NAFLD, Non-alcoholic Fatty Liver Disease
Conditions
Brief summary
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.
Detailed description
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).
Interventions
PROCEDUREliver treatment protocol
The liver treatment protocol consists of performing twelve visceral manual techniques in an approximate time of 30 minutes twice a week for 4 weeks
Sponsors
University of Seville
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients over 18 years of age with MetHD defined by an ultrasound compatible with hepatic steatosis and an HSI \> 36
Exclusion criteria
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hepatic steatosis index | Pre-intervention. Post-intervention 4 weeks | Decrease in the hepatic steatosis index |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| NAFLD-fibrosis index | Pre-intervention. Post-intervention 4 weeks | Decrease in the NAFLD-fibrosis index |
| HOMA index | Pre-intervention. Post-intervention 4 weeks | Decrease in the HMA index |
| FIB-4 index | Pre-intervention. Post-intervention 4 weeks | Decrease in the FIB-4 index |
| Change from baseline in algometry | Pre-intervention Post-intervention 4 weeks | Pressure pain threshold in face and neck tissues. PPT levels defined as the minimum necessary |
| Visual analogue Scale | Pre-intervention. Post-intervention 4 weeks | Self-perceived pain intensity |
| TyG index | Pre-intervention. Post-intervention. 4 weeks | Decrease in the TyG index |
Countries
Spain
Outcome results
None listed