Ignite Creation Date:
2025-12-25 @ 4:41 AM
Ignite Modification Date:
2025-12-26 @ 3:43 AM
Study NCT ID:
NCT06338618
Status:
COMPLETED
Last Update Posted:
2024-12-11
First Post:
2024-03-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Manual Therapy in Metabolic Liver Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065626', 'term': 'Non-alcoholic Fatty Liver Disease'}], 'ancestors': [{'id': 'D005234', 'term': 'Fatty Liver'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-04-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2024-09-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-05', 'studyFirstSubmitDate': '2024-03-15', 'studyFirstSubmitQcDate': '2024-03-28', 'lastUpdatePostDateStruct': {'date': '2024-12-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hepatic steatosis index', 'timeFrame': 'Pre-intervention. Post-intervention 4 weeks', 'description': 'Decrease in the hepatic steatosis index'}], 'secondaryOutcomes': [{'measure': 'FIB-4 index', 'timeFrame': 'Pre-intervention. Post-intervention 4 weeks', 'description': 'Decrease in the FIB-4 index'}, {'measure': 'NAFLD-fibrosis index', 'timeFrame': 'Pre-intervention. Post-intervention 4 weeks', 'description': 'Decrease in the NAFLD-fibrosis index'}, {'measure': 'HOMA index', 'timeFrame': 'Pre-intervention. Post-intervention 4 weeks', 'description': 'Decrease in the HMA index'}, {'measure': 'TyG index', 'timeFrame': 'Pre-intervention. Post-intervention. 4 weeks', 'description': 'Decrease in the TyG index'}, {'measure': 'Change from baseline in algometry', 'timeFrame': 'Pre-intervention Post-intervention 4 weeks', 'description': 'Pressure pain threshold in face and neck tissues. PPT levels defined as the minimum necessary'}, {'measure': 'Visual analogue Scale', 'timeFrame': 'Pre-intervention. Post-intervention 4 weeks', 'description': 'Self-perceived pain intensity'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['NAFLD, Non-alcoholic Fatty Liver Disease']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThe 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.\n\nFor 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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients over 18 years of age with MetHD defined by an ultrasound compatible with hepatic steatosis and an HSI \\> 36\n\nExclusion Criteria:\n\n* Fibrosis defined by FIB-4 \\> 2.67\n* Hepatic cirrhosis\n* Geographic dispersion to avoid losses\n* Contraindication to manual therapy\n* Diabetes mellitus tiype 1\n* Severe hypertriglyceridemia with TG \\> 500 mg/dl at the time of recruitment\n* Life expectancy less than one year\n* Advanced chronic kidney disease (stage G4)'}, 'identificationModule': {'nctId': 'NCT06338618', 'acronym': 'OSTEO-EHMet', 'briefTitle': 'Manual Therapy in Metabolic Liver Disease', 'organization': {'class': 'OTHER', 'fullName': 'University of Seville'}, 'officialTitle': 'Manual Therapy Effects in Patients With Metabolic-associated Fatty Liver Disease', 'orgStudyIdInfo': {'id': '1532-N-23'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'liver treatment protocol', 'description': 'The liver treatment protocol consists of performing twelve visceral manual techniques in an approximate time of 30 minutes twice a week for 4 weeks.', 'interventionNames': ['Procedure: liver treatment protocol']}, {'type': 'NO_INTERVENTION', 'label': 'placebo comparator', 'description': 'This group will not receive any type of treatment'}], 'interventions': [{'name': 'liver treatment protocol', 'type': 'PROCEDURE', 'description': 'The liver treatment protocol consists of performing twelve visceral manual techniques in an approximate time of 30 minutes twice a week for 4 weeks', 'armGroupLabels': ['liver treatment protocol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21005', 'city': 'Huelva', 'country': 'Spain', 'facility': 'Universitary Hospital Juan Ramón Jiménez', 'geoPoint': {'lat': 37.26638, 'lon': -6.94004}}], 'overallOfficials': [{'name': 'Angel Oliva Pascual-Vaca, Dr', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Seville'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Seville', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Physiotherapy Department', 'investigatorFullName': 'Angel Oliva Pascual-Vaca', 'investigatorAffiliation': 'University of Seville'}}}}