Bell's Palsy
Conditions
Brief summary
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
Interventions
PROCEDUREelectroacupuncture waveform
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.
Sponsors
The Third Affiliated hospital of Zhejiang Chinese Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| FNGS2.0 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sunnybrook Facial Grading System,SBGS | week4 | 1.SBGS：Score range: 0-100, with higher scores indicating better facial nerve function. |
Contacts
CONTACTJing Sun
Outcome results
None listed