Lending a Hand: A Very Different Approach To Fibromyalgia

[Cort]

I have purchased the Avacen 100 and would be interested in communicating with the other person who has one to compare experiences.

Good luck Rosebookay - (Like the tag!). Just click on their name next to their post and you can send them a private message. I hope you'll let us know as well how it goes. Again - good luck with it!

 

[Steve]

Hi Rosebookay,
I have used the Avocen for exactly one month, four twenty minute sessions per day, alternate hands, for fibromyalgia and, because I was diagnosed during my trial, "shoulder impingement", very painful but have no idea what it is or what caused it. I have gotten zero pain relief for either condition. I will keep it one more month for my two month trial and unless I get pain relief, back it goes. Will report back then. Be interested in your experience. For the record, my pcp told me yesterday I'm the worst fibro case he's seen, a dubious honor. No meds have helped thus far.

 

[Steve]

Ok, I called Avacen to say I haven't gotten any relief with their device after almost two months and to check on how to send it back. The customer service woman was distressed and offered to have Tom, the CEO who appeared on this thread, call me. He did, from his car, several minutes later, and described his optimism for the device. As they are still getting clearing from the FDA, I won't say more other than to say that he suggested I try it for another month in a slightly different manner and extended my trial. I sure didn't turn that down and will report after that. I think they sincerely want to help patients.

OTOH, my pain management doc, who is also an FM specialist suddenly fired me this morning after I failed Lyrica, saying "try not to focus on the pain and just live your life". WTF. She tossed my medical file on the desk and just walked out. Not a good feeling at all. I'm writing her a nasty letter and trying to cc it to hospital management but they are all MBA's or marketers! Now we know why medicine is &$@&! No chief medical officers!?

 

[Steve]

Hi SML,
To answer your question...pain doc indeed said they won't prescribe opiates unless you have failed Lyrica, Well, I failed Lyrica, then she fired me. The most callous doctor I ever met, whether she prescribed opiates or not. Will let thread know what happens when she gets my nasty letter to her and CMO.
I actually wanted to note that, after exactly 60 days of Avacen heat treatment, I have returned the device today. I would have taken them up on their nice offer for another trial month but I have to leave town for several weeks and did not want to be shipping this across the country. If I had gotten a smidgen of relief I would have continued somehow but nada. Tom, the CEO, was quite optimistic about it eventually working for me as they apparently have a very good track record. My track record is of failing Neurontin, Cymbalta, Lyrica, Elavil, LDN, Tramadol, Quell TENS, innumerable supplements, yoga, and a bunch of other stuff I have forgotten, even a sleep inducing hat. I am messing around with medical MJ edibles, very difficult IMO, and I would say many days I am in desperate pain, probably like many here. I guess I will start retrying the least crummy meds, maybe Cymbalta, but I am hoping some time to retry LDN, though my guess is that I'm just a nonresponder to it. I'll start the search for a new pain doc, very difficult in my semi-rural location. I had hope for the Avacen and it's probably worth the $300. trial if you can put out the full amount until you know if it works. Of course,if it worked for you, you'd say "paper or plastic" forever to pay for it. GLTA.

 

[Thomas Muehlbauer]

I’m always interested in esoteric medical devices, but this throws up a few red flags for me. I’d be interested if Tom or anyone else from Avacen could comment.

