Manual Therapy in Metabolic Liver Disease

Not Applicable

Completed

• Conditions: NAFLD, Non-alcoholic Fatty Liver Disease
• Interventions: Procedure: liver treatment protocol

• Registration Number: NCT06338618
• Lead Sponsor: University of Seville

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).

Study Timeline

• Study First Submitted: 2024-03-15
• Study First Submitted QC: 2024-03-28
• Study First Posted: 2024-03-29
• Study Start: 2024-04-03
• Primary Completion: 2024-09-20
• Study Completion: 2024-09-20
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-05
• Last Update Posted: 2024-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
liver treatment protocol	liver 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.

Primary Outcome Measures

Name	Time	Method
Hepatic steatosis index	Pre-intervention. Post-intervention 4 weeks	Decrease in the hepatic steatosis index

Secondary Outcome Measures

Name	Time	Method
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
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
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

Trial Locations

Locations (1)

Universitary Hospital Juan Ramón Jiménez; 🇪🇸 Huelva, Spain