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Manual Therapy in Metabolic Liver Disease

NCT ID: NCT06338618

Last Updated: 2024-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-03

Study Completion Date

2024-09-20

Brief Summary

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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

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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).

Conditions

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NAFLD, Non-alcoholic Fatty Liver Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

liver treatment protocol

Intervention Type 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

placebo comparator

This group will not receive any type of treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Seville

OTHER

Sponsor Role lead

Responsible Party

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Angel Oliva Pascual-Vaca

Head of Physiotherapy Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Angel Oliva Pascual-Vaca, Dr

Role: STUDY_DIRECTOR

University of Seville

Locations

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Universitary Hospital Juan Ramón Jiménez

Huelva, , Spain

Site Status

Countries

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Spain

Other Identifiers

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1532-N-23

Identifier Type: -

Identifier Source: org_study_id