Clinical Trials
Lymphoedema Low Level Laser Clinical Trials
Flinders Medical Centre in South Australia has conducted the only randomised double blind clinical trial for any lymphoedema treatement in the world. The study has been published in the very reputable journal "Cancer" (2003 edition).
In the trials, 31% of patients had a reduction in limb volume of 200mls or more. This is a significant improvement.
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More importantly (for patients) this improvement was maintained for 3 months. The patients had no other treatment, yet continued to improve over the three month follow-up period.
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The results suggest a systemic effect of LTU- 904H therapy.
For an in depth description and overview of the randomised double blind clinical trials in the treatment of mastectomy lymphoedema and additional information please follow the links:
FDA Clears Laser-Based Lymphedema Therapy
The Food and Drug Administration (FDA) has cleared the RianCorp LTU-904 low-level laser device as an additional weapon in the battle for better quality of life for people living with lymphoedema.
After a four-year evaluation, the FDA cleared the LTU-904 for use as part of a therapy regime to treat post-mastectomy lymphoedema. FDA clearance permits therapists throughout the USA to use the hand- held battery-powered device to treat a patient with lymphoedema.
Since 2000, therapists in Australia have used the LTU-904 to treat patients with lymphoedema.
The FDA noted that the RianCorp LTU-904 laser therapy unit has been evaluated in a placebo-controlled double blind clinical trial of post-mastectomy lymphoedema patients in Australia.
Conducted under ethics committee approval by Flinders University, the study is the world’s only randomized double blind study of a physical treatment for post-mastectomy lymphoedema. The Flinders research team is internationally recognized in the area of lymphology and lymphoedema treatment.