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NCT Number: NCT07598175

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

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

electroacupuncture waveform

Procedure

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.

Primary outcomes

  1. FNGS2.0

    Time frame: week4

Secondary outcomes

  1. Sunnybrook Facial Grading System,SBGS

    Time frame: week4

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

Study contacts

Contact information is provided by the study sponsor or research team.

Jing Sun

CONTACT

[email protected]

13429610268

Sponsors and collaborators

Lead sponsor

The Third Affiliated hospital of Zhejiang Chinese Medical University

Other

Registry information

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
May 20, 2026
Registry last updated
May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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