NAFLD, Non-alcoholic Fatty Liver DiseaseOSTEO-EHMetNCT06338618
Manual Therapy in Metabolic Liver Disease
A study testing liver treatment protocol in people with NAFLD, Non-alcoholic Fatty Liver Disease, run by University of Seville at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NAFLD, Non-alcoholic Fatty Liver Disease
- What is being tested?
- liver treatment protocol
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteSpain
- Study dates
- 3 Apr 2024to 20 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over 18 years of age with MetHD defined by an ultrasound compatible with hepatic steatosis and an HSI > 36
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Manual Therapy Effects in Patients With Metabolic-associated Fatty 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.
Read the 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).
- Conditions
- NAFLD, Non-alcoholic Fatty Liver Disease
- Being tested
- liver treatment protocol
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
liver treatment protocolProcedure or surgery
The liver treatment protocol consists of performing twelve visceral manual techniques in an approximate time of 30 minutes twice a week for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: liver treatment protocol |
| placebo comparator | No intervention | This group will not receive any type of treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hepatic steatosis index
Decrease in the hepatic steatosis index
Measured: Pre-intervention. Post-intervention 4 weeks
Secondary outcomes (6)
FIB-4 index
Decrease in the FIB-4 index
Measured: Pre-intervention. Post-intervention 4 weeks
NAFLD-fibrosis index
Decrease in the NAFLD-fibrosis index
Measured: Pre-intervention. Post-intervention 4 weeks
HOMA index
Decrease in the HMA index
Measured: Pre-intervention. Post-intervention 4 weeks
TyG index
Decrease in the TyG index
Measured: Pre-intervention. Post-intervention. 4 weeks
Change from baseline in algometry
Pressure pain threshold in face and neck tissues. PPT levels defined as the minimum necessary
Measured: Pre-intervention Post-intervention 4 weeks
Visual analogue Scale
Self-perceived pain intensity
Measured: Pre-intervention. Post-intervention 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2024
- Study start3 Apr 2024
- Primary completion20 Sep 2024
- Study completion20 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NAFLD, Non-alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Seville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Angel Oliva Pascual-Vaca, University of Seville
- Investigators
- Angel Oliva Pascual-Vaca, Dr, Study director, University of Seville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06338618
- Sponsor's protocol ID
- 1532-N-23
- Acronym
- OSTEO-EHMet
- Status last verified
- Dec 2024
- First submitted
- 15 Mar 2024
- Last updated
- 11 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Manual Therapy Effects in Patients With Metabolic-associated Fatty Liver Disease
- ClinicalTrials.gov ID
- NCT06338618
- Acronym / sponsor ID
- OSTEO-EHMet / 1532-N-23
- Conditions
- NAFLD, Non-alcoholic Fatty Liver Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of SevilleUniversity, hospital or other
- Study start
- 3 Apr 2024 (actual)
- Primary completion
- 20 Sep 2024 (actual)
- Study completion
- 20 Sep 2024 (actual)
- First posted
- 29 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| liver treatment protocol | Experimental | Procedure: liver treatment protocolThe 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 | No intervention | –This group will not receive any type of treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients over 18 years of age with MetHD defined by an ultrasound compatible with hepatic steatosis and an HSI > 36
Key exclusion criteria (8 listed)
- Fibrosis defined by FIB-4 > 2.67
- Hepatic cirrhosis
- Geographic dispersion to avoid losses
- Contraindication to manual therapy
- Diabetes mellitus tiype 1
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| liver treatment protocolThe liver treatment protocol consists of performing twelve visceral manual techniques in an approximate time of 30 minutes twice a week for 4 weeks | Procedure or surgery | liver treatment protocol |
Primary outcome
Hepatic steatosis index
Time frame: Pre-intervention. Post-intervention 4 weeks
Decrease in the hepatic steatosis index
6 secondary outcomes
FIB-4 index
Time frame: Pre-intervention. Post-intervention 4 weeks
NAFLD-fibrosis index
Time frame: Pre-intervention. Post-intervention 4 weeks
HOMA index
Time frame: Pre-intervention. Post-intervention 4 weeks
TyG index
Time frame: Pre-intervention. Post-intervention. 4 weeks
Change from baseline in algometry
Time frame: Pre-intervention Post-intervention 4 weeks
Visual analogue Scale
Time frame: Pre-intervention. Post-intervention 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Angel Oliva Pascual-Vaca, Dr study director
University of Seville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing liver treatment protocol in people with NAFLD, Non-alcoholic Fatty Liver Disease, run by University of Seville at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hepatic steatosis index (time frame: Pre-intervention. Post-intervention 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2024.