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Chi Machine Clinical Trials for Lymphedema.

Flinders University Australia
Flinder's Medical University, Adelaide, Australia, the host of the HTE's Sun Ancon Chi Machine clinical trials for Secondary Lymphedema and Venous Edema, conducted by Professor Piller.
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Lymphedema
(also spelt lymphoedema) is the accumulation of lymphatic fluid in tissues, that thereby causes swelling due to the inability of the lymphatic system to drain the excess fluids.


Secondary Lymphedema
usually develops when lymphatic vessels are damaged as a result of radiation, infection, trauma, hip or knee surgery, blood clots, long term circulatory problems or surgical removal.


Secondary lymphedema frequently develops when the lymphatic system is damaged or disrupted through cancer surgery, radiation therapy, chemotherapy, lymph node dissection or lymph node biopsy.

Traditional western medical protocols for cancer have created the single leading cause of secondary lymphedema. Invasive procedures that involve the removal of cancer - such as prostate, colon, uterus, bladder, breast and malignant melanoma - create the most likely possibility of secondary lymphedema development, due to the removal and damage done to lymph nodes.

Excess weight creates a high risk for the development of secondary lymphedema due to the flow of lymph being blocked by fat.

Secondary lymphedema occurs most often in the arms and legs, and sometimes in other parts of the body. It may occur immediately after invasive procedures or within a few weeks, months, sometimes years later.

Venous Edema
(also spelt Venous Oedema) develops due to venous insufficiency. Venous insufficiency  is caused by vascular disease, the prevalence of varicose veins, or previous deep vein thrombosis (inactive), which develops as a result of high blood pressure or if the heart is not working properly.

Insufficient blood flow in the veins of the legs, resulting from prolonged physical inactivity, trauma or blood clots will also cause venous insufficiency. When venous insufficiency takes place, excess fluids cannot be efficiently removed through the veins thereby leading to leakage into the tissues.

This then creates swelling in the affected limb - known as venous edema - tingling, cramps, varicose veins and skin pigmentation. If severe and extreme, ulcers and skin wasting may begin to occur.

Secondary Lymphedema of the legs effects 30% of people after having received invasive procedures. Venous Edema effects 5% of the adult population. Both result in swelling, discomfort and can interfere with quality of life. Conventional treatment is expensive and ongoing, with little patient control. There is no great end result for either condition.

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Clinical Trials
Sun Ancon Chi Machine:


On 15th June 2000, a contract between HTE (Hsin Ten Enterprise) Australia and Flinders University, Adelaide - part of Australia's Department of Health, Faculty of Health Sciences School of Medicine - was officially signed, that began a research project into the benefits of the Sun Ancon Chi Machine, especially for those suffering from secondary lymphedema and venous edema.

Professor Neil Piller headed the clinical trials with the support of his professional team. Professor Piller is one of the worlds leading lymphologists, who has presented and published over 300 works and is strongly committed to education and awareness programs.

Professor Piller was assisted by a team of highly professional people during the clinical trial including: Ms Amanda Moseley (Research Officer) - Mr Adrian Esterman (Bio-statistician and Clinical Epidemiologist) Associate Professor Colin Carati (Anatomist) - Mr Brian Bridger (Bio-medical Engineer) Dr Jack Walsh (Vascular Surgeon) - Dr Stephen Birrell (Surgeon).

The goal of the study was to find and test the effectiveness of a treatment that would be convenient, affordable, effective and able to empower sufferers.
Venous edema patients:
The participants were both male and female with an average age of 59 years. Over 50% of them had problems in both legs due to varicose veins, vascular disease and previous (not active) deep vein thrombosis.

Secondary lymphedema patients:
The participants were both male and female, their lymphedema being predominantly caused through cancer surgery related to bowel, cervical, prostate or melanoma. Over 45% had lymphedema in both legs.

Both groups generally continued other treatments at the same time such as support stockings, massage therapy, laser therapy and simple elevation.


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Clinical trial preparation:


a) Patients were recruited through advertising and out-patient clinics.

b) Trial included 20 normal participants.

c) Machines were taken home and used for 3 weeks using the following regime:

- Days 1-2: 5 mins - am and pm.
- Days 3-7: 8 mins - am and pm.
- Days 8-21: 12 mins - am and pm.

d) Weekly objective measurements were taken and 1 month follow up post treatment.

Some 2,000 data bits were collected from each patient at each visit, before, during and after.

