Elektroakupunktur med to pulsmonstre til Bells parese ved brug af overfladeelektromyografi-evaluering (EABP-SEMG)
31. august 2026 opdateret af: Ruohan Sun, The First Affiliated Hospital of Zhejiang Chinese Medical University
Elektroakupunktur med forskellige pulsmonstre hos patienter i den post-akute fase af Bell's parese: en studieprotokol for en randomiseret kontrolleret undersøgelse med overfladeelektromyografi-evaluering
Dette kliniske forsøg er designet til at evaluere de terapeutiske effekter af to EA-parameterindstillinger for Bell's parese og at undersøge sygdommens elektromyografiske karakteristika. De vigtigste spørgsmål, det sigter mod at besvare, er:
- Kan kontinuerlig pulsmonster og intermitterende pulsmonster af EA forbedre symptomerne ved Bell's parese?
- Påvirker kontinuerlig pulsmonster og intermitterende pulsmonster af EA de elektromyografiske karakteristika af ansigtsmuskler hos patienter med Bell's parese? Forskerne vil evaluere effekterne af kontinuerlig pulsmonster og intermitterende pulsmonster i behandlingen af Bell's parese ved at bruge overfladeelektromyografi som en objektiv indikator for vurdering. Forsøget varer i 4 uger, og behandlingsperioden varer i 4 uger.
Deltagerne vil:
- modtage placebo-EA, EA med et kontinuerligt pulsmonster eller EA med et intermitterende pulsmonster 3 gange ugentligt i 4 uger (12 sessioner i alt).
- modtage vurdering af symptomernes sværhedsgrad og social funktion på dag 0, slutningen af uge 2, slutningen af uge 4.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
111
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Ruohan Sun
- Telefonnummer: 86-15757194080
- E-mail: srh1207@163.com
Undersøgelse Kontakt Backup
- Navn: Lexuan Li
- Telefonnummer: 86-13588838759
- E-mail: lilexuan00@163.com
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
Inklusionskriterier:
- klinisk diagnosticeret som BP, med billeddannende bevis (hjerne CT og/eller MRI) der udelukker centralnervesystem-læsioner forbundet med ansigtslammelse
- sygdomsvarighed på 21 dage til 6 måneder, inklusive
- alder 18-70 år
- frivillig deltagelse og afgivelse af skriftlig informeret samtykke
Eksklusionskriterier:
- ansigtslammelse forårsaget af andre sygdomme
- tidligere historie med ansigtslammelse
- præsenterer med ansigtsmuskelspasmer, synkinesi eller kontraktur
- diagnosticeret som Ramsey-Hunt Syndrom
- tidligere ansigtsoperation
- med implanteret hjertestimulator
- gravide eller ammende patienter
- sammen med andre svære ukontrollerede sygdomme, erkendelsesforstyrrelse, afasi eller psykiske lidelser
- præsenterer med bilateral ansigtslammelse
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Sham-komparator: sham EA
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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.
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Eksperimentel: elektroakupunktur med et kontinuerligt pulsmonster
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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.
|
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Eksperimentel: Elektroakupunktur med en intermitterende pulsform
|
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.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Facial Nerve Grading System 2.0(FNGS 2.0)
Tidsramme: Day 0, end of week 2, end of week 4, 6 months after the disease onset.
|
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.
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Day 0, end of week 2, end of week 4, 6 months after the disease onset.
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Root Mean Square ratio(RMS%)
Tidsramme: Day 0, end of week 2, end of week 4, 6 months after the disease onset.
|
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.
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Day 0, end of week 2, end of week 4, 6 months after the disease onset.
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Median Frequency ratio (MDF%)
Tidsramme: Day 0, end of week 2, end of week 4, 6 months after the disease onset.
|
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, 6 months after the disease onset.
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Sunnybrook Grading Scale(SBGS)
Tidsramme: Day 0, end of week 2, end of week 4, 6 months after the disease onset.
|
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, 6 months after the disease onset.
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Facial Disability Index (FDI)
Tidsramme: Day 0, end of week 2, end of week 4, 6 months after the disease onset.
|
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, 6 months after the disease onset.
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Dalrymple SN, Row JH, Gazewood J. Bell Palsy: Rapid Evidence Review. Am Fam Physician. 2023 Apr;107(4):415-420.
- Tiemstra JD, Khatkhate N. Bell's palsy: diagnosis and management. Am Fam Physician. 2007 Oct 1;76(7):997-1002.
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. september 2026
Primær færdiggørelse (Anslået)
1. oktober 2027
Studieafslutning (Anslået)
1. december 2027
Datoer for studieregistrering
Først indsendt
29. marts 2026
Først indsendt, der opfyldte QC-kriterier
5. april 2026
Først opslået (Faktiske)
7. april 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
2. september 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
31. august 2026
Sidst verificeret
1. august 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2025-KL-067-01
Plan for individuelle deltagerdata (IPD)
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IPD-planbeskrivelse
Individual participant data (IPD) collected in this study will not be made available to other researchers.
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