Lending a Hand: A Very Different Approach To Fibromyalgia

Discussion in 'Relieving Pain' started by Cort, Dec 24, 2015.

  1. Cort

    Cort Founder of Health Rising and Phoenix Rising Staff Member

    And now for something completely different. Forget the drugs - how about putting your hand in something and watching the pain ebb away... Science fiction? One company thinks not.

    Avacen100.jpg
    The AVACEN corporation touts their AVACEN 100 as the only medical device that's able to provide noninvasive, rapid whole-body muscular relaxation. They assert that simply applying the AVACEN 100 to the blood vessels of the hand will increase the blood flows throughout your body, releasing muscle tension, increasing your core body temperature and reducing sympathetic nervous system activation.

    Stopped Up Reservoirs?

    The hands, it turns out, contain far more blood than they need to operate. They provide a reservoir for blood that's used to quickly shunt blood to areas of the body that need it. Studies, show, for instance, that blood flows out of our hands and into our muscles when we exercise. When we start to overheat more blood flows into our hands to dissipate heat to the outside.

    Heart_blood_vessels.jpg

    In 2013, Health Rising covered a study suggesting, though, that the shunts that transfer blood out of the hands of fibromyalgia patients aren't working properly. Rice's 2013 study indicated that FM patients may have trouble releasing the blood locked up in their hands.
    AVACEN believes its product can painlessly increase blood flows and relax the muscles in about 20 minutes. Simply stick your hand in the machine, they say, and watch your muscles relax, your pain and stress decrease, and your thinking become clearer.

    Could it be so easy? The machine works by affecting blood vessels in the palms of the hands called the arteriovenous anastomosis (AVA's). It produces 3,000 microprocessors to produce negative pressure and heat in order to push heat back into the body. (The negative pressure is key; putting your hand in warm water will not work.) That heat reduces the blood’s thickness and increases blood vessel dilation allowing it to flow into the microvascular circulation in the body.

    The increased microvascular circulation should increase oxygen delivery and nutrition to the muscles while carrying away toxins at the same time. It should also increase core body temperature - a problem for many FM and ME/CFS patients - and reduce sympathetic nervous system functioning.

    On one page of their website they show a picture of capillaries in a finger filling with blood after using the machine. The kicker is that the finger is on the hand that was not put in the machine.

    AVACEN proposes that the AVACEN 100 does for blood and tissue oxygenation what hyperbaric oxygen treatment is purported to do at a much lower cost. Instead of entering an oxygen chamber you simply put your mitt into the AVACEN machine. They also assert that the treatment is side-effect free.

    Successful Clinical Trial

    Avacen-Results-II.jpg
    AVACEN recently announced the results of a Phase II clinical trial. The month-long study, which took place at the University of California at San Diego involved 22 FM patients (and no healthy controls). Most did two 15 minute treatments a day. Those who did reported a 40% reduction in widespread body pain.

    Conclusion

    This intriguing product purports to help with three major problems - muscle tension, reduced blood flows and sympathetic nervous system activation - in fibromyalgia and ME/CFS - and to do so relatively cheaply and without side effects.

    The study was primitive (no placebo controls, few measures of symptom reduction), but it did take place under the aegis of the University of California at San Diego, and the company is going for FDA certification. If it gets it the AVACEN 100 could provide a useful adjunct treatment for FM and ME/CFS. There's little sense that it could cure FM but a 40% reduction in pain is nothing to sneeze at. This little machine looks like it’s something to keep an eye on.

    The AVACEN 100 is FDA cleared and available for sale in the US as a medical device for muscular relaxation and the relief of localized pain such as minor muscle pain, stiffness, joint pain, muscle spasms, etc. (The company is now trying to get it licensed for widespread pain.)

    At about $2,000 it's not cheap, but then again that should be a one-time outlay. It comes with a six-month money-back guarantee (minus 15%). It's not for sale to use for widespread pain or fibromyalgia. It does not require a doctor's prescription.

    One testimonial on the site states

    Check out AVACEN here.

    Health Rising is not affiliated with AVACEN in any way.
     
