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Alternatives to Standard Treatment of Lymphedema--Low Level Laser Therapy

Low Level Laser Therapy
There is no quick fix for lymphedema.  Unfortunately, there are, in our opinion, insufficiently researched and tested medical devices out there, which can be purchased by the patient directly from the internet, promising this quick fix.  We have the emphatic opinion of "Buyer Beware." 

For some of the same reasons that we do not endorse or recommend the Acuscope, Lymphdrainage Gas Ionization, or endorse or recommend the Low Level Laser as any type of long term effective treatment of lymphedema, we are including it here for those who have questions about its use in lymphedema. 

The studies below included very small numbers of patients, which we do not believe produced reliable evidenced-based results.

Low level laser therapy (LLLT) has been introduced into the US market for the treatment of lymphedema.

In 2006 the FDA cleared the Riancorp low level laser device for lymphedema treatment.  The Riancorp LTU-904 laser therapy units are infra-red lasers operating at a wavelength of 904 nanometers. This invisible wavelength penetrates deeply into tissue where it is absorbed by cells and converted into energy that apparently aids in reducing the swelling of post mastectomy lymphedema.  The exact mechanism of how the Low Level Laser Therapy works, or how long any improvement lasts, is unknown.

Very small studies suggest that low-level laser therapy may be effective in reducing lymphedema in a clinically meaningful way for some women. Two cycles of laser treatment were found to be effective in reducing the volume of the affected arm, extracellular fluid, and tissue hardness in approximately one-third of patients with post-mastectomy lymphedema at three months post-treatment.

We researched these studies and found the laser has been tested in one trial on 64 women with either one or two cycles, delivered by therapists, and the women were followed for 3 months. This is the placebo controlled, double blind study that was the basis for granting FDA clearance.  Unfortunately, we can not find any studies in the world literature where larger numbers of women were followed for longer periods of time.

Treatment of postmastectomy lymphedema with low-level laser therapy: a double blind, placebo-controlled trial. Carati CJ, Anderson SN, Gannon BJ, Piller NB.  Department of Anatomy, School of Medicine, Flinders University, Adelaide, South Australia, Australia. colin.carati@flinders.edu.au  BACKGROUND: The current study describes the results of a double blind, placebo-controlled, randomized, single crossover trial of the treatment of patients with postmastectomy lymphedema (PML) with low-level laser therapy (LLLT). METHODS: Participants received placebo or one cycle or two cycles of LLLT to the axillary region of their affected arm. They were monitored for reductions in affected limb volume, upper body extracellular tissue fluid distribution, dermal tonometry, and range of limb movement. RESULTS: There was no significant improvement reported immediately after any of the treatments. However, the mean affected limb volume was found to be significantly reduced at 1 month or 3 months of follow-up after 2 cycles of active laser treatment. Approximately 31% of subjects had a clinically significant reduction in the volume of their PML-affected arm (> 200 mLs) approximately 2-3 months after 2 cycles of treatment. There was no significant effect of placebo treatment, or one cycle of laser treatment, on affected limb volume. The extracellular fluid index of the affected and unaffected arms and torso were reported to be significantly reduced at 3 months after 2 cycles of laser therapy, and there was significant softening of the tissues in the affected upper arm. Treatment did not appear to improve range of movement of the affected arm. CONCLUSIONS: Two cycles of laser treatment were found to be effective in reducing the volume of the affected arm, extracellular fluid, and tissue hardness in approximately 33% of patients with postmastectomy lymphedema at 3 months after treatment. Copyright 2003 American Cancer Society.DOI 10.1002/cncr.11641

We have found another study where it was tested on ten woman:

Treatment of chronic postmastectomy lymphedema with low level laser therapy: a 2.5 year follow-up.

Piller NB, Thelander A.

