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| Name | Class |
|---|---|
| The Third Affiliated hospital of Zhejiang Chinese Medical University | OTHER |
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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:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sham EA | Sham Comparator |
| |
| electroacupunture with a continuous pulse pattern | Experimental |
| |
| Electroacupuncture with a intermittent pulse pattern | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 0, end of week 2, end of week 4. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ruohan Sun | Contact | 86-15757194080 | srh1207@163.com | |
| Lexuan Li | Contact | 86-13588838759 | lilexuan00@163.com |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41535392 | Background | 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. | |
| 40389431 | Background | 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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| 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-â…¡B, 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. |
|
| 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. |
| Day 0, end of week 2, end of week 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. | Day 0, end of week 2, end of week 4. |
| 35364465 | Background | 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. |
| 38124144 | Background | 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. |
| 32270328 | Background | 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. |
| 34187509 | Background | 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. |
| 35372418 | Background | 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. |
| 33240204 | Background | 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. |
| 32507669 | Background | 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. |
| 10774437 | Background | 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. |
| 25857657 | Background | 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. |
| 36032326 | Background | 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. |
| 29249346 | Background | 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. |
| 35787015 | Background | 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. |
| 24189771 | Background | 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. |
| 31709978 | Background | Heckmann JG, Urban PP, Pitz S, Guntinas-Lichius O, Gagyor I. The Diagnosis and Treatment of Idiopathic Facial Paresis (Bell's Palsy). Dtsch Arztebl Int. 2019 Oct 11;116(41):692-702. doi: 10.3238/arztebl.2019.0692. |
| 37054419 | Background | Dalrymple SN, Row JH, Gazewood J. Bell Palsy: Rapid Evidence Review. Am Fam Physician. 2023 Apr;107(4):415-420. |
| 17956069 | Background | Tiemstra JD, Khatkhate N. Bell's palsy: diagnosis and management. Am Fam Physician. 2007 Oct 1;76(7):997-1002. |
| 23136264 | Background | Gronseth GS, Paduga R; American Academy of Neurology. Evidence-based guideline update: steroids and antivirals for Bell palsy: report of the Guideline Development Subcommittee of the American Academy of Neurology. Neurology. 2012 Nov 27;79(22):2209-13. doi: 10.1212/WNL.0b013e318275978c. Epub 2012 Nov 7. |
| ID | Term |
|---|---|
| D020330 | Bell Palsy |
| ID | Term |
|---|---|
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D005155 | Facial Nerve Diseases |
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |
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