Effect of transcutaneous electrical nerve stimulation of T6 dermatome on appetite and weight reduction in obese individuals: a pilot study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- 1. Appetite level: A visual analogue scale (VAS) will be used to measure the appetite level. The scale is caliberated from 0 to 100 with mm interval. VAS (0mm) is considered as "not at all hungry and (100 mm) is "as hungry as I have ever felt". The other side of the scale with marking only 0 and 100 will be shown to subjects and they will mark their current appetite level.
研究概览
简要总结
This will be a open label pilot study aimed to find the effect of transcutaneous electrical nerve stimulation of T6 dermatome on appetite and weight loss in obese individuals. Interventions will be carried out once a week and for 12 weeks. The outcome measures will be level of appetite on visual analogue scale, weight and BMI evaluated before intervention, on each intervention day and 8 weeks after final treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •BMI > 30 kg/m2
- •Appetite level on VAS ≥ 3
- •Dietary treatment failure.
排除标准
- •Any known endocrine disease resulting in obesity
- •Evidence of metabolic, neurological, psychiatric, gynecological and cardiovascular disorders
- •Any evidence of infection or malignant conditions
- •Previous abdominal surgeries
- •Withdrawal of consent.
结局指标
主要结局
1. Appetite level: A visual analogue scale (VAS) will be used to measure the appetite level. The scale is caliberated from 0 to 100 with mm interval. VAS (0mm) is considered as "not at all hungry and (100 mm) is "as hungry as I have ever felt". The other side of the scale with marking only 0 and 100 will be shown to subjects and they will mark their current appetite level.
时间窗: 1. Baseline | 2. on each intervention session | 3. 8 weeks after the final intervetion
次要结局
- 1. Weight will be measured by caliberated standardized weigh machine.(2. BMI: After weight and height measurement by measuring tools,BMI will be calculated.)