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Bell PalsyEABP-SEMGNCT07514117

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

A study testing Electroacupunture(continuous pulse pattern) and Electroacupuncture(intermittent pulse pattern) in people with Bell Palsy, run by The First Affiliated Hospital of Zhejiang Chinese Medical University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Bell Palsy
What is being tested?
Electroacupunture(continuous pulse pattern) and Electroacupuncture(intermittent pulse pattern)
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
111 participants
Where
No sites listed yet
Study dates
Sep 2026to Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • pregnancy or lactation
  • along with other severe uncontrolled diseases, recognition disorder, aphasia or mental disorders
  • present with bilateral facial paralysis

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

About this study

Official 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

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.
Read more

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.
Conditions
Bell Palsy
Being tested
sham EA, Electroacupunture(continuous pulse pattern), Electroacupuncture(intermittent pulse pattern)
Keywords
Bell's palsy, surface electromyography, randomized controlled trial, electroacupuncture
Medical subject headings
Bell Palsy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • sham EAProcedure or surgery

    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 or surgery

    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 or surgery

    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.

Study groups in NCT07514117
Study groupRoleWhat they receive
sham EASham comparatorNot described
Receives: Procedure: sham EA
electroacupunture with a continuous pulse patternExperimentalNot described
Receives: Procedure: Electroacupunture(continuous pulse pattern)
Electroacupuncture with a intermittent pulse patternExperimentalNot described
Receives: Procedure: Electroacupuncture(intermittent pulse pattern)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Day 0, end of week 2, end of week 4, 6 months after the disease onset.

Secondary outcomes (4)
  1. 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.

    Measured: Day 0, end of week 2, end of week 4, 6 months after the disease onset.

  2. 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.

    Measured: Day 0, end of week 2, end of week 4, 6 months after the disease onset.

  3. 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.

    Measured: Day 0, end of week 2, end of week 4, 6 months after the disease onset.

  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.

    Measured: Day 0, end of week 2, end of week 4, 6 months after the disease onset.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Apr 2026
  2. Study startSep 2026 (estimated)
  3. Primary completionOct 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
111 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07514117
Sponsor's protocol ID
2025-KL-067-01
Acronym
EABP-SEMG
Status last verified
Aug 2026
First submitted
29 Mar 2026
Last updated
2 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data (IPD) collected in this study will not be made available to other researchers.

Publications

  • Funk PF, Schneider R, Schramm M, Volk GF, Anders C, Guntinas-Lichius O. Bilateral muscle activation in postparalytic facial synkinesis: a cross-sectional high-resolution surface electromyography study. Sci Rep. 2026 Jan 14;16(1):2057. doi: 10.1038/s41598-026-36015-1.

    PubMed 41535392
  • 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.

    PubMed 40389431
  • Balbinot G, Joner Wiest M, Li G, Pakosh M, Cesar Furlan J, Kalsi-Ryan S, Zariffa J. The use of surface EMG in neurorehabilitation following traumatic spinal cord injury: A scoping review. Clin Neurophysiol. 2022 Jun;138:61-73. doi: 10.1016/j.clinph.2022.02.028. Epub 2022 Mar 19.

    PubMed 35364465
  • Li J, Kang X, Li K, Xu Y, Wang Z, Zhang X, Guo Q, Ji R, Hou Y. Clinical significance of dynamical network indices of surface electromyography for reticular neuromuscular control assessment. J Neuroeng Rehabil. 2023 Dec 20;20(1):170. doi: 10.1186/s12984-023-01297-3.

    PubMed 38124144
  • Guntinas-Lichius O, Volk GF, Olsen KD, Makitie AA, Silver CE, Zafereo ME, Rinaldo A, Randolph GW, Simo R, Shaha AR, Vander Poorten V, Ferlito A. Facial nerve electrodiagnostics for patients with facial palsy: a clinical practice guideline. Eur Arch Otorhinolaryngol. 2020 Jul;277(7):1855-1874. doi: 10.1007/s00405-020-05949-1. Epub 2020 Apr 8.

