Manual Therapy in Metabolic Liver Disease | NCT06338618

Studies
Manual Therapy in Metabolic Liver Disease

NCT06338618

Sponsor

University of Seville

Status

Completed

Last Update Posted

Dec 11, 2024Actual

Enrollment

42Actual

Phase

Not Applicable

Conditions

NAFLD, Non-alcoholic Fatty Liver Disease

Interventions

liver treatment protocol

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 3, 2024Actual

Primary Completion Date

Sep 20, 2024Actual

Completion Date

Sep 20, 2024Actual

First Submitted Date

Mar 15, 2024

First Submission Date that Met QC Criteria

Mar 28, 2024

First Posted Date

Mar 29, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 5, 2024

Last Update Posted Date

Dec 11, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Angel Oliva Pascual-Vaca, Head of Physiotherapy Department, University of SevillePrincipal Investigator

Lead Sponsor

University of SevilleOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

42Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Angel Oliva Pascual-Vaca, Dr	University of Seville	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Universitary Hospital Juan Ramón Jiménez		Huelva		21005	Spain

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D065626	Non-alcoholic Fatty Liver Disease

Ancestor Terms

ID	Term
D005234	Fatty Liver
D008107	Liver Diseases
D004066	Digestive System Diseases

Browse Leaves

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Browse Branches

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