EA Treatment With Different Waveform for Subacute BP:Study Protocol for a Randomized Controlled Trial

The Third Affiliated hospital of Zhejiang Chinese Medical University75 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Bell Palsy

Interventions

low-frequency continuous wave EAOTHER

In each treatment session, the subjects will receive EA treatment. The selected acupoints for needling will be BL2, GB1, GB14, ST2, SI18, ST6, ST4, ST7, SJ17, EX-HN16, EX-HN5, on affected side, and LI4, bilaterally. After the de-qi sensation is achieved, electrical stimulator will be connected to BL2-GB1, and ST4-ST6, and 2Hz continuous wave will be used for 20 min.

discontinuous wave EAOTHER

dilatational wave EA

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

The Third Affiliated hospital of Zhejiang Chinese Medical University

Hangzhou, Zhejiang, China

Outcomes

Primary Outcomes

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.

Time frame: Baseline,4 weeks

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

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