Non-Alcoholic Fatty Liver Disease Clinical Trial
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.
Status | Not yet recruiting |
Enrollment | 48 |
Est. completion date | May 2018 |
Est. primary completion date | November 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Jenna Wilcox |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 6 weeks to complete treatment series. Approximately 12 weeks to receive all relative information to assess. | |
Primary | 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). | Approximately 12 weeks. | |
Primary | 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. | Approximately 12 weeks. |
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