Manual Therapy in Metabolic Liver Disease

NCT06338618 | Completed

• 1 other identifier: 1532-N-23
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

NAFLD, Non-alcoholic Fatty Liver Disease

Outcome Measures

Primary Outcomes (1)

• Hepatic steatosis index

  Decrease in the hepatic steatosis index

  Pre-intervention. Post-intervention 4 weeks

Secondary Outcomes (6)

• FIB-4 index

  Pre-intervention. Post-intervention 4 weeks

• NAFLD-fibrosis index

  Pre-intervention. Post-intervention 4 weeks

• HOMA index

  Pre-intervention. Post-intervention 4 weeks

• TyG index

  Pre-intervention. Post-intervention. 4 weeks

• Change from baseline in algometry

  Pre-intervention Post-intervention 4 weeks

Study Arms (2)

liver treatment protocol

EXPERIMENTAL

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

placebo comparator

NO INTERVENTION

This group will not receive any type of treatment

Interventions

liver treatment protocol PROCEDURE

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

liver treatment protocol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients over 18 years of age with MetHD defined by an ultrasound compatible with hepatic steatosis and an HSI \> 36

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Seville: lead

Study Sites (1)

Universitary Hospital Juan Ramón Jiménez

Huelva, 21005, Spain

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Officials

• Angel Oliva Pascual-Vaca, Dr

  University of Seville

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Physiotherapy Department

Study Record Dates

• First Submitted: March 15, 2024
• First Posted: March 29, 2024
• Study Start: April 3, 2024
• Primary Completion: September 20, 2024
• Study Completion: September 20, 2024
• Last Updated: December 11, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)