Effect of Pectoral Electrostimulation on Reduction of Mammary Ptosis
Effect of Pectoral Electrostimulation on Reduction of Mammary Ptosis After Bariatric Surgery
A prospective randomized clinical trial of patients undergoing bariatric surgery.
Patients were randomly assigned into 3 groups: those patients undergoing percutaneous electrostimulation (PENS) of the pectoral muscle combined with specific training (Group 1), those patients doing the specific training alone (Group 2) and those patients without any specific treatment (Group 3).
The assigned treatment began 15 days after surgery and was maintained during 12 weeks.
研究概览
详细说明
A prospective randomized clinical trial of patients undergoing laparoscopic sleeve gastrectomy (LSG) or laparoscopic Roux-en-Y gastric bypass (RYGB) during 2014 was performed.
Patients were randomly assigned using a random-number table into 3 groups: those patients undergoing percutaneous electrostimulation (PENS) of the pectoral muscle combined with specific training (Group 1), those patients doing the specific training alone (Group 2) and those patients without any specific treatment (Group 3).
The assigned treatment began 15 days after surgery and was maintained during 12 weeks.
研究类型
注册 (实际的)
阶段
- 第三阶段
参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- patients with body mass index (BMI) >40 Kg/m2 or BMI > 35 Kg/m2 with the presence of comorbidities associated to obesity, undergoing a bariatric procedure.
Exclusion Criteria:
- all kind of previous breast surgery.
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：PENS with training
Patients undergoing percutaneous electrostimulation (PENS) of the pectoral muscle combined with specific training during 12 weeks postoperatively
|
The participants underwent one 30-min session every week for 12 consecutive weeks.
PENS was delivered by a needle electrode inserted in the medioclavicular line, 2 cm below the clavicle at a 90° angle towards the skin at a depth of approximately 1 cm.
PENS was undertaken at frequency of 20 Hz at the highest amplify (0-20 mA) without causing pain.
PENS was delivered simultaneously in both pectoral muscles.
Patients underwent specific training exercises to improve pectoral fitness.
|
|
有源比较器：Specific training
Patients undergoing specific training during 12 weeks postoperatively
|
Patients underwent specific training exercises to improve pectoral fitness.
|
|
无干预：No intervention
No specific treatment was assigned to these patients postoperatively
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Satisfaction degree. 7-points Likert scale was used for the quantification.
大体时间：12 weeks of treatment
|
The patients were asked to quantify their satisfaction degree with the esthetic results of their breasts after the treatment.
|
12 weeks of treatment
|
合作者和调查者
调查人员
- 首席研究员：Jaime Ruiz-Tovar, MD, PhD、Hospital General Elche
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- HURJC2015-02
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
PENS的临床试验
-
Hospital General Universitario Elche完全的
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University of PittsburghNational Institute on Aging (NIA); National Center for Complementary and Integrative Health...完全的