What measurements were taken and how:

a) Questionnaires: Assessed how the legs felt and impact on quality of life.

b) Tonometry: Assessed tissue hardness.

c) Perometry: Assessed leg circumference and fluid volume.

d) Bioimpedence: Assessed body composition and fluid within the legs.

e) Lymphoscintigraphy: Assessed lymphatic system function.

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Results for people with
no medical problems:


Research.

Professor Neil Piller with Amanda Moseley at Flinders University, Australia, showing a clinical trial participant with Secondary Lymphedema how to use the Sun Ancon Chi Machine.

1. A reduction in fluids to the limbs.
The group with normal healthy legs experienced a reduction of 45mls in fluids over the 3 week period.

2. A reduction in weight.
The group with normal healthy legs lost an average of 0.6kg over three weeks. This is a significant amount over such a small period.

3. A reduction in percentage body fat.

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Clinical Trial Results:

Results for people with Secondary Lymphedema due to lymph damage and those with Venous Edema through venous insufficiency.

1. A significant reduction in limb volume and circumference. Extra-cellular fluid for the group with secondary lymphedema fell over the three week period. At the one month follow up the fluids had risen but were not back to their original levels.

2. A significant loss of edema fluid from the limbs. The group with venous edema experienced a reduction of 440mls in leg fluid over the three week period. Although fluid levels had increased at the one month follow up, they were not back to their original levels.

3. A significant loss of weight. Average weight loss for the group with venous edema was 1.45 kgs over the three week period. This remained stable at the one month follow up. Of those with secondary lymphedema, average weight loss was 0.5kgs and this remained stable at the one month follow up.

4. A reduction in percentage body fat.

5. An improvement in lymphatic drainage. Lymphoscintigraphy showed a marked improvement in lymphatic function.

6. A significant improvement in subjective symptoms. Most participants reported a reduction in pain, tightness, heaviness, skin dryness, limb size difference, cramps, pins and needles, burning feeling and temperature difference.

7. A satisfaction with the treatment and an improvement in the quality of life. 88% of participants were satisfied with the treatment regime. There were definite improvements with the feeling of control participants had over their condition, their range of movement, the positive impact they experienced with daily life, and an increase in their ability to exercise.

Research significance:
After analyzing the complete data it is the conclusion of Professor Piller and Flinders Medical University that used on a frequent basis, the Sun Ancon Chi Machine has great potential in health maintenance and management for those who suffer from Secondary Lymphedema and Venous Edema of the legs.

Considering the high cost of traditional treatments for secondary lymphedema and venous edema, the Chi Machine is a cheap, effective and convenient alternative.

For people without any such physical conditions, the Sun Ancon Chi Machine offers a way to aid in weight loss without the need to pay for gym memberships or to undertake impractical or strenuous exercise regimes which may cause stress or injury.

Many other parameters were also measured included blood flow, lymphatic transport capacity and immune system function.

Conclusion:
The extensive research undertaken by Flinders University Australia illustrates the commitment Hsin Ten has to the customer. This groundbreaking research has separated Hsin Ten and the Sun Ancon Chi Machine from companies producing imitation machines.

1. The Sun Ancon Chi Machine is the ONLY Chi Machine to be supported by high quality scientific and medical research.

2. Never before (or since), has any university actually endorsed a product like this.

3. Benefits were experienced by everyone, not just secondary lymphedema and venous edema patients.

3a Feedback and Results from participants and other users.

Book.

Clinical Trial Booklets -  
English, Chinese or German.

4. Flinders University Australia has independently produced 3 booklets detailing the research findings and outlining the conditions of a) Secondary Lymphedema b) Venous Edema c) Patient follow-up feedback.

5. The Sun Ancon Chi Machine was recognized as a medical device by the Australian Therapeutic Goods Administration based on the strength of the research results, as well as in Japan and Canada.

6. NO Imitation Chi Machine can claim the same benefits as the original, the Sun Ancon Chi Machine as outlined in the research findings.


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Flinders University References:

New deal sees Flinders team conduct
clinical trials for Taiwanese company.
- Flinders.edu.au - oc12v09s01

Equipment trials come up trumps.
- Flinders.edu.au - oc04v11s04

PubMed:

In-depth Medical Research Study
Scientific Basis for the Activation Properties
of the Chi Machine PDF.

- PubMed - PMID 15328757
The Sun Ancon Chi Machine Aerobic Exerciser: a new patient focused, home based therapy for people with chronic secondary leg lymphedema.

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