The Flexitouch Device - Initial Observations

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The Flexitouch Device - Initial Observations

Postby patoco » Sun Jun 11, 2006 9:26 am

THE FLEXITOUCH DEVICE – INITIAL OBSERVATIONS

Pat O’Connor

Lymphedema People

http://www.lymphedemapeople.com

October 17, 2005

Preface:

The information contained herein is not meant to be an endorsement of the Flexitouch Device and in designed to be an educational advisory to lymphedema patients. Also, I have received no compensation for this article and in fact, I was not asked by Tactile Systems to write this.

My opposition to use the use compression pumps for the treatment of lower limb lymphedema is well known. Due to the well documented incredibly high risk of genital lymphedema, I personally just don’t feel they should be used.

Upon my review of the Flexitouch device, it seemed to be such a radical departure from the products we are familiar with, that I felt further investigation was warranted.

I also want it noted that I went into this demonstration with a cynical attitude and looking for any reason to not like the device.

Our Problem:

The biggest challenge those of us with lower limb lymphedema is perhaps how to maintain the reduction of swelling achieved after decongestive therapy treatments. We all know the importance of patient compliance in the maintenance phase of lymphedema management. However, with leg lymphedema that is easier said then done.

First, self massage therapy (simple decongestive therapy) is all but impossible without the assistance of another individual. Secondly, the compression hosiery has been for me a nightmare. I stopped using them decades ago because of complications involved. A couple years ago I tried again, hoping there had been an improvement in the product design. What I found was the same complications. Severe bunching and cutting off of circulation at the groin, knee and ankle caused me to once again discard the idea.

My Concerns:

My concerns about the product were three fold. First, basically does the device work towards the reduction of swelling. Secondly, with the pressure used, what is the risk of damaging the delicate superficial lymphatics. Third, what would be the possible risk of genital lymphedema as a result of using the device.

After treatment I was very careful to pay extremely close attention to any scrotal edema and to watch for any residual discomfort in any treated area. This included watching for discomfort in any nodal regions that had been treated.

On that I am able to report there was absolutely no change in scrotal size and not even a hint of residual pain of any type.

The Company:

I will say that I was favorably impressed and pleased that the representative from Tactile was also a registered nurse instead of simply a salesperson hawking a product. The rep also answered each and every question I had in a thorough and knowledgeable manner.

In review the company staff, I was also impressed with the number of medically trained people in the company.

They also have a complete appeals section staff that will do all the work necessary should your insurance company deny coverage.

Also, I want to emphasize, the company is marketing this and makes a very clear point of saying the device is not in any way meant to replace the all important decongestive therapy that we all should have. Instead, they stress that this is an adjunctive tool to be used at home in a maintenance program after you go through your prescribe treatment protocol with a therapist.

The Garment:

The garment used was a soft fabric and is wrapped around the leg and abdomen. It is held in place by Velcro, which means it can be adjusted specific to the individual needs of the patient. For the purpose of the test, I chose the firmest fit.

It is also composed of 32 separate chambers and provides a very gentle ripple effect versus the “squeeze” effect used by pumps.

Preparation Phase:

One of the claims of the company is that the device follows the same preparation protocol used by lymphedema therapists. I found this to be accurate. You go through an initial thirty minute preparation phase where at first the abdominal lymphatics are cleared and then subsequent preparation of the leg. The pressure used was extremely light and did in fact follow exactly the lymph flow patterns that a therapist would use.

Treatment Phase:

Once the prep stage was completed, a thirty minute treatment phase began. The experience was one of a gentle ripple effect that went from toes to abdomen. The pressure again was gentle and light.

The Experience:

I must say that overall the experience was extremely comfortable and even relaxing as it felt much like a massage. There was absolutely no pain or discomfort and not once did the thought come to mind that “I can’t wait for this to be over.”

The result:

Before we began treatment, the leg was marked and measured. Afterwards, using the same mark, there was a 2 centimeter decrease in limb size.

Contraindications for Usage:

There are of course, contraindications for the usage of the device as would be common with pumps or actual hands on therapy by a therapist.
I would add two more relevant ones.

First, I am still too uncomfortable with possible complications to suggest anyone try any device and/or pump is you already experience any type of genital lymphedema. This would be true for male and/or female.

Secondly, and this is strictly individual, is that if you have any extent of pleural effusions (lung fluid), you should not use it.

