Clinical trial NCT06573697: EA Treatment with Different Waveform for Subacute BP:study Protocol for a Randomized Controlled Trial
Official title: Treatment of Electroacupuncture with Different Waveform for Subacute Peripheral Facial Paralysis:study Protocol for a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Bell Palsy
Keywords: Bell palsy
Peripheral facial paralysis
Clinical study
Acupuncture treatment
Lead sponsor: The Third Affiliated hospital of Zhejiang Chinese Medical University
Sponsor class: OTHER
First posted: 2024-08-27
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: This parallel-group, multicenter randomized clinical trial (RCT) will be conducted at the outpatient clinic of three hospitals in China.A total of seventy-five eligible patients will be randomly divided into low frequency continuous wave(n=25) ,discontinuous wave(n=25) and dilatational wave (n=25) groups.All groups will receive traditional acupuncture treatment at selected acupoints (BL2,GB1,GB14,ST2,SI18,ST4,ST6,ST7,SJ17,EX-HN16,EX-HN5,LI4),additionally,receive different waveform of electroacupuncture treatment for 20 minutes three times per week for four weeks.Facial Nerve Grading System 2.0 (FNGS 2.0) will be used to assess the curative effect at baseline and at 4 weeks after treatment, as the primary outcome.Sunnybrook facialgrad-ingsystem(SFGS) and Facial Disability Index (FDI)Scale will be measured and analyzed at baseline and at 4 weeks after treatment, as secondary outcomes.In addition,amplitude ratio of the affected/healthy side will be another secondary outcome tested by ENoG at bsaeline.

Eligibility criteria: Inclusion Criteria:

1. Patients meet the clinical classification criteria for BP, diagnosed by specialist.
2. 1-3 weeks from onset.
3. Male or female patients aged 18-65 years.
4. FNGS2.0≥4
5. Clearly aware, able to complete normal communication, signed informed consent.

Exclusion Criteria:

1. Facial paralysis due to other causes, such as stroke, Guillain-Barre syndrome, multiple sclerosis, encephalitis, facial nerve tumors, skin tumors, parotid tumors, and facial nerve trauma;.
2. Patients with Hunter's syndrome.
3. Patients with bilateral facial nerve palsy.
4. Patients with hemifacial spasm as the the main clinical symptoms.
5. Patients with severe cardiovascular and cerebrovascular diseases, liver, kidney, hematopoietic system diseases, malignant tumors and systemic organ failure, pregnant or lactating patients.
6. Patients with a tendency to bleed easily, who are not suitable for electroacupuncture such as installing a pacemaker, or who cannot cooperate with treatment for other reasons.
7. Participants in other clinical trials within the last 3 months.

Primary outcomes:
measure: Change from Baseline score of the Facial Nerve Grading System 2.0(FNGS 2.0)
timeFrame: Baseline,4 weeks
Secondary outcomes:
measure: Change from Baseline score of the Sunnybrook grading(SFGS) scale
timeFrame: Baseline,4 weeks
measure: Change from Baseline score of the Facial Disability Index(FDI)
timeFrame: Baseline,4 weeks
measure: Change from Baseline value of the amplitude ratio of the compound muscle action potential (CMAP) of the affected side in the ENoG test.
timeFrame: Baseline
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The Third Affiliated hospital of Zhejiang Chinese Medical University
state: Zhejiang
Study officials:
affiliation: The Third Clinical College of Zhejiang Chinese Medical University
name: Jing Sun, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: