Non-Alcoholic Fatty Liver DiseaseNCT03156881
Global Osteopathic Treatment for Patients With NAFLD
A study testing Global Osteopathic Treatment in people with Non-Alcoholic Fatty Liver Disease, run by Jenna Wilcox.
Trial summary
Non-alcoholic fatty liver disease is a complex disease that is growing more prominent around the world especially in North America because of high prevalence of overweightness and obesity. There are many factors that are associated with this illness and it does not seem to be the same in every patient. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Non-Alcoholic Fatty Liver Disease
- What is being tested?
- Global Osteopathic Treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- Jul 2017to May 2018
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Has a confirmed NAFLD diagnosis from Dr. Peltekian.
- Patient is abstaining from alcohol or consuming less than 20 g/day.
- Patient is willing to improve their lifestyle, diet and increase exercise.
- Patient can comprehend English for signing of consent forms.
- Agrees to abstain from any other type of manual therapy besides the researcher's osteopathic treatment during the study period.
Who cannot join
- Any other forms of liver disease. --> The current researcher is interested in a specific liver disease, NAFLD.
- Any tumors/cancer.--> The researcher does not want to interfere with cancer treatments. As well as the focus of this study is specifically how osteopathy can help patients with NAFLD, not patients with NAFLD plus cancer (more variables to deal with here).
- Patients with any psychiatric issues or dementia.--> Need proper consent to be able to do the study. Also participants need to be able to remember and compare the difference in how they truly feel before and after treatments on their quality of life that is being measured.
- Aneurysms/thrombosis. --> The researcher will be doing manual therapy on the body and is planning on working on the fluid/lymph level at times to decrease inflammation. The researcher wants the patient to be safe.
- Any patient abusing alcohol or any illicit drugs. --> The study is on NON-alcoholic fatty liver disease...not alcoholic.
- Any cardiovascular disease and Type 1 diabetes. --> Again researcher is trying to focus on the one liver disease NAFLD.
- Extremely high levels of Y glutamyltransferase (GGT): Normal range is: 8 to 65 U/L for adults. --> This will help to differentiate between NAFLD and alcoholic fatty liver disease.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Global Osteopathic Treatment for Patients With Non-Alcoholic Fatty Liver Disease
Non-alcoholic fatty liver disease is a complex disease that is growing more prominent around the world especially in North America because of high prevalence of overweightness and obesity. There are many factors that are associated with this illness and it does not seem to be the same in every patient. The progression of this disease can with time lead to liver cirrhosis and even primary liver cancer (hepatocellular carcinoma). Currently, the only treatment plan involves diet change and exercise.
The goal of this research is to validate that Osteopathy can optimise patient health and to potentially be another option in preventing/reducing progression of this disease. This research is important for the future of Osteopathy to educate the public and other therapists/physicians the benefits this manual therapy has to offer. Previous research has been done and shown that Osteopathy can help patients with low back pain and type two diabetes, by affecting glucose and insulin levels with manipulation of the spine and pancreas.
Another study compared one group of obese patients with chronic low back pain that just did specific exercises to another group that were given exercises as well as Osteopathic manual therapy (OMT). Results showed both groups had reduced pain, however only the group with additional OMT showed improved range of motion in the thoracic spine, and showed greater degree of improvement overall for these patients. This study shows how OMT can be effective for individuals with NAFLD for in general these patients are obese and part of their treatment regime is to exercise to lose weight. The researcher could not find any previous research on OMT contributing to weight loss, however according to the Reve Pavilion natural health clinic website (2015), OMT can improve underlying issues such as low back pain, preventing the person to exercise effectively. The researcher also hopes to gain further knowledge of this subject, and to show the benefits of collaborating Osteopathy and Allopathic medicine together to obtain optimal patient care.
Read the detailed description
Randomized Quantitative Clinical Trial. There will be 48 participants randomly assigned codes numbers and placed into a treatment group or non treatment group with 24 candidates in each. The control group will not be receiving treatments whereas the experimental group will be receiving four global osteopathic treatment over a six week period. All participants in both groups will have a baseline blood work provided by Dr. Peltekian a month before commencement of treatment. These patients have routine blood work every three months to begin with so they will get their second bloodwork done after the treatment sessions.
