Study of Effects of Deqi and Neuropsychological Factors on Acupuncture Effects in Treatment of Bell's Palsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 355
- 试验地点
- 1
- 主要终点
- House-Brackmann scale (HBS)
研究概览
简要总结
The purpose of this study is to observe the influence of Deqi and neuropsychological factors on effects of acupuncture treatment for Bell's Palsy.
详细描述
Through long-term clinical practice，acupuncture treatment on facial paralysis has been generally proved effective；the large number of ancient and modern medical literature also have suggested that acupuncture is beneficial for facial paralysis. However,a scientific basis is still needed to be established to make sure the efficacy of acupuncture be recognized internationally.This study will adopt a series of international practice scales ,such as House Brackmann Scale,Facial Disability Index(FDI),World Health Organization Quality of Life-BREF (WHOQOL-BREF), Cattell Personality Factors (16PF),and Cancellation test to evaluate the role of deqi and neuropsychological factors in the acupuncture treatment for Bell's Palsy.
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
- Double (Participant, 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 who were diagnosed to have unilateral facial-nerve weakness without any identifiable causes within 168 hours after onset of symptoms;
- •aged 18 to 65 years.
排除标准
- •illiterate;
- •the facial paralysis is caused by herpes zoster;
- •recurrent facial paralysis;
- •noticeable asymmetry of the face before the illness which may affect the evaluation;
- •history of peptic ulcer disease, severe hypertension, uncontrolled diabetes, liver and kidney dysfunction, pregnancy, mental illness, or serious systemic diseases which may affect the treatment.
研究组 & 干预措施
Acupuncture with Deqi
Needles were inserted and manipulated manually using the techniques such as lifting, thrusting, and twirling, until the internal compound sensation of soreness, numbness, fullness, aching, cool, warmth, heaviness and radiating sensation (Deqi) occurred. The needles were retained for 30 min.
干预措施: acupuncture, deqi (Device)
Acupuncture without Deqi
Needles were simply inserted and retained for 30 min, without any other stimulation.
干预措施: acupuncture Non-manipulation (Device)
结局指标
主要结局
House-Brackmann scale (HBS)
时间窗: 6 months after onset of symptoms
次要结局
- facial disability index (FDI)(6 months after onset of symptoms)
- World Health Organization Quality of Life-BREF(WHOQOL-BREF)(6 months after onset of symptoms)
研究者
Wei Wang
Department of Neurology of Tongji Hospital
Huazhong University of Science and Technology