A Pilot study comparing needle Electromyographic guidance vs. conventional blind method of injecting Botulinum Toxin A for treating upper face dynamic rhytides
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 1. Dermatology Life Quality Index Score System.
研究概览
简要总结
This Pilot RCT compares 2 methods of injecting Botulinum Toxin A for treating upper face dynamic wrinkles.
In this study, 1 arm will undergo BoT A injection by the conventional blind method. The second arm will undergo BoTA injection with Needle EMG guidance.
We will record the Efficacy and complications in these 2 groups of patients and compare the results.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 26.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects with Upper face wrinkles who want correction
- •Subjects with dominant glabellar lines with an angry facial expression even in a relaxed state.
- •These subjects want to eliminate the angry facial expression.
排除标准
- •Co-morbidities like hypertension, diabetes mellitus, collagen vascular disorders and autoimmune disorders.
- •Subjects with muscular dystrophy syndrome
- •Pregnant and lactating mothers.
结局指标
主要结局
1. Dermatology Life Quality Index Score System.
时间窗: baseline-at the time of intervention. At 2 weeks, 3 months, and 6 months after the procedure.
2. EMG Readings to look for the efficacy of the Botulinum toxin:
时间窗: baseline-at the time of intervention. At 2 weeks, 3 months, and 6 months after the procedure.
A) RMS : Root Mean square of bin of contraction, with 100ms envelope window
时间窗: baseline-at the time of intervention. At 2 weeks, 3 months, and 6 months after the procedure.
B) MVIC: Maximum voluntary isometric contraction
时间窗: baseline-at the time of intervention. At 2 weeks, 3 months, and 6 months after the procedure.
C) SNR:Signal to Noise ratio
时间窗: baseline-at the time of intervention. At 2 weeks, 3 months, and 6 months after the procedure.
D) Integral absolute value : Time domain assessement
时间窗: baseline-at the time of intervention. At 2 weeks, 3 months, and 6 months after the procedure.
E) MDF:Median power frequency
时间窗: baseline-at the time of intervention. At 2 weeks, 3 months, and 6 months after the procedure.
F) Inertial measurement: Accelerometer, Gyrometer.
时间窗: baseline-at the time of intervention. At 2 weeks, 3 months, and 6 months after the procedure.
次要结局
- The complications are noted in the subjects undergoing these procedures.(The compications are ptosis of the eyelid or eyebrow, eyebrow asymmetry, diplopia, lagophthalmos, palpebral ectropion, & prominence of the palpebral bags.)
研究者
Badamutlang Dympep
NEIGRIHMS