Each group will also fill out the Chronic liver disease questionnaire to measure quality of life and the URICA to measure their readiness to change a week before the first treatment, and a week after the last treatment session.
The study objectives is to observe a difference between blood work pre and post treatment that osteopathy has influenced and improved liver function based on liver enzyme count. Also to observe an improvement in the patients quality of life after receiving treatment and in their readiness to change. The researcher hopes to validate osteopathy as another treatment option to give NAFLD patients.
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Being tested
- Global Osteopathic Treatment
- 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.
Global Osteopathic TreatmentOther
The study objectives is to observe a difference and improvement of liver function based on liver enzyme count from blood work after osteopathic treatments. Also to observe an improvement in the patients quality of life after receiving treatment and in their readiness to change.
Osteopathy is a type of manual therapy that uses gentle manipulations taking into consideration of the whole person when treating. For example if the liver is being treated, osteopaths look for mobility, to carry out its proper function. However one will also assess its interrelationships that can influence the liver such as its neighbours, articulating structures, example the diaphragm as well as its neurological input from T5-T9 for instance.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | The participants in the treatment group (anticipating 24) will be receiving four global osteopathic treatments in a six week period alongside their standard care. Their standard care is to improve diet and increase exercise.Blood work done about every 3 months to check liver enzyme levels to observe improvements or monitor severity of the disease.
This group will also complete questionnaires evaluating their quality of life (CLDQ) and their readiness to change before and after the treatment series. Receives: Other: Global Osteopathic Treatment |
| Control Group | No intervention | This group will have an anticipated 24 participants and will continue their standard care as explained above along with completing two questionnaires evaluating their quality of life and readiness to change. This group will not be receiving any osteopathic treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global osteopathic treatment will improve liver function in patient's with non-alcoholic fatty liver disease.
Baseline blood work will be taken by Dr.Peltekian prior to commencement of treatments a month beforehand. Four osteopathic treatments will be given within a 6 week period. Then another blood sample will be given by Dr. Peltekian used to compare the differences from the baseline. The researcher will observe any change in liver enzymes, blood count, triacylgylceride levels from the previous blood work and with the control groups. The goal is to see an improvement of liver function from osteopathic treatments.
Measured: 6 weeks to complete treatment series. Approximately 12 weeks to receive all relative information to assess.
Global osteopathic treatment will increase quality of life in patients with non-alcoholic fatty liver disease.
A Chronic Liver Disease Questionnaire( CLDQ) will be given to both control and treatment groups at the very beginning of the study ( first visit with Dr. Peltekian) and after the treatment series when getting their second blood work. The chronic liver disease questionnaire will be used and measured by Beth Bruce (statistician in Halifax Nova Scotia) using the Analysis of Variance. Data will be analyzed to detect differences over time, between groups and to determine if groups behave differently over time with respect to measures of quality of life. (ANOVA).
Measured: Approximately 12 weeks.
Global osteopathic treatment will increase readiness to change in patients with Non-Alcohoic Fatty Liver Disease using the URICA questionnaire.
The University Rhode Island Change Assessment Scale(URICA) will be used to measure each patient's readiness to change ( to improve diet and exercise) in both groups. It will be given twice, a month before and after treatment series to see if osteopathic treatments will have an impact on a person's readiness to change.
Measured: Approximately 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2017
- Study startJul 2017 (estimated)
- Primary completionNov 2017 (estimated)
- Study completionMay 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Model description
- 24 participants in control group receiving no global osteopathic treatment. Just standard care, baseline blood work every three months, improving their diet and exercise. They will also complete two questionnaires to measure their quality of life and readiness to change. Experimental group will also do the above with additional four osteopathic treatments to compare the differences in quality of life and liver function in both groups.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jenna Wilcox
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jenna Wilcox, Canadian College of Osteopathy
- Investigators
- Kevork Peltekian, MD, FRCPC, Principal investigator, Division of Digestive Care & Endoscopy , Department of Medicine , Department of Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03156881
- Sponsor's protocol ID
- CCOsteopathy
- Status last verified
- May 2017
- First submitted
- 12 May 2017
- Last updated
- 17 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data sets that will be shared is anonymous blood work comparisons before and after osteopathic treatments to compare differences in a persons physiology. Also the results of the questionnaires given. Data will be only obtained if given permission from Dr.Kevork Peltekian and Jenna Wilcox.