    Last edited: Dec 25, 2015
    Linda G. likes this.
  2. Phil Hayward

    Phil Hayward Member

    My intuition is that the blood is getting trapped in the hands because of vasoconstriction back up the arms and into the torso area on the way back to the heart. I think that tissue tightness in FM victims, including in the myofascia, is part of a vicious circle where blood vessels are constricted, and probably lymphatic vessels as well. Which comes first - the tightness or the vasoconstriction? Could the vasoconstriction be some kind of protection response in the presence of infection or toxins in the blood? Or some hypothesize an auto-immune problem. I am prepared to believe in the "toxins" theory as hair mineral analysis tests show me long since to have had a cadmium poisoning problem that is slowly going away. The noted naturopath Gary Moller insists that everyone who has come to him with fibromyalgia, has had one or more toxic elements in elevated quantity show up in HMAT; and/or an undiagnosed chronic infection somewhere in the body.

    Maybe one of these Avacen gadgets would speed up my progress; but as you know, Cort, I am very pleased with the gains I have made in the last 2 years with a self-designed protocol (couldn't have done it without the research information on this blog) - that includes a series of stretches done in the hot water of a spa pool. And my whole overall approach including diet, paced exercise, massage and supplementation has somehow mobilised my system to get the cadmium, and lead, and excessive calcium, reducing.

    I just don't know if I could have left out any particular part of my protocol and still got better - I am inclined to think it is necessary to "do everything". The physical stuff possibly helps the body to shift the toxins. My overall sensation is very much that the locations in my body where the problem pains and knots and lumps and tension are, are only slowly having these things "flushed away starting from the outside edge and gradually going deeper or further up or down my limbs".

    Massage therapist is now noting improvement at last in the very deepest problem "spots" in my calves and thighs. It has been a slow process; 2 years ago I could not squat; I still cannot squat for long without pain building up but being able to squat at all is a blessing. My latest milestone is that I can now do "burpees" - something that was beyond my wildest dreams as recently as 2 years ago - and I am 50 years old, and have been debilitated for 20 years. Of course I have to stick to only doing 4 or 5 of them or I am going beyond what is wise for pacing.

    It is the weight bearing exercise, even walking, that remains hardest but I am slowly making gains there. I am flexible enough now to be able to break into a brief sprint, but certainly can't sustain even a gentle jog for more than about 3 minutes without provoking post-exertion malaise. But I think I am gradually extending my limit. Aquaerobics which I have been experimenting with recently, I think are very important - I am giving those "running muscles" a workout and conditioning under low load (i.e. supported by water). Then they gain condition to the point that they are functioning better when I do try and run on terra firma.

    So I reiterate, I think the right physical conditioning is all part of regaining lost mobility and flexibility; and maybe the Avacen gadget would help things along too. I also believe that supplements that enhance vasodilation, and anti-oxidants, are of benefit once the fibro sufferer is making progress like I am - I believe these supplements have trouble "getting through at all" while the system is at its worst-choked-up state. I do wonder if I might note more benefit from MitoQ, for example, than someone stuck in the worst chronic state - in fact just about everything that "might help", probably works better, the better you already are. The sensation I have now, is that I have got over the top of a peak, and full recovery is now a case of flushing away the remaining toxin repositories and continuing to work on mobilising the last, slowest-responding few muscle groups and releasing even the oldest tight knots and lumps. Instead of feeling like my whole body and cardiovascular and musculoskeletal systems are trapped in malaise, I now feel like the overall systems are functioning, and are actively carrying out mopping-up operations in the remaining problem areas.

    Different approaches may work for different people - depending on body type and so on, and the possibly widely-differing underlying causes of fibro in different patients; but I am convinced that multi-faceted, holistic protocols are a must.
     
    Last edited: Dec 24, 2015
    Tami, Tammy7, Cort and 1 other person like this.
  3. VLynx

    VLynx Member

    Thanks for the update, Cort. I was intrigued when you first discussed this research (has it really been over 2 years!).

    I was going to comment on your most recent drug post that I think that the future of pain control is not in drugs at all. I don't think any drug will ever replace opioids for pain control. Rather, I think the future lies in technology. I was thinking more along the lines of neurotechnology: transcranial magnetic or electrical stimulation, or other neuromodulatory modalities. This, though, is another approach. I'd love to try it. I think I'd need to know it would work before laying out $3K, though.
     