• The supposed benefits come from “relaxation” of your body & muscles, and that increased blood flow will provide more nutrients to your body/muscles, reducing pain symptoms.
• I image this benefit is simply from vasodilation due to the warmer blood being circulated in the body. While the hand warming device is novel, I’m not sure why other forms of warming wouldn’t achieve the same effect. For example, you can buy cheap/goofy FIR sauna tents on eBay which will heat your body up, making you “relax”, and presumably giving you the same benefits (if they exist) that this does.
• I’m curious about how worthwhile this approach is for people with dysfunctional circulatory systems (POTS, autoimmune, etc). For e.g. I have a lot of problems with thermoregulation (can’t cool down when hot, can’t heat up when cold), and I’m not sure a device relying on a functional circulatory system to do it’s job (i.e. pump blood in response to temperature changes) is a great idea for ME/CFS.
• I’m not sure why the vacuum is particularly necessary, though I’d be interested in Tom’s thoughts here. A similar product exists called Avacore (http://www.avacore.com) that uses cooling, not heating, to (supposedly) increase athletic performance. The vacuum + cooling makes sense there because they’re trying to defeat vasoconstriction, and cool muscles down so (theoretically) those muscles recover faster to do more reps. I’d be interested to hear why a vacuum + heating is necessary, given the point of Avacen is to promote, not workaround, vasodilation.
• (As a tangent, people have been making DIY vacuum cooling gloves too: http://instructables.com/id/CoreControl-DIY/ .)
• Finally, for people following along, be wary of the anecdotes — you may be able to achieve (or at least test) the same effect far more cheaply, and people will write glowing testimonies for all kind of dubious “pain” treatments (see: every “magnetic” health product sold).
• Their study is junk without controls. This is the sort of study you do for marketing cred, not scientific cred. Caveat emptor!

Dear Luke,
I’m embarrassed by the untimely response to your post. I first saw your post a couple of weeks ago when our digital marketing person came across it. Due to the extensive nature of your post I set it aside to a time when I could devote the time such a post deserves. You bring up some great questions and I appreciate you giving us a chance to respond.

First off, not all warming devices are the same and there are no similar devices. Our FDA-cleared and patented device and process (3 U.S. and 8 International patents) uses negative pressure to expand and keep the Arteriovenous Anastomosis vascular bed in the palm of the hand (our portal into the circulatory system) vasodilated so as we simultaneously apply heat to this pool of blood, this allows us to continue to slowly and safely raise core body temperature to the point where the peripheral capillaries dilate to radiate this excess heat. The net effect of this complex process is to warm the body from the inside out therefore increasing muscular relaxation throughout the body. The application of negative pressure and heat is clinically proven to be more effective than heat alone (Grahn et al 1998). Link:
http://journals.lww.com/anesthesia-...volution_of_A_Technique_for_Treating.204.aspx

Our device has over 3,000 firmware instructions to manage this process safely. Those “goofy” devices you recommend, can seriously damage the skin because they apply heat externally (LOL, I thought I was the only one who used “goofy” when describing such treatment modalities). Because they can only treat a localized area, after a few minutes their external application of heat causes the underlying capillaries to vasoconstrict in order to maintain core body temperature at normothermia. From that point forward the “goofy” devices simply cook the skin. The AVACEN 100 utilizes a much more subtle heat technology platform that allows the body to naturally and safely handle this heat infusion, which prevents the body from dangerously overheating, which could happen with saunas.

Concerning your question regarding a dysfunctional circulatory system; it is estimated that 80% of the population over 40 have compromised microcirculation. We believe our wide range of effectiveness for many different maladies points to our effect on increasing whole body microcirculation. In addition, a more gradual heat infusion platform is a much safer option for any systemic dysfunction.

As for throwing our study into the “junk” category; I am not sure why you said that but I respect your skepticism. It is not easy to have a control group when subjects can sense if the heat is being applied. In a perfect world, a double-blind placebo-controlled randomized study would have been ideal (wish we had the deep pockets of big pharma…).

Given the fact that heat or no heat is almost impossible to blind, we compared Group A’s 10-minute once a day sub-therapeutic dose against Group B’s therapeutic dose of 15-minutes twice a day. The results were extremely convincing.

Yes, our study had a low number of subjects but we had exceptional results. Even the FDA accepts that a high result with a low number of subjects can be equivalent to a large number of subjects with minimal results. Just take a look at the FDA approved drugs for fibromyalgia. They all had minimal clinical results but they were from a large population.

I am very proud of our study and results: https://clinicaltrials.gov/ct2/show/NCT01619579?term=avacen&rank=1

Currently there is a manuscript being completed which should be peer reviewed and published with the next 12 months.