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Global Osteopathic Treatment for Patients With Non-Alcoholic Fatty Liver Disease
- ClinicalTrials.gov ID
- NCT03156881
- Acronym / sponsor ID
- CCOsteopathy
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Jenna WilcoxUniversity, hospital or other
- Study start
- Jul 2017 (estimated)
- Primary completion
- Nov 2017 (estimated)
- Study completion
- May 2018 (estimated)
- First posted
- 17 May 2017 (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.
Non-alcoholic fatty liver disease is a complex disease that is growing more prominent around the world especially in North America because of high prevalence of overweightness and obesity. There are many factors that are associated with this illness and it does not seem to be the same in every patient. The progression of this disease can with time lead to liver cirrhosis and even primary liver cancer (hepatocellular carcinoma). Currently, the only treatment plan involves diet change and exercise.
The goal of this research is to validate that Osteopathy can optimise patient health and to potentially be another option in preventing/reducing progression of this disease. This research is important for the future of Osteopathy to educate the public and other therapists/physicians the benefits this manual therapy has to offer. Previous research has been done and shown that Osteopathy can help patients with low back pain and type two diabetes, by affecting glucose and insulin levels with manipulation of the spine and pancreas.
Another study compared one group of obese patients with chronic low back pain that just did specific exercises to another group that were given exercises as well as Osteopathic manual therapy (OMT). Results showed both groups had reduced pain, however only the group with additional OMT showed improved range of motion in the thoracic spine, and showed greater degree of improvement overall for these patients. This study shows how OMT can be effective for individuals with NAFLD for in general these patients are obese and part of their treatment regime is to exercise to lose weight. The researcher could not find any previous research on OMT contributing to weight loss, however according to the Reve Pavilion natural health clinic website (2015), OMT can improve underlying issues such as low back pain, preventing the person to exercise effectively. The researcher also hopes to gain further knowledge of this subject, and to show the benefits of collaborating Osteopathy and Allopathic medicine together to obtain optimal patient care.
Detailed description
Randomized Quantitative Clinical Trial. There will be 48 participants randomly assigned codes numbers and placed into a treatment group or non treatment group with 24 candidates in each. The control group will not be receiving treatments whereas the experimental group will be receiving four global osteopathic treatment over a six week period. All participants in both groups will have a baseline blood work provided by Dr. Peltekian a month before commencement of treatment. These patients have routine blood work every three months to begin with so they will get their second bloodwork done after the treatment sessions.
Each group will also fill out the Chronic liver disease questionnaire to measure quality of life and the URICA to measure their readiness to change a week before the first treatment, and a week after the last treatment session.
The study objectives is to observe a difference between blood work pre and post treatment that osteopathy has influenced and improved liver function based on liver enzyme count. Also to observe an improvement in the patients quality of life after receiving treatment and in their readiness to change. The researcher hopes to validate osteopathy as another treatment option to give NAFLD patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 24 participants in control group receiving no global osteopathic treatment. Just standard care, baseline blood work every three months, improving their diet and exercise. They will also complete two questionnaires to measure their quality of life and readiness to change. Experimental group will also do the above with additional four osteopathic treatments to compare the differences in quality of life and liver function in both groups.
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Other: Global Osteopathic TreatmentThe participants in the treatment group (anticipating 24) will be receiving four global osteopathic treatments in a six week period alongside their standard care. Their standard care is to improve diet and increase exercise.Blood work done about every 3 months to check liver enzyme levels to observe improvements or monitor severity of the disease. This group will also complete questionnaires evaluating their quality of life (CLDQ) and their readiness to change before and after the treatment series. |
| Control Group | No intervention | –This group will have an anticipated 24 participants and will continue their standard care as explained above along with completing two questionnaires evaluating their quality of life and readiness to change. This group will not be receiving any osteopathic treatment. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Has a confirmed NAFLD diagnosis from Dr. Peltekian.
- Patient is abstaining from alcohol or consuming less than 20 g/day.
- Patient is willing to improve their lifestyle, diet and increase exercise.
- Patient can comprehend English for signing of consent forms.
