Study on the Optimal Waveform Patterns of Electroacupuncture Targeted Intervention for Bell's Palsy Based on Surface Electromyography Characteristics

ConditionBell's Palsy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorThe Third Affiliated hospital of Zhejiang Chinese Medical University

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • electroacupuncture waveform

    Procedure/Surgery

    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.

Treatment groups

100 Participants
are divided into 4 treatment groups
Group A: Non-severe injury + Low-frequency continuous waveExperimental treatment 1 intervention
Group B: Non-severe injury + Interrupted waveExperimental treatment 1 intervention
Group C: Severe injury + Low-frequency continuous waveExperimental treatment 1 intervention
Group D: Severe injury + Interrupted waveExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame
week4

Secondary outcomes

1

Sunnybrook Facial Grading System,SBGS

1.SBGS:Score range: 0-100, with higher scores indicating better facial nerve function.

Time frame
week4

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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