Clinical Study on the End Time of Acupuncture and Moxibustion Therapy for Peripheral Facial Paralysis: Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Sunnybrook(SB) score
研究概览
简要总结
Bell's palsy itself has a certain self-healing tendency. Therefore, it is recommended to leave a bit of Bell's palsy for self-recovery without treatment. If complete recovery is achieved after treatment, complications such as stiffness, contracture and even hemifacial inversion may occur as time moves. Therefore, this study aims to evaluate the optimal end time of acupuncture for facial paralysis.
详细描述
This is a randomized, double-blind, controlled study, with a total of 120 eligible patients randomly divided into an observation group (n=60) and a control group (n=60). Both groups received facial acupuncture combined with infrared irradiation treatment, once a day,10 times as a course, and the next course of treatment will be carried out after a 5-day rest.The treatment duration for both groups will not exceed three months, with the observation group aiming for a Sunnybrook score of ≥83 and the control group aiming for a score≥95. The primary outcome measure is Sunnybrook scores at 6 months after onset compared with baseline. Secondary outcome measures included Sunnybrook Scores, electroneurography, blink reflex, Facial Disability Index, Self-Rating Depression Scale and Self-Rating Anxiety Scale.
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, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients aged 18-75 years.
- •Patients diagnosed with peripheral facial paralysis≤7 days before screening and was the first time.
- •All cases have symptoms and signs or have been examined by CT, MRI, etc., excluding peripheral facial paralysis caused by central nervous system diseases, ear diseases, and trauma.
- •Those who voluntarily sign the Research Informed Consent Form
排除标准
- •Patients with bilateral facial nerve palsy or recurrent facial nerve palsy (more than two occurrences).
- •Pregnant or nursing patients.
- •Patients with critically ill which is difficult to make a definite evaluation of the efficacy and safety of treatment
- •Those who accept other treatment methods or cannot adhere to this plan, which affects the efficacy observation
结局指标
主要结局
Sunnybrook(SB) score
时间窗: Change from Baseline scores of SB score at at 6-months after onset.
This scoring was used to detect the severity of peripheral facial paralysis(PFP).Which include three parts: resting symmetry, symmetry of voluntary movement, and synkinesis. In the resting symmetry scoring of the facial nerve, "normal" in each area refers to being "symmetrical/equivalent" compared to the healthy side. The total score for facial nerve function assessment is calculated as voluntary movement score minus resting symmetry score minus synkinesis score, with a maximum score of 100.The sunnybrook scores were used to define five categories of PFP severity:Normal person（90\~100 points）;mild PFP levels（76\~89 points）;moderate PFP levels（61\~75 points）;moderate to severe PFP levels（31\~60points）;and presence of severe PFP（0\~30 points）。
次要结局
- Electroneuronography (ENoG)(Change from Baseline amplitude and potential of CAMP and the numbers of pathological ENoG at at 6、12months after onset.)
- Blink Reflex(Change from Baseline number of pathological Blink Reflex at 6、12months after onset.)
- Facial disability index (FDI)(Change from Baseline scores of FDI score at at 3、6、12months after onset.)
- Sunnybrook(SB) score(Change from Baseline scores of SB score at at 3、12months after onset.)
- Self-Rating Anxiety Scale(SAS)(Change from Baseline scores of FDI score at at 3、6、12months after onset.)
- Self-Rating Depression Scale(SDS)(Change from Baseline scores of FDI score at at 3、6、12months after onset.)