When judging the quality of our trial I think it would be fair to:

1. Examine the University of California San Diego and Department of Veteran Affairs IRB approved 15 page research plan which has numerous scientifically recognized controls.
2. Review the credentials of the 5 amazing MD’s and researchers who conducted the study.
3. Evaluate the 10 endpoints that were studied and reported on.
4. Understand that the trial consisted of 56 separate treatments over 28 days for each subject.
5. Take a look at the Board of Directors (https://avacen.com/team/board-members/) of the company (AVACEN) who sponsored the trial which includes the innovator of Savella.

Just so you know… you’re not in a unique club with your opinions. Such opinions are not unusual when a new, innovative and disruptive medical device is presented to the scientific community. Most Western doctors need a “stamp of approval” such as a peer reviewed and published study before they begin to use a product such as ours.

I personally believe it is just as important to understand the validity of the mechanism of action and then ask yourself… does that make sense?

Our priority as a company has always been to demonstrate efficacy and safety while simultaneously exploring the mechanism of action of our technology. Many of our physicians and patients feel our clinical data is sufficient to at the very least try our non-invasive technology which has been cleared as safe by the FDA for over-the-counter (OTC) sales. Others want to better understand why and how our device is effective. As I mentioned above, there also is a portion of the community that will not believe anything until it is published in a peer-reviewed journal. I find this interesting because people have been taking aspirin, ibuprofen, and other OTC medications for decades without reading their clinical studies or safety profile.

As a small company with a disruptive medical device, I am extremely proud of the progress we have made thus far, but we realize our clinical credibility can always be improved. But, there comes a time when development cost and product launch date has to supersede the demands of those who desire years of million dollar studies comprised of hundreds of subjects in multiple geographic areas. The costs associated with the foregoing data collection and analysis must be minimized if an affordable effective consumer product under $3,000 is the desired result. This is especially true with a noninvasive and safe device (ZERO negative reports for 100% of over the 500,000 treatments).

Your comment that our study was done for marketing purposes is 100% correct. I really can’t think of one medical device (or drug) study that was done for any other purpose. Even the National Institutes of Health require, in their research grant application, that you prove there is a path to commercialization.

And finally (I know you thought my response would never end) you’re Caveat Emptor recommendation is not necessary when buying our product. We have come to understand that everyone’s medical history and condition is different… therefore, we don’t wish to inflict any additional stress into our customer’s life by having them pay for something that doesn’t work. Thus, we have recently changed our trial policy. If used as recommended, and if it doesn’t help, we guarantee a 100% return of all monies paid to purchase our device - including shipping costs both ways! Details: www.avacen.com

Thanks again for you interest and wishing you good health, TOM

 

[Cort]

Dear Luke,
I’m embarrassed by the untimely response to your post. I first saw your post a couple of weeks ago when our digital marketing person came across it. Due to the extensive nature of your post I set it aside to a time when I could devote the time such a post deserves. You bring up some great questions and I appreciate you giving us a chance to respond.

First off, not all warming devices are the same and there are no similar devices. Our FDA-cleared and patented device and process (3 U.S. and 8 International patents) uses negative pressure to expand and keep the Arteriovenous Anastomosis vascular bed in the palm of the hand (our portal into the circulatory system) vasodilated so as we simultaneously apply heat to this pool of blood, this allows us to continue to slowly and safely raise core body temperature to the point where the peripheral capillaries dilate to radiate this excess heat. The net effect of this complex process is to warm the body from the inside out therefore increasing muscular relaxation throughout the body. The application of negative pressure and heat is clinically proven to be more effective than heat alone (Grahn et al 1998). Link:
http://journals.lww.com/anesthesia-...volution_of_A_Technique_for_Treating.204.aspx

Our device has over 3,000 firmware instructions to manage this process safely. Those “goofy” devices you recommend, can seriously damage the skin because they apply heat externally (LOL, I thought I was the only one who used “goofy” when describing such treatment modalities). Because they can only treat a localized area, after a few minutes their external application of heat causes the underlying capillaries to vasoconstrict in order to maintain core body temperature at normothermia. From that point forward the “goofy” devices simply cook the skin. The AVACEN 100 utilizes a much more subtle heat technology platform that allows the body to naturally and safely handle this heat infusion, which prevents the body from dangerously overheating, which could happen with saunas.

