Status:
RECRUITING
Two Electroacupuncture Waveforms for Different Severity Groups of Bell Palsy
Lead Sponsor:
The Third Affiliated hospital of Zhejiang Chinese Medical University
Collaborating Sponsors:
The First Affiliated Hospital of Zhejiang Chinese Medical University
Zhejiang University
Conditions:
Bell Palsy
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Bell palsy (BP) is the most common cause of acute facial palsy, which leads to functional and esthetic disturbances for patients and results in a lowered quality of life. Electroacupuncture (EA) recei...
Detailed Description
The investigators will recruit 60 patients with BP whose ENoG test indicate a mild to moderate facial nerve damage, as indicated by the ratio of amplitude of the compound muscle action potential (CMAP...
Eligibility Criteria
Inclusion
- Diagnosed as BP by specialist.
- The score of FNGS 2.0 ≥ 15 at the day 21 since the onset of BP.
- 18 years ≤ age ≤ 65 years.
- 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.
- Signed informed consent and volunteered to participate in this study.
Exclusion
- Facial palsy caused by other diseases or injury.
- Ramsey-Hunt syndrome.
- Bilateral facial palsy.
- History of previous facial palsy.
- Manifesting facial spasm, facial synkinesis or contracture at day 21 since the onset of BP.
- History of surgery on face.
- Combined with uncontrolled diabetes mellitus, uncontrolled hypertension, serious heart, liver, kidney damage or cognitive impairment, aphasia, mental disorders.
- Installing pacemakers.
- Pregnant and lactating patients.
Key Trial Info
Start Date :
November 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06063954
Start Date
November 15 2023
End Date
December 31 2025
Last Update
October 21 2024
Active Locations (3)
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1
The First Affiliated Hospital of Zhejiang Chinese Medical University
Hangzhou, Zhejiang, China, 310006
2
The Third Affiliated hospital of Zhejiang Chinese Medical University
Hangzhou, Zhejiang, China, 310053
3
Hangzhou First People' s Hospital, Hangzhou
Hangzhou, Zhejing, China, 310006