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Not yet recruiting NCT07514117

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

No phase Interventional Bell Palsy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: sham EA, Electroacupunture(continuous pulse pattern), Electroacupuncture(intermittent pulse pattern).
Who it may be relevant to
Registry conditions: Bell Palsy. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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.

Interventions

  • 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 la
  • 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
  • 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

Primary outcome measures

  • Facial Nerve Grading System 2.0(FNGS 2.0) [Time frame: 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.]
Secondary outcome measures (3)
  • Sunnybrook Grading Scale(SBGS) [Time frame: 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.]
  • Facial Disability Index (FDI) [Time frame: Day 0, end of week 2, end of week 4.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 33240204

Identifiers

NCT: NCT07514117 · 2025-KL-067-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