EA Treatment with Different Waveform for Subacute BP:study Protocol for a Randomized Controlled Trial

The Third Affiliated hospital of Zhejiang Chinese Medical University

Status: Not yet enrolling

Conditions: Bell Palsy

Treatments: Other: discontinuous wave EA; Other: low-frequency continuous wave EA; Other: dilatational wave EA

Study type: Interventional

Funder types: Other

Identifiers

NCT06573697

GZY-ZJ-KY-23071

Details and patient eligibility

About

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.

Full 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.

Enrollment: 75 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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75 participants in 3 patient groups

low-frequency continuous wave group

Experimental group

Description:

In each treatment session, the patients 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.

Treatment:

Other: low-frequency continuous wave EA

discontinuous wave group

Experimental group

Description:

In each treatment session, the patientss 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 40Hz discontinuous wave will be used for 20 min.

Treatment:

Other: discontinuous wave EA

dilatational wave group

Experimental group

Description:

In each treatment session, the patientss 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 2/100Hz dilatational wave will be used for 20 min.

Treatment:

Other: dilatational wave EA