EA Treatment With Different Waveform for Subacute BP:Study Protocol for a Randomized Controlled Trial
NCT Number: NCT06573697
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Bell Palsy
Interventions: OTHER: low-frequency continuous wave EA|OTHER: discontinuous wave EA|OTHER: dilatational wave EA
Sponsor: The Third Affiliated hospital of Zhejiang Chinese Medical University
Collaborators: The First Affiliated Hospital of Zhejiang Chinese Medical University|Zhejiang University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 90
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-15
Completion Date: 2025-09-15
Locations: The Third Affiliated hospital of Zhejiang Chinese Medical University, Hangzhou, Zhejiang, 310053, China

Summary:
Bell palsy (BP) is a relatively common clinical disease, which leads to functional and esthetic disturbances for patients and results in a lowered quality of life. Electroacupuncture received attention in the management of BP. The aim of this study is to evaluate the curative effect of different waveform of electroacupuncture on peripheral facial paralysis in subacute stage and to screen out the optimal waveform.

Primary Outcome Measures: Change from Baseline score of the Facial Nerve Grading System 2.0(FNGS 2.0), Evaluation of the facial nerve function using the Facial Nerve Grading System 2.0 (FNGS 2.0). In the FNGS 2.0, the minimal score is 4, which indicates normal function, and the maximal score is 24, which indicates the worst function., Baseline,4 weeks
Secondary Outcome Measures: Change from Baseline score of the Sunnybrook grading(SFGS) scale, The Sunnybrook grading scale includes 3 subscales, which are the resting symmetry subscale, the symmetry of voluntary movement subscale, and the synkinesis subscale. In the resting symmetry subscale, the minimal score is 0, which indicates normal resting symmetry, and the maximal score is 20, which indicates the most severe resting asymmetry. In the symmetry of voluntary movement subscale, the minimal score is 20, which indicates gross asymmetry of voluntary movement, and the maximal score is 100, which indicates normal symmetry of voluntary movement. And in the synkinesis subscale, the minimal score is 0, which indicates no involuntary muscle contraction associated with each expression, and the maximal score is 15, which indicates the most severe involuntary muscle contraction associated with each expression. The composite score equals to the symmetry of voluntary movement score minus the resting symmetry score and the synkinesis score., Baseline,4 weeks|Change from Baseline score of the Facial Disability Index(FDI), The FDI is a brief, self-report questionnaire of physical disability and psychosocial factors related to facial neuromuscular function. It was intended to assess disability and the outcome of intervention in terms of meaningful change in the patient's physical disability and psychosocial status., Baseline,4 weeks|Change from Baseline value of the amplitude ratio of the compound muscle action potential (CMAP) of the affected side in the ENoG test., Change from Baseline value of the amplitude ratio of the compound muscle action potential (CMAP) of the affected side in the ENoG test., Baseline