- Agrees to abstain from any other type of manual therapy besides the researcher's osteopathic treatment during the study period.
Key exclusion criteria (7 listed)
- Any other forms of liver disease. --> The current researcher is interested in a specific liver disease, NAFLD.
- Any tumors/cancer.--> The researcher does not want to interfere with cancer treatments. As well as the focus of this study is specifically how osteopathy can help patients with NAFLD, not patients with NAFLD plus cancer (more variables to deal with here).
- Patients with any psychiatric issues or dementia.--> Need proper consent to be able to do the study. Also participants need to be able to remember and compare the difference in how they truly feel before and after treatments on their quality of life that is being measured.
- Aneurysms/thrombosis. --> The researcher will be doing manual therapy on the body and is planning on working on the fluid/lymph level at times to decrease inflammation. The researcher wants the patient to be safe.
- Any patient abusing alcohol or any illicit drugs. --> The study is on NON-alcoholic fatty liver disease...not alcoholic.
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 |
|---|---|---|
| Global Osteopathic TreatmentThe study objectives is to observe a difference and improvement of liver function based on liver enzyme count from blood work after osteopathic treatments. Also to observe an improvement in the patients quality of life after receiving treatment and in their readiness to change. Osteopathy is a type of manual therapy that uses gentle manipulations taking into consideration of the whole person when treating. For example if the liver is being treated, osteopaths look for mobility, to carry out its proper function. However one will also assess its interrelationships that can influence the liver such as its neighbours, articulating structures, example the diaphragm as well as its neurological input from T5-T9 for instance. | Other | Treatment group |
Primary outcome
Global osteopathic treatment will improve liver function in patient's with non-alcoholic fatty liver disease.
Time frame: 6 weeks to complete treatment series. Approximately 12 weeks to receive all relative information to assess.
Baseline blood work will be taken by Dr.Peltekian prior to commencement of treatments a month beforehand. Four osteopathic treatments will be given within a 6 week period. Then another blood sample will be given by Dr. Peltekian used to compare the differences from the baseline. The researcher will observe any change in liver enzymes, blood count, triacylgylceride levels from the previous blood work and with the control groups. The goal is to see an improvement of liver function from osteopathic treatments.
Global osteopathic treatment will increase quality of life in patients with non-alcoholic fatty liver disease.
Time frame: Approximately 12 weeks.
A Chronic Liver Disease Questionnaire( CLDQ) will be given to both control and treatment groups at the very beginning of the study ( first visit with Dr. Peltekian) and after the treatment series when getting their second blood work. The chronic liver disease questionnaire will be used and measured by Beth Bruce (statistician in Halifax Nova Scotia) using the Analysis of Variance. Data will be analyzed to detect differences over time, between groups and to determine if groups behave differently over time with respect to measures of quality of life. (ANOVA).
Global osteopathic treatment will increase readiness to change in patients with Non-Alcohoic Fatty Liver Disease using the URICA questionnaire.
Time frame: Approximately 12 weeks.
The University Rhode Island Change Assessment Scale(URICA) will be used to measure each patient's readiness to change ( to improve diet and exercise) in both groups. It will be given twice, a month before and after treatment series to see if osteopathic treatments will have an impact on a person's readiness to change.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2017.
- Individual participant dataSharing planned: Undecided. Data sets that will be shared is anonymous blood work comparisons before and after osteopathic treatments to compare differences in a persons physiology. Also the results of the questionnaires given. Data will be only obtained if given permission from Dr.Kevork Peltekian and Jenna Wilcox.
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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.
Kevork Peltekian, MD, FRCPC principal investigator
Division of Digestive Care & Endoscopy , Department of Medicine , Department of Surgery
Questions about this trial
What is this clinical trial studying?
A study testing Global Osteopathic Treatment in people with Non-Alcoholic Fatty Liver Disease, run by Jenna Wilcox.
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 5 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 17 May 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kevork Peltekian, MD, FRCPC (902-473-7833, kevork.peltekian@nshealth.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global osteopathic treatment will improve liver function in patient's with non-alcoholic fatty liver disease. (time frame: 6 weeks to complete treatment series. Approximately 12 weeks to receive all relative information to assess.). The study lists 3 primary outcomes in all. 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 17 May 2017.