About this trial
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
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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;
Trial design
Parallel
Treatments tested in this trial
electroacupuncture waveform
Procedure/SurgeryThe 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.
Treatment groups
Trial outcomes
Primary outcomes
FNGS2.0
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 outcomes
Sunnybrook Facial Grading System,SBGS
1.SBGS:Score range: 0-100, with higher scores indicating better facial nerve function.
Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: