Electroacupuncture With Two Pulse Patterns for Bell's Palsy Using Surface Electromyography Evaluation (EABP-SEMG)

April 27, 2026 updated by: Ruohan Sun, The First Affiliated Hospital of Zhejiang Chinese Medical University

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

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

111

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: sham EA
Procedure: sham EA
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.
Experimental: electroacupunture with a continuous pulse pattern
Procedure: Electroacupunture(continuous pulse pattern)
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.
Experimental: Electroacupuncture with a intermittent pulse pattern
Procedure: Electroacupuncture(intermittent pulse pattern)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 0, end of week 2, end of week 4.
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.
Day 0, end of week 2, end of week 4.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 0, end of week 2, end of week 4.
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.
Day 0, end of week 2, end of week 4.
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.
Day 0, end of week 2, end of week 4.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital of Zhejiang Chinese Medical University

Collaborators

The Third Affiliated hospital of Zhejiang Chinese Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

March 29, 2026

First Submitted That Met QC Criteria

April 5, 2026

First Posted (Actual)

April 7, 2026

Study Record Updates

Last Update Posted (Actual)

April 30, 2026

Last Update Submitted That Met QC Criteria

April 27, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-KL-067-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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