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Completed

NCT Number: NCT06338618

Manual Therapy in Metabolic 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitary Hospital Juan Ramón Jiménez

Huelva, 21005, Spain

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

Primary outcomes

  1. Hepatic steatosis index

    Time frame: Pre-intervention. Post-intervention 4 weeks

    Decrease in the hepatic steatosis index

Secondary outcomes

  1. FIB-4 index

    Time frame: Pre-intervention. Post-intervention 4 weeks

    Decrease in the FIB-4 index

  2. NAFLD-fibrosis index

    Time frame: Pre-intervention. Post-intervention 4 weeks

    Decrease in the NAFLD-fibrosis index

  3. HOMA index

    Time frame: Pre-intervention. Post-intervention 4 weeks

    Decrease in the HMA index

  4. TyG index

    Time frame: Pre-intervention. Post-intervention. 4 weeks

    Decrease in the TyG index

  5. Change from baseline in algometry

    Time frame: Pre-intervention Post-intervention 4 weeks

    Pressure pain threshold in face and neck tissues. PPT levels defined as the minimum necessary

  6. Visual analogue Scale

    Time frame: Pre-intervention. Post-intervention 4 weeks

    Self-perceived pain intensity

Sponsors and collaborators

Lead sponsor

University of Seville

Other

Registry information

Official study title

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

Acronym: OSTEO-EHMet

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Mar 29, 2024
Registry last updated
Dec 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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