Effects of the Low-level Laser Therapy on Inflammatory Profile on Patients With Coronary Artery Bypass Surgery: A Randomized, Controlled Clinical Trail
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 38
- 主要终点
- cytokine IL-10
研究概览
简要总结
Cardiovascular diseases are the leading causes of morbidity and mortality in Brazil and surgical procedures to treat these disorders have grown dramatically in recent years. Since the first heart surgery in successful open field in humans, conducted in 1953 by John Lewis, many techniques have been used to improve the outcome of surgery and reduce their side effects. The low-level laser therapy (LBP) has been widely used in clinical practice for pain relief purposes, reducing inflammation and stimulating tissue healing. However, the effect of this therapy has been little elucidated in patients with cardiac disease. The objective of this study is to evaluate the effect of low level laser therapy on the inflammatory profile and cardiac tissue healing markers of patients in the postoperative period of CABG surgery.
详细描述
This study will be conducing in a large hospital that is reference in Cardiovascular diseases treatments. 38 patients will be randomized for placebo or 6J low-level laser therapy (LLLT). The inflammatory profile and cardiac tissue will be assessment before and after de LLLT.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients after elective coronary artery bypass surgery, hemodynamically stable, without ischemic changes and / or complex arrhythmias on the electrocardiogram, between 45 and 75 years of age, who have performed the first surgery
排除标准
- •Patients with decompensated heart failure; other associated surgery; presence of any comorbidity such as: unstable angina; sequel of stroke; photosensitivity; use of cardiac pacemaker; Diabetes mellitus (due to the negative effect of diabetes on wound healing).
研究组 & 干预措施
0J LLLT
The intervention will be made with the machine off.
干预措施: 0J LLLT (Device)
6J LLLT
The Laser radiation will be made with 4J by spot
干预措施: 6J LLLT (Device)
结局指标
主要结局
cytokine IL-10
时间窗: six days
cytokine IL-6
时间窗: six days
cytokine TNF-α
时间窗: six days
次要结局
- Visual Analog scale(six days)
- Troponin(six days)
- Lactate dehydrogenase (LDH)(six days)
- Creatine phosphokinase (CK)(six days)
- Complete blood count(six days)
- Hospital stay(six days)
- Pulmonary complications(six days)
研究者
Rodrigo Della Méa Plentz
Clinical Research
Federal University of Health Science of Porto Alegre