  4. Steve

    Steve Active Member

    Interesting, Cort, always gets one's hope up but doing a crummy study with low N and no controls doesn't inspire confidence. I wouldn't give this any FDA sanction, rather tell them go back and do a scientific study. Disappointing. Maybe someone will hack this device for $25. on YouTube
     
  5. VLynx

    VLynx Member

    Just so you know, "FDA cleared device" (which this one is) means almost nothing. It is nothing like approval for drugs. There is no requirement that the device actually do anything useful. This is the definition provided by the FDA:

    "Cleared medical devices: These medical devices are ones that FDA has determined to be substantially equivalent to another legally marketed device. A premarket notification, referred to as a 510(k), must be submitted to FDA for clearance. A 510(k) is most often submitted by the medical device manufacturer."

    Companies abuse this label "FDA cleared" all the time, as customers believe it means that the device has had extensive testing and review and has been proven effective for the use for which it is being marketed. "FDA Approved" devices require a more extensive review (per the FDA: "Approved medical devices: Approved medical devices are those devices for which FDA has approved a premarket approval (PMA) application prior to marketing. This approval process is generally reserved for high-risk medical devices and involves a more rigorous premarket review than the 510(k) pathway.")

    I would guess that the Avacen device got cleared as a heat delivery device for muscle relaxation, like a heating pad.
     
  6. Steve

    Steve Active Member

    Good to keep in mind. "Like a (wtf high priced) heating pad". Jeez, you know how to lower a guy's spirits LOL! Nevertheless, I just noticed they are currently offering a two month trial for 300 bucks if you order before NY. I just kitchen chemistried 100 bucks of one strain of MJ and only got sleepy, with no pain relief. The two other strains also have zero CBD so I have little hope for them either. If I'm going to throw out money I might as well throw it out for a trial of this. My hesitation is long term effects of increasing your blood temperature and reducing viscosity. Anyone have any thoughts about that?
     
  7. Phil Hayward

    Phil Hayward Member

    But would such an approach address the underlying problem (if it is the case) of infection and/or toxic elements? Even if you could somehow force blood vessels to dilate, what if the muscle and myofascia tension and blood vessel constriction are being caused by something physically significant? I would say yes, everything "helps" provided you are doing a wide enough range of self-treatments, to "wind back" the whole syndrome. I don't believe that tricking blood vessels and nerves with electrical signals is a magic bullet solution - it may well suppress symptoms but it would worry me that different damage may occur as a result of the underlying "upset" that triggered the symptoms.

    One thing I might have done better: I lost my considerable excess weight spectacularly rapidly with my protocol but all sorts of symptoms worsened terribly - I believe because the toxins that had been stored in my fat, had to "go somewhere" - and my muscles and organs got swamped and my renal system got overloaded. It was months of hell - perhaps overweight people with fibro need to be more careful about the rate of weight loss. At worst, I was urinating 50 times in every 24 hours, sometimes at 20 minute intervals. I got cramp attacks from hell, crippled with pain for 10 minutes at a time, pain lingering afterwards for a week, never experienced anything remotely as bad in my life before. Upping the magnesium intake to around 5 times "recommended daily", and liberally using magnesium oil externally, overcame the cramping but the excessive urination only started diminishing after about 6 months of it, and nearly a year later I am happily back to normal patterns.

    This is part of the overall condition that I now feel is "over the peak" and everything is now coming together to flush the remaining deposits of toxins and excess elements (lie calcium) away. Supplements claimed to be vasodilators and antioxidants, are probably now having benefit that they might not have before.

    I have followed the dietary recommendations of Interclinical Laboratories (who do the HMAT's), and my naturopath Gary Moller; including getting plenty of sulphur (using Volcanic Black Salt among other things) to help flush out the cadmium that might have been the underlying cause all along. Many toxins have some counterpart element that may be ingested to help the body flush out the toxin.

    As with the Avacen device, I think technology using electric signals to trick the nervous system would be useful as part of a wholistic approach, but I do not yet believe in magic bullets for fibromyalgia.
     
  8. Kate

    Kate Member

    I have severe food sensitivities and the instant I eat too much of a food that my immune system doesn't like, mostly with the chemical salicylate found in almost all plants, I begin to pee very often, sometimes I dribble a bit as well, so not only am I urinating constantly, but I've also lost some control for some reason. So I, too, have experience of the body divesting itself of "toxins" through frequent peeing.

    I completely believe that a machine working on one point of the body can effect such massive change. Our western medicine never developed the understanding of the intricate neurological connections within the body. There are so many examples of body manipulations that effect systems. For example yawning completely calms down the sympathetic nervous system. Another example: I recently began taping my mouth shut at night as part of my Buteyko Breathing protocol. I was surprised to discover I literally slept like an innocent three year old and that this is repeatable. I believe it does something neurological to have something (3m micropore tape in this case) touching the lips, perhaps a hardwired response of relaxation from nursing in infancy. Someone in my CFS forum tried it and had the same results as I did. Then my friend who is well tried it and again experience improved sleep.

    The examples of somatic healing techniques are legion, but in our medical climate they are pushed to the sidelines in order to improve the bottom line. So we pay for insurance then pay for our out of network alternative practitioners as well while unable to pull in income. Don't get me started.

    I bought a Pulsed Electromagentic Field therapy machine called a Bemer and indeed it does help with somatic pain. It is about $4000. now though I got an older model used on Ebay. It took me a year of looking before I finally found a machine and began bidding. Does it help with CFS? The jury is out especially since I am electromagnetically sensitive. Does it help with aches, pains, muscles injuries, swellings and so on? Absolutely. In fact fibro is one of the ailments it is most strongly rated for. After one day of ill advised garden labor (we were cleaning up huge log parts after the public utility cut some of our trees down) I got hideous trigger pints that lasted for months that only dispersed when I used the Bemer. And they dispersed quickly. I don't know what this was, I don't think fibro comes and goes like that, but it was intractable trigger point pain for nigh on four months.

    This is not to say I recommend this new Avacen machine, just that it is possible it works.
     
  9. VLynx

    VLynx Member

    Sorry, didn't mean to roach your buzz! Actually, I think there's a lot of promise in this. Or, I hope there is... I saw the special deal, too, and it intrigues me. Good luck with your money tossing.
     
  10. VLynx

    VLynx Member

    I understand what you are saying. I wasn't referring to "magic bullets" for anything, but rather, future options for pain treatment in general. Treating the pain associated with FMS or CFS is obviously only symptomatic treatment, and I, like you, would prefer to fix the underlying problem. In the meantime, however, I will do what I can to control the pain as long term uncontrolled pain causes its own problems.
     
  11. Cort

    Cort Founder of Health Rising and Phoenix Rising Staff Member

    I think that's a bit harsh but I guess time will tell.
     
    Last edited: Dec 25, 2015
  12. Cort

    Cort Founder of Health Rising and Phoenix Rising Staff Member

    My thoughts as well Phil. I immediately thought of the myofascia when I read about this. My muscles feel so darn tight and constricted with little bits of exercise (or even without them :)). I've got to think that microvascular blood flows come into play here.

    Toxins are something I don't know if there's been any research in at all but are of great interest for alternative health practitioners. It's strange the disconnect there given that those practitioners must be associating reduced toxin loads with improved health in their patients.
     
  13. Cort

    Cort Founder of Health Rising and Phoenix Rising Staff Member

    Thanks for clearing that up. I doubt the Avacen product - which produces negative pressure as well as heat - would get clearance based on a heating pad - which does not produce negative pressure; i.e. a $3,000 device is probably not substantially equivalent to a $30 heating pad and vice versa.

    This is what Ehow says about clearance and approval

    Clearance requests are for medical devices that are exactly like those already on the market. Approved requests are for items that are completely new and need to be inspected for safety in case of new hazards. Both aspects need to be proved or provided by the submitter to ensure proper procedures are followed.

    FDA approval or clearance is necessary to make sure patients using certain medical devices will be safe while utilizing the product. Devices go through rigorous study and examination before being allowed to be cleared or approved into the health care market. It also needs to be proven that the medical device will not only not do harm, but also that it will do good. The entire purpose of a medical device is to improve someone's health, and if the item does not pass that inspection, it will not receive clearance or approval by the FDA.

    It's pretty clear that devices do not undergo the same kind of scrutiny as drugs at the FDA. They must undergo some scrutiny or this device would be approved by the FDA for use in FM. I suspect this is because the device is approved for use in reducing localized pain not widespread pain.