As the device cleared the abdomen, the fluid was moved upward. In my personal situation with lymphoma being spread throughout the lymph system and with the extensive pleural effusions I have, I experienced a serious problem with breathing.

This did clear up after I had been up again, and I have no residual problems today.

Drawbacks:

The central drawback may be in the price.

Conclusions:

First, I want to say that I am very pleased that the pressure on the machine is preset at the factory and can not be changed. This eliminates the risk that we have sometimes thinking if some pressure if good, more pressure is more effective. That means the device is safe from patients causing self injury by the miss use of the strength of the pressure.

Also, due to the light pressure used and the very gentle rippling effect of the therapy, in my personal opinion, I don’t see how this device could possible cause damage to the superficial lymphatics.

Second, what is still needed is a study on the possible risk of genital lymphedema. Without such a study it is not possible to say emphatically that the device will not cause that complication. However, having said that I would be extremely surprised if the device did cause it. This is a result of the preparation phase, clearing of the abdominal lymphatics and the gentleness of the ripple pressure used.

Finally, for many years I have wondered why a pneumatic device could not be invented that was safe, effective and that mimicked hands on decongestive therapy. Clearly, the Flexitouch is the closest device to that I have seen and I must candidly admit, I am excited about the potential here.

I am not a medical professional, nor have had formal medical training. The opinions expressed herein are my own personal opinion based up a personal review, test treatment session, my experience with lymphedema and knowledge of the lymphatic system.

© 2005 Pat O’Connor, Lymphedema People. Written authorization must be obtained before the reprint, reuse or republishing of this article or any part therein.
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Machine for Manual Lymph Drainage

Postby ppaesch » Wed Aug 23, 2006 10:45 am

Thank you, Pat, for your very comprehensive article on the Flexi-Touch
machine. Yes, this is the machine I tried. I do have genital lymphedema
and your comments are certainly food for thought. Thank you very much.
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Postby suzz7432 » Fri Sep 22, 2006 3:57 pm

Pat,
Thank you for sharing. Your observations were thorough and informative. I will discuss this with my therapist to get his feedback.

Take care,
Suzz
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Postby Kim » Thu Aug 09, 2007 10:14 pm

I tried the Flexi-Touch machine today. There was a representative at my therapist's office today, and my therapist needed someone to try it out to see the results first hand. My therapist knows my body well, knew that it would be safe to use. and assured me to stop the treatment if at anytime I was concerned about anything.

I enjoyed the treatment; it was very relaxing. After the treatment, I had my regular therapy session with my therapist so that she could see and feel the results right away. The superficial flow was fantastic, but the treatment didn't touch the deep stuff, which I have more trouble with than superficial.

I can see this system being really great for someone who is unable to do MLD on themselves. Sure, I would love to have it so that I could just sit back and relax, instead of doing the daily MLD on myself. With no insurance though, there is no way that I could ever afford to purchase it. For those who have insurance or the dollars, it could be well worth looking into.

Kim :)
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Postby Kim » Fri Aug 24, 2007 11:02 am

Within three days of using the Flexitouch system, I started having genital swelling. :x I am truly miserable and not happy about this at all. The burning and swelling is just awful.

What really makes me angry is that i was doing so much better, and I only have myself to blame for this new development.

So advice to others...better think twice or more before using this system.

Kim
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Postby patoco » Mon Aug 27, 2007 8:44 pm

Hey Kim

Your must let the company - http://www.tactilesystems.com/ know about this. I am so sorry to hear that you ahd this happen, but we need to know and the company needs to give a response.

My best to you

Pat
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Postby Kim » Mon Aug 27, 2007 11:18 pm

Hi Pat,

My therapist is going to call the representative and let her know.

This is one of those times where I wish I could have "redo"!

The swelling is a bit better, thankfully!

