acupuncture

Study Record Dates

• First Submitted: March 29, 2026
• First Posted: April 7, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 30, 2026

Record last verified: 2026-04