Manual Therapy in Metabolic Liver Disease (OSTEO-EHMet)

University of Seville

Status: Completed

Conditions: NAFLD, Non-alcoholic Fatty Liver Disease

Treatments: Procedure: liver treatment protocol

Study type: Interventional

Funder types: Other

Identifiers

NCT06338618

1532-N-23

Details and patient eligibility

About

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.

Full 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).

Enrollment: 42 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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42 participants in 2 patient groups

liver treatment protocol

Experimental group

Description:

The liver treatment protocol consists of performing twelve visceral manual techniques in an approximate time of 30 minutes twice a week for 4 weeks.

Treatment:

Procedure: liver treatment protocol

placebo comparator

No Intervention group

Description:

This group will not receive any type of treatment