Manual Therapy Effects in Patients With Metabolic-associated Fatty Liver Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Hepatic steatosis index
研究概览
简要总结
Hepatic steatosis is a disease that is becoming more common in our society; approximately 40% of the population suffers from non-alcoholic fatty liver. The beneficial effect of manual therapy for the treatment of viscera dysfunctions such as the stomach or colon is known. The objective of this study is to demonstrate the anti-inflammatory effects of visceral manual therapy in patients with metabolic liver disease associated with non-alcoholic fatty liver.
详细描述
Chronic liver diseases such as metabolic disease associated with nonalcoholic fatty liver lead to a stiff liver due to activation of hepatic stellate cells or portal fibroblasts into matrix-producing myofibroblasts. Congested livers tend to fibrosis, while the physiological forces that the liver receives during physical activity and deep breathing could have a beneficial effect on it, favoring physiological remodeling.
The importance of the mobility of the viscera for their proper functioning is known. Likewise, the beneficial effect of physical activity on the liver is known. This physical activity includes a component of applying pressure on the liver. These pressures are also exerted during the techniques described for manual liver treatment. Although there is some evidence about the effectiveness of these manual techniques for the treatment of pain situations, the effect they could have on liver parameters is unknown.
For all these reasons, we aim to know the effect of manual liver techniques on biochemical and mechanical sensitivity parameters in subjects with Metabolic Disease Associated with Non-Alcoholic Fatty Liver (NAFLD).
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over 18 years of age with MetHD defined by an ultrasound compatible with hepatic steatosis and an HSI > 36
排除标准
- •Fibrosis defined by FIB-4 > 2.67
- •Hepatic cirrhosis
- •Geographic dispersion to avoid losses
- •Contraindication to manual therapy
- •Diabetes mellitus tiype 1
- •Severe hypertriglyceridemia with TG > 500 mg/dl at the time of recruitment
- •Life expectancy less than one year
- •Advanced chronic kidney disease (stage G4)
结局指标
主要结局
Hepatic steatosis index
时间窗: Pre-intervention. Post-intervention 4 weeks
Decrease in the hepatic steatosis index
次要结局
- NAFLD-fibrosis index(Pre-intervention. Post-intervention 4 weeks)
- Visual analogue Scale(Pre-intervention. Post-intervention 4 weeks)
- HOMA index(Pre-intervention. Post-intervention 4 weeks)
- FIB-4 index(Pre-intervention. Post-intervention 4 weeks)
- TyG index(Pre-intervention. Post-intervention. 4 weeks)
- Change from baseline in algometry(Pre-intervention Post-intervention 4 weeks)
研究者
Angel Oliva Pascual-Vaca
Head of Physiotherapy Department
University of Seville