Manual Therapy in Metabolic Liver Disease (OSTEO-EHMet)

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

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.

Study Overview

• Status: Completed
• Conditions: NAFLD, Non-alcoholic Fatty Liver Disease
• Intervention / Treatment: Procedure: liver treatment protocol

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 Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Huelva, Spain, 21005
    • Universitary Hospital Juan Ramón Jiménez

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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
No Intervention: placebo comparator; This group will not receive any type of treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hepatic steatosis index	Decrease in the hepatic steatosis index	Pre-intervention. Post-intervention 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
FIB-4 index	Decrease in the FIB-4 index	Pre-intervention. Post-intervention 4 weeks
NAFLD-fibrosis index	Decrease in the NAFLD-fibrosis index	Pre-intervention. Post-intervention 4 weeks
HOMA index	Decrease in the HMA index	Pre-intervention. Post-intervention 4 weeks
TyG index	Decrease in the TyG index	Pre-intervention. Post-intervention. 4 weeks
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
Visual analogue Scale	Self-perceived pain intensity	Pre-intervention. Post-intervention 4 weeks

Collaborators and Investigators

• Sponsor: University of Seville
• Investigators: Study Director: Angel Oliva Pascual-Vaca, Dr, University of Seville

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2024
• Primary Completion (Actual): September 20, 2024
• Study Completion (Actual): September 20, 2024

Study Registration Dates

• First Submitted: March 15, 2024
• First Submitted That Met QC Criteria: March 28, 2024
• First Posted (Actual): March 29, 2024

Study Record Updates

• Last Update Posted (Estimated): December 11, 2024
• Last Update Submitted That Met QC Criteria: December 5, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: 1532-N-23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No