Department of Public Health, School of Medicine, Flinders Medical Centre, Bedford Park, South Australia. binbp@flinders.edu.au

Ten women with unilateral arm lymphedema after axillary clearance (radical mastectomy) and radiotherapy for breast cancer received 16 treatment sessions with Low Level Laser Therapy (LLLT) over 10 weeks and seven patients were followed for 36 months. The effect of LLLT was monitored by arm circumference, plethysmography, tonometry, bioimpedance and a questionnaire dealing with subjective symptoms. After treatment, edema volume (both extracellular and intracellular) was decreased, the tissue (except for the upper arm) progressively softened or approached a normal texture, and the patients reported improvement in aches/pains, tightness, heaviness, cramps, pins/needles, and mobility of the arm. Skin integrity was also improved and the index for risk of infection decreased. Follow-up assessment at 1, 3, 6, and 30-36 months showed varying trends although at 30-36 months most subjective parameters and bioimpedance derived data on ECF and ICF tended to return toward pre-treatment levels. Arm circumference continued to show overall improvement, however, with a volume reduction of the affected arm reaching 29%. Tonometry also showed maintenance of near normal values for the involved forearm and anterior and posterior chest; however, the upper arm showed progressive induration. The data suggest that laser treatment, at least initially, improved most objective and subjective parameters of arm lymphedema

The laser is available for purchase directly through the internet by individuals to use in their home: please note the precautions (at the end in small print) on their brochure.

Precautions

As with any clinical modality for treatment of lymphedema, treatment only should commence after consultation with the patient's oncologist or appropriate medical specialist.  

The clinical trial used to support marketing did not evaluate the safety or effectiveness of the device beyond two treatment blocks (i.e., two cycles of treatment administered every 2 days (three times a week) for three weeks.  Increasing the amount of treatment time or frequency of treatment will not necessarily improve the results.

We would like to see a large study of many women, followed for years after its use, with clinical guidelines.

Now that the laser is used in many clinics, we would like to see data on the clinical experience that has resulted from its use.

Here is a link to what the National Cancer Institute has to say about low level laser therapy:

Low-level laser therapy

Studies suggest that low-level laser therapy may be effective in reducing lymphedema in a clinically meaningful way for some women.[17] Two cycles of laser treatment were found to be effective in reducing the volume of the affected arm, extracellular fluid, and tissue hardness in approximately one-third of patients with postmastectomy lymphedema at 3 months post-treatment.[17] Suggested rationales for laser therapy include a potential decrease in fibrosis, stimulation of macrophages and the immune system, and a possible role in encouraging lymphangiogenesis.[17]

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The National Lymphedema Network, in their recent October-December 2009 Newsletter, Lymphlink Vol.21, No.4, published two very informative articles on use of the low level laser in the treatment of lymphedema.  They have graciously given us permission to attach these articles to our website, and we suggest you read both of them carefully to obtain more information and opinions on the use of the low level laser in the treatment of lymphedema before beginning low level laser treatment.

As Assessment of the Role of Low-Level Laser Therapy In the Treatment of Lymphedema, by Jeffrey R. Basford, MD, PhD and Andrea L. Chevelle, MD, MS.

Question Corner with Kathleen Francis, MD. regarding use of the Low Level Laser Treatment in Lymphedema.

We quote from the last two paragraphs of Dr. Francis' article:

One last consideration: The LLLT devices currently being used to treat LE were "cleared" by the FDA by a process called 510(K), which is not the same as "FDA approved." The 510(K) process is much less rigorous than the FDA approval process for drugs, and does not require any proof of safety or effectiveness.

In summary, LLLT has shown some promise in relieving some of the distressing symptoms of LE, but the evidence for its effectiveness remains limited. Hopefully future studies and wider experience with LLLT will confirm its usefulness as an adjunct to our current approaches in treating LE. In the meantime, it does not appear to be harmful, so you can make your own decision to try it or not based on the available information and your own comfort level with new treatments. Remember to check with your insurance company regarding reimbursement, since many of them do not cover LLLT for use in treating LE.
 

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We again repeat our "Buyer Beware" and suggest that ANY treatment modality you choose to treat your lymphedema should be thoroughly discussed with your lymphedema therapist and your oncologist, and only be used under their guidance and supervision.
 

Page Last Modified 02/16/2014

All medical information presented on this page is the opinion of our Editorial Board and Experts.  See our "About us"  and "Resources" pages.