NCT06063954

Two Electroacupuncture Waveforms for Different Severity Groups of Bell Palsy

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: The Third Affiliated hospital of Zhejiang Chinese Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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) received attention as an alternative and complementary treatment method. The low-frequency continuous wave EA and the intermittent wave EA have been used in the management of BP. The aim of this study is to compare the efficacy and safety of these two electroacupuncture waveforms for different severity groups of BP.

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) of the affected side comparing to normal side is 20% or higher. And the investigators will recruit 60 patients with BP whose ENoG test indicate a severe damage, as indicated by the ratio of amplitude of the CMAP of the affected side comparing to normal side is less than 20%. Both the two types of patients will be randomly divided into either the low-frequency continuous wave group, or the intermittent wave group, and receive 4 weeks treatment. The primary outcomes is change from baseline score of the Facial Nerve Grading System 2.0. The secondary outcomes are change from baseline score of the Sunnybrook grading scale, and change from baseline value of the amplitude of the CMAP of the affected side in the ENoG test.

Conditions

• Bell Palsy

Interventions

Type	Name	Description
OTHER	electroacupuncture	Electroacupuncture (EA) is a form of acupuncture in which a weak electric current is passed through the acupuncture needles into acupoints in the skin.

Timeline

• Start date: 2023-11-15
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2023-10-03
• Last updated: 2024-10-21

Locations

3 sites across 1 country: China