Effect of Transcutaneous Electro-stimulation in Ambulatory Postoperative Rehabilitation Treatment in Thoracic Surgery: Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 111
- 试验地点
- 2
- 主要终点
- Spirometry
研究概览
简要总结
Chest pain is one of the most difficult problems to solve after thoracic surgery. Its correct control is often quite difficult, which can cause complications due to an ineffective cough and superficial respiratory movements. It could provoke secretion retention, lung atelectasis, and even pneumonia. In addition, insufficient treatment of postoperative pain also causes a slower recovery of mobility, delaying the incorporation to daily life activities.
Transcutaneous electrical stimulation (TENS) is a technique that attempts to establish pain control by applying electrical current through superficial electrodes Is transcutaneous electrical nerve stimulation effective for the pain rehabilitation approach after thoracic surgery? Are there spirometry changes related to pulmonary function after the application of transcutaneous electrical nerve stimulation in postoperative rehabilitation of thoracic surgical patients?
详细描述
All patients likely to be part of the study will have an exhaustive medical history. Said clinical history will have, as a basis, the following aspects:
- Filiation data.
- Personal history.
- Type of intervention carried out.
- Incisions made.
- Chronology, location and characteristics of pain. Once intervened, the data corresponding to the surgical intervention performed will be collected. Once the period of 7 days after the intervention has passed and in the absence of complications and pleural drainage, the period of respiratory physiotherapy will begin.
Assessment of quality of life The SF-36 (Short Form Health Survey) health questionnaire will be carried out. This questionnaire is used in medical and mental health research and, in general, in health-related research. It offers an overview of the health status of the person, with the advantage that it is quick and easy to fill out, while also being easy to assess. In the same way, by allowing the numerical assessment of different aspects of the health of the person, it becomes an excellent tool for any research related to health. It contains 36 questions that address different aspects related to the daily life of the person who fills in the questionnaire. These questions are grouped and measured in 8 sections that are evaluated independently and give rise to 8 dimensions that the questionnaire measures.
The eight dimensions are:
- Physical functioning.
- Limitation due to physical problems.
- Body pain.
- Functioning or social role.
- Mental health.
- Limitation due to emotional problems.
- Vitality, energy or fatigue.
- General perception of health. In 1991, the project known as "International Quality of Life Assessment" (International Quality of Life Assessment Project, IQOLA) was started, which basically consists of adapting and testing the intercultural applicability of a generic instrument called the SF-Health Survey. (Short Form 36 Health Survey).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The principal investigator and the patient do not know which technique will be applied. The principal investigator and the patients do not know which group they are in, intervention, placebo or control.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed the informed consent.
- •Affected by pulmonary or mediastinal pathology.
- •Who have required thoracic surgery.
排除标准
- •Patients with pacemakers.
- •Diseases with chronic need for analgesic drug.
- •History of drug addiction.
- •Patients who do not require hospital readmission after surgery.
结局指标
主要结局
Spirometry
时间窗: Six month
It will consist of a simple spirometry using the Datospir Micro Sibelmed spirometer. The values of the forced vital capacity (FVC) and the volume expired forged in the first second (FEV1) are shown in percentages according to the theoretical values
McGill Test
时间窗: Six month
A McGill test will be performed to analyze the level of immediate postoperative pain. The McGill test (Painting Classification Index) (PRI) measures three dimensions: sensory, affective, and evaluative. It consists of 66 words (pain descriptors).
Quality of life survey sf-36
时间窗: Six month
The SF-36 Questionnaire is one of the most used and evaluated Health-Related Quality of Life (HRQOL) instruments.
次要结局
未报告次要终点
研究者
Daniel David Álamo Arce
Physical Therapy
University of Las Palmas de Gran Canaria