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Not Yet RecruitingNCT07514117

Electroacupuncture With Two Pulse Patterns for Bell's Palsy Using Surface Electromyography Evaluation

Electroacupuncture With Different Pulse Patterns in Patients With Post-acute Phase of Bell's Palsy: a Study Protocol for a Randomized Controlled Trial With Surface Electromyography Evaluation

Status
Not Yet Recruiting
Phase
N/A
Study type
Interventional
Enrollment
111 (estimated)
Sponsor
The First Affiliated Hospital of Zhejiang Chinese Medical University · Academic / Other
Sex
All
Age
18 Weeks – 70 Weeks
Healthy volunteers
Not accepted

Summary

This clinical trial is designed to evaluate the therapeutic effects of two EA parameter settings for Bell's palsy and to investigate the electromyographic characteristics of the disease. The main questions it aims to answer are: * Can continuous pulse pattern and intermittent pulse pattern of EA improve the symptoms of Bell's palsy? * Do continuous pulse pattern and intermittent pulse pattern of EA impact the electromyographic characteristics of facial muscles in patients with Bell's palsy? The researchers will evaluate the effects of continuous pulse pattern and intermittent pulse pattern in treating Bell's palsy by using surface electromyography as an objective indicator of assessment. The trial lasts for 4 weeks and the treatment period lasts for 4 weeks. Participants will: * receive sham EA, EA with a continuous pulse pattern or EA with an intermittent pulse pattern for 3 times weekly for 4 weeks (12 sessions in total). * receive assessment of symptom severity and social functioning on Day 0, end of week 2, end of week 4.

Conditions

Interventions

TypeNameDescription
PROCEDUREsham EAsham EA: Participants will receive electroacupuncture with no current on acupoints with disposable stainless-steel needles with a specification of 0.25mm\*40mm and 0.18mm\*25mm (Suzhou Medical Products Factory Co., Ltd, China). The acupoints prescription in all groups are shown below: Cuanzhu (BL2), Sizhukong (SJ23), Yuyao (EX-HN4), Yangbai (GB14) (and 1 cun bilateral to GB14 and 1 cun medial to GB14), Tongziliao (GB1), Quanliao (SI18), Dicang (ST4), Daying (ST5), Jiache (ST6), Jiachengjiang (EX-HN), Yifeng (SJ17), Sibai (ST2), Yingxiang (LI20), Hegu (LI14), Taiyang(EX-HN5) on the affected side.
PROCEDUREElectroacupunture(continuous pulse pattern)The acupuncture points for the continuous pulse pattern group were the same as those in the sham EA group. A continuous pulse pattern at 2 Hz was used for electrical stimulation. Each treatment session will last 30 min each time, and participants will receive treatment 3 times per week for 4 weeks, for a total of 12 sessions.
PROCEDUREElectroacupuncture(intermittent pulse pattern)The acupuncture points for the intermittent pulse pattern group were the same as those in the sham EA group. An intermittent pulse pattern at 35 Hz was used for electrical stimulation. Each treatment session will last 30 min each time, and participants will receive treatment 3 times per week for 4 weeks, for a total of 12 sessions.

Timeline

Start date
2026-05-01
Primary completion
2026-12-01
Completion
2027-02-01
First posted
2026-04-07
Last updated
2026-04-07

Source: ClinicalTrials.gov record NCT07514117. Inclusion in this directory is not an endorsement.