Kim
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Flexitouch

Postby Tania » Thu Aug 30, 2007 11:47 pm

I tried out this system for a couple of weeks at home. It was comfortable and easy to use, but it didn't reduce my measurements. :(

I returned it with no problem.
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Postby raingoddess 2 » Thu Oct 18, 2007 8:38 pm

hi everybody, it has been a long time since I have been on the boards, but this topic caught my eye. I have tried the Flexitouch device and both my thearpist and I were impressed enough to see if it was covered. My age had a lot to do with this descision, since I am 18, and the fact that my LE has never brought on infections or complications of any sort. This also brought forth :lol: the insurance covering it! A 10,000 dollar machine that I hope will do what it is intended, I will be recieving it shortly, so let's see what happens!
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Re: The Flexitouch Device - Initial Observations

Postby armywife » Thu Feb 26, 2009 1:32 pm

Hi Pat,
Was going to ask the group if anyone had used this type of pump and found your well written experience. I just had the chance to use one yesterday while I am in MLD therapy.
I did have the sales rep with no medical backround. But he was very knowledgable and able to answer all my questions and gave me clinical trial studies to show my doctor. My PT has had pts use it with great results.
I had your same experience. Very easy to put on..relaxing for an hour( which I can do now that the kids are out of the house) and no ill effects when we were done. I am having them go ahead and process the order and get my insurance involved...pump costs about 9K....my insurance will pay x amount...and I pay 20% of that. Rep told me they do have hardship clasues people can apply for( not in my case) but also due to economics as it is...billing is more than willilng to help with payment options for up to 2 years with no intrest...so they are willing to work with the patient.

My other concern...there are no long term studies done on potential harmful side affects...its just been approved by fda in 2003.....woulod that stop me from buying it? I don;t think so.

If anyone already has one and wants to share their experienc with it...I would love to hear about it.....

Also..am going to try and get Farrow Wraps instead of the compression bandages next....and last but not least....has anyone been put on Coumarin(not COUMADIN blood thinner) to helpo with lymphedema? Clical trials?? I would like to try this and be monitored by a doctor....next discussion with doctor for me!

Take care,
Armywife
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Re: The Flexitouch Device - Initial Observations

Postby Liatris » Tue Aug 11, 2009 11:29 pm

Hello ARMYWIFE !!

I have been doing a lot of research on coumarin (not coumadin) and know of someone who says she is getting good results with it used topically.

Since I do not know if you will be coming back here, I will wait to hear from you before I get into any specifics. I would love to share what I have learned.

Liatris
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Re: The Flexitouch Device - Initial Observations

Postby patoco » Wed Aug 12, 2009 10:03 am

Hi Liatris

One must use extreme caution when thinking of using coumarin. While it has shown some effect in helping edema, there is still the problem of hepatotoxicity which they have not solved.

Even topical courmarin can be dangerous. It has strong anticoagulant properties that could serious for many with lymphatic and or venous conditions.

Please, please before you do anything like this, you absolutely must do so only on the consultation of your doctor. You must undertand how any medicine/substance is going to react with any co-morbidities you might have.

Pat
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Re: The Flexitouch Device - Initial Observations

Postby Liatris » Wed Aug 12, 2009 8:24 pm

patoco wrote:Hi Liatris

One must use extreme caution when thinking of using coumarin. While it has shown some effect in helping edema, there is still the problem of hepatotoxicity which they have not solved.

Even topical courmarin can be dangerous. It has strong anticoagulant properties that could serious for many with lymphatic and or venous conditions.

Please, please before you do anything like this, you absolutely must do so only on the consultation of your doctor. You must undertand how any medicine/substance is going to react with any co-morbidities you might have.

Pat



Hello, Pat -

Thank you for your concern. In my investigative digging for information on coumarin, I spoke with the researchers who were looking into the efficacy and safety issues. The studies that the Casley-Smiths carrried out revealed a high success rate and much lower incidence of hepatotoxicity than the Mayo Clinic study - this is, in deed, something to wonder about, ponder and this makes one think that further investigation is called for- to determine why the gap is so large. I agree that those who take it should have their doctors monitor their liver.

Having said that, I have to correct a common misconception about coumarin - it has NO anticoagulant properties. The internet is littered with this confusion which keeps this misconception alive. CoumaDin is a strong anticoagulant and is a coumarin derivative - but it is not coumarin. This misconception is so prevalent that people who have been prescribed courmarin by their doctors have had coumaDin dispensed and have been disappointed not only because of the coumaDin's side effects of bruising and such but, of course, they received no anti-edema benefits. Even requesting the coumarin with the correct CAS # does not guarantee that you will get the coumarin instead of coumaDin ! I even spoke with a pharmacist who has dipsensed it for years and told me to be careful because "it is rat poison" - she was, of course referring to coumaDin - not coumarin. There are those who are receiving benefit when they apparently are being given the real coumarin.
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Re: The Flexitouch Device - Initial Observations

Postby patoco » Thu Aug 13, 2009 8:52 am

Hi Liatris

Ironically, while you are stating that the Casley-Smith study was more accurate; coumarin which was once legal in many countries has been pulled of the "allowed" list because of the hepatotoxicity of the drug. I'm not sure what you are sayng about the internet as I do not use the regular internet for my research. I use only accredited evicence based science/medical sites for my information. It is replete with reports and documentation of liver damage caused by coumarin. What was actually found was the opposite. There is some question about the initial Casley-Smith studies because of the experience of patients around the world and the methods used.

