Clinical trial NCT06338618: Manual Therapy in Metabolic Liver Disease
Official title: Manual Therapy Effects in Patients With Metabolic-associated Fatty Liver Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: NAFLD, Non-alcoholic Fatty Liver Disease
Lead sponsor: University of Seville
Sponsor class: OTHER
First posted: 2024-03-29
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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)

Primary outcomes:
measure: Hepatic steatosis index
timeFrame: Pre-intervention. Post-intervention 4 weeks
Secondary outcomes:
measure: FIB-4 index
timeFrame: Pre-intervention. Post-intervention 4 weeks
measure: NAFLD-fibrosis index
timeFrame: Pre-intervention. Post-intervention 4 weeks
measure: HOMA index
timeFrame: Pre-intervention. Post-intervention 4 weeks
measure: TyG index
timeFrame: Pre-intervention. Post-intervention. 4 weeks
measure: Change from baseline in algometry
timeFrame: Pre-intervention Post-intervention 4 weeks
measure: Visual analogue Scale
timeFrame: Pre-intervention. Post-intervention 4 weeks
Other outcomes:
Locations:
city: Huelva
country: Spain
facility: Universitary Hospital Juan Ramón Jiménez
Study officials:
affiliation: University of Seville
name: Angel Oliva Pascual-Vaca, Dr
role: STUDY_DIRECTOR
References: