Global Osteopathic Treatment for Patients With NAFLD

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-31

Study Completion Date

2018-05-31

Brief Summary

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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.

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Detailed Description

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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

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Non-Alcoholic Fatty Liver Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Since this study does not involve a sham treatment, the researcher and Dr. Peltekian have decided to have two consent forms. Patients will be assigned a code number and will be divided randomly into treatment or non-treatment groups via Dr. Peltekian opening up sealed envelops made by researcher Jenna Wilcox. Part one of the study will involve Dr. Peltekian asking potential participants consent to be a part of a study measuring " Quality of life and readiness for management of NAFLD". Upon consent, he/she will fill out the two questionnaires and give consent that their routine blood work can be analysed anonymously. During the same time, Dr. Peltekian will open up a sealed envelope revealing a code number and either an invitation to Part 2 of the study or not to invite and to remain as a control participant. By using this method the control group is not informed of the osteopathic research of the study (Part 2), thus reducing bias.

Study Groups

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Treatment group

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.

Group Type EXPERIMENTAL

Global Osteopathic Treatment

Intervention Type OTHER

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.

Control Group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Global Osteopathic Treatment

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.

Intervention Type OTHER

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No