    PubMed 32270328
  • Balbinot G, Li G, Wiest MJ, Pakosh M, Furlan JC, Kalsi-Ryan S, Zariffa J. Properties of the surface electromyogram following traumatic spinal cord injury: a scoping review. J Neuroeng Rehabil. 2021 Jun 29;18(1):105. doi: 10.1186/s12984-021-00888-2.

    PubMed 34187509
  • Pozzi M, Rezoagli E, Bronco A, Rabboni F, Grasselli G, Foti G, Bellani G. Accessory and Expiratory Muscles Activation During Spontaneous Breathing Trial: A Physiological Study by Surface Electromyography. Front Med (Lausanne). 2022 Mar 10;9:814219. doi: 10.3389/fmed.2022.814219. eCollection 2022.

    PubMed 35372418
  • Felici F, Del Vecchio A. Surface Electromyography: What Limits Its Use in Exercise and Sport Physiology? Front Neurol. 2020 Nov 6;11:578504. doi: 10.3389/fneur.2020.578504. eCollection 2020.

    PubMed 33240204
  • Cassoni A, Catalano C, Di Giorgio D, Raponi I, Di Brino M, Perotti S, Valentini V. Masseter-facial neurorrhaphy for facial palsy reanimation: What happens after masseter denervation? Histomorphometric and stomatognathic functional analysis. J Craniomaxillofac Surg. 2020 Jul;48(7):680-684. doi: 10.1016/j.jcms.2020.04.009. Epub 2020 Jun 2.

    PubMed 32507669
  • Aoyagi M, Saito O, Tojima H, Maeyama H, Koike Y. Distribution of facial nerve conduction velocities in patients with Bell's palsy. Eur Arch Otorhinolaryngol. 1994 Dec:S514-6. doi: 10.1007/978-3-642-85090-5_205. No abstract available.

    PubMed 10774437
  • Eviston TJ, Croxson GR, Kennedy PG, Hadlock T, Krishnan AV. Bell's palsy: aetiology, clinical features and multidisciplinary care. J Neurol Neurosurg Psychiatry. 2015 Dec;86(12):1356-61. doi: 10.1136/jnnp-2014-309563. Epub 2015 Apr 9.

    PubMed 25857657
  • Sun J, Liu G, Sun Y, Lin K, Zhou Z, Cai J. Application of Surface Electromyography in Exercise Fatigue: A Review. Front Syst Neurosci. 2022 Aug 11;16:893275. doi: 10.3389/fnsys.2022.893275. eCollection 2022.

    PubMed 36032326
  • Karthick PA, Ghosh DM, Ramakrishnan S. Surface electromyography based muscle fatigue detection using high-resolution time-frequency methods and machine learning algorithms. Comput Methods Programs Biomed. 2018 Feb;154:45-56. doi: 10.1016/j.cmpb.2017.10.024. Epub 2017 Nov 9.

    PubMed 29249346
  • Khan AJ, Szczepura A, Palmer S, Bark C, Neville C, Thomson D, Martin H, Nduka C. Physical therapy for facial nerve paralysis (Bell's palsy): An updated and extended systematic review of the evidence for facial exercise therapy. Clin Rehabil. 2022 Nov;36(11):1424-1449. doi: 10.1177/02692155221110727. Epub 2022 Jul 5.

    PubMed 35787015
  • Baugh RF, Basura GJ, Ishii LE, Schwartz SR, Drumheller CM, Burkholder R, Deckard NA, Dawson C, Driscoll C, Gillespie MB, Gurgel RK, Halperin J, Khalid AN, Kumar KA, Micco A, Munsell D, Rosenbaum S, Vaughan W. Clinical practice guideline: Bell's palsy. Otolaryngol Head Neck Surg. 2013 Nov;149(3 Suppl):S1-27. doi: 10.1177/0194599813505967.

    PubMed 24189771

Questions about this trial

What is this clinical trial studying?

A study testing Electroacupunture(continuous pulse pattern) and Electroacupuncture(intermittent pulse pattern) in people with Bell Palsy, run by The First Affiliated Hospital of Zhejiang Chinese Medical University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ruohan Sun (86-15757194080, srh1207@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Facial Nerve Grading System 2.0(FNGS 2.0) (time frame: Day 0, end of week 2, end of week 4, 6 months after the disease onset.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07514117, which also lists 19 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.

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