Manual Therapy in Metabolic Liver Disease

NAFLD, Non-alcoholic Fatty Liver Disease Clinical Trial

— OSTEO-EHMet  

Official title:

Manual Therapy Effects in Patients With Metabolic-associated Fatty Liver Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06338618
• Other study ID #: 1532-N-23
• Status: Recruiting
• Phase: N/A
• Start date: April 3, 2024
• Est. completion date: August 2024

Study information

• Verified date: April 2024
• Source: University of Seville
• Contact: Javier Carrasco Sánchez, Dr
• Phone: 682289772
• Email: fjcarrascos[@]icloud.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. completion date: August 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• NAFLD, Non-alcoholic Fatty Liver Disease
• Non-alcoholic Fatty Liver Disease

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
Spain	Universitary Hospital Juan Ramón Jiménez	Huelva

Sponsors (1)

Lead Sponsor	Collaborator
University of Seville

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hepatic steatosis index	Decrease in the hepatic steatosis index	Pre-intervention. Post-intervention 4 weeks
Secondary	FIB-4 index	Decrease in the FIB-4 index	Pre-intervention. Post-intervention 4 weeks
Secondary	NAFLD-fibrosis index	Decrease in the NAFLD-fibrosis index	Pre-intervention. Post-intervention 4 weeks
Secondary	HOMA index	Decrease in the HMA index	Pre-intervention. Post-intervention 4 weeks
Secondary	TyG index	Decrease in the TyG index	Pre-intervention. Post-intervention. 4 weeks
Secondary	Change from baseline in algometry	Pressure pain threshold in face and neck tissues. PPT levels defined as the minimum necessary	Pre-intervention Post-intervention 4 weeks
Secondary	Visual analogue Scale	Self-perceived pain intensity	Pre-intervention. Post-intervention 4 weeks