Thank you for explaining the difference between coumarin and "coumaDin." It is really quite possible that I do understand the difference. The are strong warnings about using COUMARIN if you have a history of bleeding problems, (Inform your doctor if you experience: unusual bleeding or bruising, blood in the urine or stools).

You are warned to inform your doctor if: Before taking this drug, tell your doctor your medical history, especially of: bleeding problems ,. Indeed, in a medical setting coumarin glycosides HAVE
been shown to have blood-thinning properties. Dicumarol, a coumarin glycoside better known as warfarin, is the most commonly used oral anticoagulant medication.

http://www.phytochemicals.info/phytoche ... umarin.php

http://www.medicinenet.com/coumarin-typ ... rticle.htm

http://micro.magnet.fsu.edu/phytochemic ... marin.html

So, I will stand by my comments and my warnings.

Pat
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Re: The Flexitouch Device - Initial Observations

Postby omi » Fri Oct 02, 2009 11:21 am

Not sure I am in the right forum or even doing this post correctly. I have been given the chance to purchase(through insurance)the Flexitouch (lower extremity), I see posts from two years ago, but not more recent ones, anybody out there been on this machine on a regular basis? My lymphedema is contained to an upper thigh and left pelvic side, so I do have some concerns of what I have heard could be possible side effects by using a pump. I understand that the flexitouch is different from the traditional leg pumps but still would like to hear people's(besides the people interviewed on Flexitouch's webpage) experiences.
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Re: The Flexitouch Device - Initial Observations

Postby jervin » Fri Oct 23, 2009 10:51 am

1) I would suggest that those of you considering the use of the Flexitouch System take a look at the documented research and resources available on the Tactile Systems Technology Inc website (http://tactilesystems.com/). Though one can assume, from a marketing perspective, that it favors the system, it nevertheless documents a strong research and development effort ongoing to further improve this product.

2) I posted the following on another list serve, but think it worthwhile to add here as well .....

- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

To Pat's note on the potential use of coumarin-type drugs for LE, I might add the following:

I have taken Warfarin (a coumarin/coumadin drug) on a regular basis for several years as treatment for a chronic atrial fibrillation (irregular heartbeat) condition and can tell you that it has a very strict protocol for its use.

Since it is a powerful, blood-thinning medication used primarily to disperse blot clots, it should only be used under supervision of a coagulation specialist and monitored on a regular basis through the use of prothrombin time (PT) and its derived measures of prothrombin ratio (PR) and international normalized ratio (INR) tests, determined through recurring blood draws in a clinical lab environment.

These tests are measures of the extrinsic pathway of coagulation. They are used to determine the clotting tendency of blood, in the measure of warfarin dosage, liver damage, and vitamin K status. I won't go into the reference ranges for prothrombin time or the normal range for the INR because ranges may vary depending upon one's associated medical conditions.

NOTE: Pharmacologic therapy as a means of treatment uses antibiotics to treat and prevent bacterial cellulitis and lymphangitis. It should be noted that other drugs that have been used include diuretics, anticoagulants, pantothenic acid, pyridoxine, and hyaluronidase. However, these drugs have no proven therapeutic value and may cause adverse reactions

Jerry E.
Edina, MN
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Re: The Flexitouch Device - Initial Observations

Postby patoco » Sun Oct 25, 2009 10:37 am

Hey Jerry and Omi

Just got back from the Lighthouse Georgia Lymphedema Awareness program...so the ole man is really worn.

I wanted to add that I had a great chance again to chit chat with Flexi at the program and they are working on more products and having more studies conducting. So, I am and remain pleased. They do seem to be sensitive to what exactly our needs are in both managing our LE and in helping us to regain more control over our lives and abilities.

As soon as I get rested, I'll make it back and report more.

Pat
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