Treatment of Electroacupuncture With Different Waveform for Subacute Peripheral Facial Paralysis:Study Protocol for a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Change from Baseline score of the Facial Nerve Grading System 2.0(FNGS 2.0)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients meet the clinical classification criteria for BP, diagnosed by specialist.
- •1-3 weeks from onset.
- •Male or female patients aged 18-65 years.
- •Clearly aware, able to complete normal communication, signed informed consent.
排除标准
- •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;.
- •Patients with Hunter's syndrome.
- •Patients with bilateral facial nerve palsy.
- •Patients with hemifacial spasm as the the main clinical symptoms.
- •Patients with severe cardiovascular and cerebrovascular diseases, liver, kidney, hematopoietic system diseases, malignant tumors and systemic organ failure, pregnant or lactating patients.
- •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.
- •Participants in other clinical trials within the last 3 months.
研究组 & 干预措施
low-frequency continuous wave group
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.
干预措施: low-frequency continuous wave EA (Other)
discontinuous wave group
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.
干预措施: discontinuous wave EA (Other)
dilatational wave group
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.
干预措施: dilatational wave EA (Other)
结局指标
主要结局
Change from Baseline score of the Facial Nerve Grading System 2.0(FNGS 2.0)
时间窗: Baseline,4 weeks
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.
次要结局
- Change from Baseline value of the amplitude ratio of the compound muscle action potential (CMAP) of the affected side in the ENoG test.(Baseline)
- Change from Baseline score of the Facial Disability Index(FDI)(Baseline,4 weeks)
- Change from Baseline score of the Sunnybrook grading(SFGS) scale(Baseline,4 weeks)
研究者
Jing Sun
Deputy director of the teaching department
The Third Affiliated hospital of Zhejiang Chinese Medical University