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Study on the Optimal Waveform Patterns of Electroacupuncture Targeted Intervention for Bell's Palsy Based on Surface Electromyography Characteristics
The goal of this clinical study is to find out whether different electronic acupuncture wave forms can effectively treat recovery-stage Bell's palsy in adults and evaluate their safety.
The main questions it aims to answer are:
- Can targeted electronic acupuncture wave forms improve facial nerve function in patients with Bell's palsy?
- What is the optimal electronic acupuncture waveform for different degrees of facial nerve injury?
- What adverse events may occur during electronic acupuncture treatment? Researchers will compare low-frequency continuous wave electronic acupuncture and intermittent wave electronic acupuncture to determine which waveform works better for recovery-stage Bell's palsy.
Participants will:
- Receive either low-frequency continuous wave electronic acupuncture or intermittent wave electronic acupuncture every other day for 4 weeks
- Undergo surface sEMG and ENoG examinations at baseline, Week 2, and Week 4
- Complete facial function assessments and safety evaluations at each clinic visit
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Jing Sun
- Telefoonnummer: 13429610268
- E-mail: sunjing0268@163.com
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
Inclusion Criteria for Bell's Palsy Subjects:
- Meet the above Bell's palsy diagnostic criteria;
- Age 18-65 years, either gender;
- Disease course in recovery phase (21 days ≤ course ≤ 6 months) and not recovered (FNGS 2.0 score >4);
- Voluntarily participate in this study and sign informed consent.
Inclusion Criteria for Healthy Subjects:
- Do not meet the above Bell's palsy diagnostic criteria;
- Age 18-65 years, either gender, matched to Bell's palsy subjects within 5 years for age and gender;
- Normal facial nerve function, FNGS 2.0 score = 4;
- Voluntarily participate in this study and sign informed consent.
Exclusion Criteria for Bell's Palsy Subjects:
- Facial trauma, skin lesions, or other diseases that may cause facial paralysis symptoms;
- Diagnosed with Ramsay Hunt syndrome (herpes zoster oticus);
- Bilateral facial paralysis;
- Previous history of facial paralysis;
- Facial synkinesis, contracture, or spasm already present;
- History of facial surgery;
- Uncontrolled diabetes, hypertension, severe cardiac, hepatic, or renal disease, cognitive impairment, aphasia, or mental disorders;
- Pacemaker use;
- Pregnant or lactating patients.
Exclusion Criteria for Healthy Subjects:
- Facial trauma, skin lesions, or other diseases that may affect facial muscle activity;
- Previous history of facial paralysis;
- History of facial surgery;
- Uncontrolled diabetes, hypertension, severe cardiac, hepatic, or renal disease, cognitive impairment, aphasia, or mental disorders;
- Pacemaker use;
- Pregnant or lactating patients.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Non-severe injury + Low-frequency continuous wave
|
The non-severe injury group was randomly divided into two subgroups: one treated with low-frequency continuous wave and the other with intermittent wave.The severe injury group was also randomly divided into two subgroups: one treated with low-frequency continuous wave and the other with intermittent wave.
|
|
Experimenteel: Non-severe injury + Interrupted wave
|
The non-severe injury group was randomly divided into two subgroups: one treated with low-frequency continuous wave and the other with intermittent wave.The severe injury group was also randomly divided into two subgroups: one treated with low-frequency continuous wave and the other with intermittent wave.
|
|
Experimenteel: Severe injury + Low-frequency continuous wave
|
The non-severe injury group was randomly divided into two subgroups: one treated with low-frequency continuous wave and the other with intermittent wave.The severe injury group was also randomly divided into two subgroups: one treated with low-frequency continuous wave and the other with intermittent wave.
|
|
Experimenteel: Severe injury + Interrupted wave
|
The non-severe injury group was randomly divided into two subgroups: one treated with low-frequency continuous wave and the other with intermittent wave.The severe injury group was also randomly divided into two subgroups: one treated with low-frequency continuous wave and the other with intermittent wave.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
FNGS2.0
Tijdsspanne: week4
|
FNGS 2.0 stands for Facial Nerve Grading System 2.0, with a total score range of 4 to 24; lower scores indicate better facial nerve function (4 = normal), while higher scores indicate more severe facial paralysis (24 = complete facial palsy).
|
week4
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Sunnybrook Facial Grading System,SBGS
Tijdsspanne: week4
|
1.SBGS:Score range: 0-100, with higher scores indicating better facial nerve function.
|
week4
|
Medewerkers en onderzoekers
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- GZY-KJS-ZJ-2026-056
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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