Comparing two types of electroacupuncture for treating Bell Palsy

A Randomized Trial Comparing Two Electroacupuncture Waveforms for Different Severity Groups of Bell Palsy

This study is testing two different types of electroacupuncture to see which one helps people with Bell Palsy, depending on how severe their facial nerve damage is.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: The Third Affiliated hospital of Zhejiang Chinese Medical University (Academic / other)
• Locations: 3 sites (Hangzhou, Zhejiang and 2 other locations)
• Trial ID: NCT06063954 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the efficacy and safety of two different electroacupuncture waveforms in patients with Bell Palsy, categorized by the severity of their condition. A total of 120 patients will be recruited, with 60 having mild to moderate facial nerve damage and 60 with severe damage, as determined by the ENoG test. Participants will be randomly assigned to receive either low-frequency continuous wave electroacupuncture or intermittent wave electroacupuncture for four weeks. The primary outcome will be assessed using the Facial Nerve Grading System 2.0, while secondary outcomes will include additional grading scales and electrophysiological measures.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 65 diagnosed with Bell Palsy and showing specific facial nerve damage as indicated by ENoG testing.

Not a fit: Patients with facial palsy due to other causes, severe comorbid conditions, or those who have had previous facial surgeries may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for patients suffering from Bell Palsy.

How similar studies have performed: While electroacupuncture has been explored in other studies, this specific comparison of waveforms for Bell Palsy is a novel approach.

Eligibility criteria

Inclusion Criteria:

1. Diagnosed as BP by specialist.
2. The score of FNGS 2.0 ≥ 15 at the day 21 since the onset of BP.
3. 18 years ≤ age ≤ 65 years.
4. Received prednisolone within 72 hours since initial symptoms of BP, the prednisolone dose used was 60 mg per day for 5 days and then reduced by 10 mg per day.
5. Signed informed consent and volunteered to participate in this study.

Exclusion Criteria:

1. Facial palsy caused by other diseases or injury.
2. Ramsey-Hunt syndrome.
3. Bilateral facial palsy.
4. History of previous facial palsy.
5. Manifesting facial spasm, facial synkinesis or contracture at day 21 since the onset of BP.
6. History of surgery on face.
7. Combined with uncontrolled diabetes mellitus, uncontrolled hypertension, serious heart, liver, kidney damage or cognitive impairment, aphasia, mental disorders.
8. Installing pacemakers.
9. Pregnant and lactating patients.

Where this trial is running

Hangzhou, Zhejiang and 2 other locations

• The First Affiliated Hospital of Zhejiang Chinese Medical University — Hangzhou, Zhejiang, China (Recruiting)
• The Third Affiliated hospital of Zhejiang Chinese Medical University — Hangzhou, Zhejiang, China (Recruiting)
• Hangzhou First People' s Hospital, Hangzhou — Hangzhou, Zhejing, China (Recruiting)

Study contacts

• Principal investigator: Jing Sun, MD, Ph.D — The Third Affiliated hospital of Zhejiang Chinese Medical University
• Study coordinator: Jing Sun, MD, Ph.D

Conditions Bell Palsy; Bell palsy; Acupuncture treatment; Clinical study