Concerning your question regarding a dysfunctional circulatory system; it is estimated that 80% of the population over 40 have compromised microcirculation. We believe our wide range of effectiveness for many different maladies points to our effect on increasing whole body microcirculation. In addition, a more gradual heat infusion platform is a much safer option for any systemic dysfunction.

As for throwing our study into the “junk” category; I am not sure why you said that but I respect your skepticism. It is not easy to have a control group when subjects can sense if the heat is being applied. In a perfect world, a double-blind placebo-controlled randomized study would have been ideal (wish we had the deep pockets of big pharma…).

Given the fact that heat or no heat is almost impossible to blind, we compared Group A’s 10-minute once a day sub-therapeutic dose against Group B’s therapeutic dose of 15-minutes twice a day. The results were extremely convincing.

Yes, our study had a low number of subjects but we had exceptional results. Even the FDA accepts that a high result with a low number of subjects can be equivalent to a large number of subjects with minimal results. Just take a look at the FDA approved drugs for fibromyalgia. They all had minimal clinical results but they were from a large population.

I am very proud of our study and results: https://clinicaltrials.gov/ct2/show/NCT01619579?term=avacen&rank=1

Currently there is a manuscript being completed which should be peer reviewed and published with the next 12 months.

When judging the quality of our trial I think it would be fair to:

1. Examine the University of California San Diego and Department of Veteran Affairs IRB approved 15 page research plan which has numerous scientifically recognized controls.
2. Review the credentials of the 5 amazing MD’s and researchers who conducted the study.
3. Evaluate the 10 endpoints that were studied and reported on.
4. Understand that the trial consisted of 56 separate treatments over 28 days for each subject.
5. Take a look at the Board of Directors (https://avacen.com/team/board-members/) of the company (AVACEN) who sponsored the trial which includes the innovator of Savella.

Just so you know… you’re not in a unique club with your opinions. Such opinions are not unusual when a new, innovative and disruptive medical device is presented to the scientific community. Most Western doctors need a “stamp of approval” such as a peer reviewed and published study before they begin to use a product such as ours.

I personally believe it is just as important to understand the validity of the mechanism of action and then ask yourself… does that make sense?

Our priority as a company has always been to demonstrate efficacy and safety while simultaneously exploring the mechanism of action of our technology. Many of our physicians and patients feel our clinical data is sufficient to at the very least try our non-invasive technology which has been cleared as safe by the FDA for over-the-counter (OTC) sales. Others want to better understand why and how our device is effective. As I mentioned above, there also is a portion of the community that will not believe anything until it is published in a peer-reviewed journal. I find this interesting because people have been taking aspirin, ibuprofen, and other OTC medications for decades without reading their clinical studies or safety profile.

As a small company with a disruptive medical device, I am extremely proud of the progress we have made thus far, but we realize our clinical credibility can always be improved. But, there comes a time when development cost and product launch date has to supersede the demands of those who desire years of million dollar studies comprised of hundreds of subjects in multiple geographic areas. The costs associated with the foregoing data collection and analysis must be minimized if an affordable effective consumer product under $3,000 is the desired result. This is especially true with a noninvasive and safe device (ZERO negative reports for 100% of over the 500,000 treatments).

Your comment that our study was done for marketing purposes is 100% correct. I really can’t think of one medical device (or drug) study that was done for any other purpose. Even the National Institutes of Health require, in their research grant application, that you prove there is a path to commercialization.

And finally (I know you thought my response would never end) you’re Caveat Emptor recommendation is not necessary when buying our product. We have come to understand that everyone’s medical history and condition is different… therefore, we don’t wish to inflict any additional stress into our customer’s life by having them pay for something that doesn’t work. Thus, we have recently changed our trial policy. If used as recommended, and if it doesn’t help, we guarantee a 100% return of all monies paid to purchase our device - including shipping costs both ways! Details: www.avacen.com

Thanks again for you interest and wishing you good health, TOM

Thanks for that very complete answer. Good luck with the paper