    Read more : http://www.ehow.com/facts_7473426_fda-cleared-vs-fda-approved.html
     
    Last edited: Dec 25, 2015
  14. Cort

    Cort Founder of Health Rising and Phoenix Rising Staff Member

    It's definitely not a high-priced heating pad. Heating pads do not produce negative pressure that pushes blood back into the body. If you apply heat to the body the blood vessels should dilate - sending it back out of the body - not into it. Nor do heating pads come with 3,000 microprocessors. Nor do they cost $2,000. I'm not saying that this works - I've never tried it - but calling this a high priced heating pad is a bit like calling a computer a high priced calculator.
     
    Last edited: Dec 25, 2015
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  15. Cort

    Cort Founder of Health Rising and Phoenix Rising Staff Member

    Interesting about the Buteyko Breathing protocol and the tape! There are too many possibilities that will never get the proper testing to ignore them all.
     
  16. Linda G.

    Linda G. New Member

    I found this pretty interesting, and i wrote to AVACEN 's developers, to suggest them to do a study on PWMEers
     
  17. Steve

    Steve Active Member

    Hey dudes, I know it's not just a high priced heating pad and I'm not offended at people disagreeing about anything with me. I just have used black humor to get through FM for the last three decades!

    An interesting thought that it could mask a more insidious underlying process but if it gets rid of pain by 40% I'll take that risk. As Vlynx pointed out, you are dealing not only with the experience of chronic pain but also dealing with its consequences...for me, marital problems, grossly diminished abilities and quality of life, a retirement which coincided with worsening symptoms. I'm going to read everything this w/e carefully but will probably buy the trial. As I noted, my concern is that they tried this on folks for a month or two and have no LT studies of potential physical consequences. Are there cardiac implications for heated blood and lowered viscosity? Increase of hemorrhage or stroke? Warmer blood in your brain, what does that do? Are we talking of merely raising core temp in damaged folks to that of regular folks? Maybe they answered all these on the web site. But Tramadol, yoga, and Mj are probably not going to get me where I want to be.
     
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  18. Cort

    Cort Founder of Health Rising and Phoenix Rising Staff Member

    Good luck figuring out what to do. Since the device has been used many, many times (they say something like hundreds of thousands of times or something like that) by people with other conditions I imagine that it's safe. Good luck with deciding what to do and if you do try it please let us know - good or bad - how it went. :)
     
  19. Cort

    Cort Founder of Health Rising and Phoenix Rising Staff Member

    Avacen posts this information on their website about the microcirculation:

    Capillary Microcirculation
    The main functions of the microcirculation are the delivery of oxygen and nutrients and the removal of carbon dioxide (CO2). It also serves to regulate blood flow and tissue perfusion thereby affecting blood pressure and responses to inflammation which can include edema (swelling).

    The blood capillaries are where the important functions of the microcirculation take place: the exchange of material between circulation and cells. Capillaries are the smallest of the body’s blood vessels. They are only one cell thick, and they are the sites of the transfer of oxygen and other nutrients from the bloodstream to other tissues in the body; they also collect carbon dioxide waste materials and fluids for return to the veins.
    Microcirculation Capillary Observation
    Introduction: The AVACEN 100 continues to warm the blood passing through the treatment palm, which then circulates throughout the entire body increasing core body temperature. When core body temperature rises, pre-capillary arterioles dilate causing normally collapsed capillaries to open further improving microcirculation throughout the body. This allows excess heat to be dissipated by convection and radiation into the cooler ambient environment until the blood becomes cooler.

    Hypothesis: If the AVACEN 100 is effecting the entire body, then distant capillaries from the AVACEN treatment hand should exhibit increased blood flow (microcirculation) after treatment.

    Materials and Methods: A microcirculation microscope (Shenzhen GH Biotechnology Development Co. model 380, with Cargille immersion oil type A), was used to observe capillary blood flow on the right hand ring finger in an area just below the finger nail (“Before” figure). The left hand was then treated using the AVACEN 100 medical device to infuse heat into the circulatory system for 20 minutes. Immediately following the AVACEN 100 treatment of the left hand, the same capillary area on the right hand was observed (“After” figure). To make sure the same capillaries were observed pre and post treatment, the finger was inserted into the stationary finger holder up to the point where a stop secured to the bottom side of the finger preventing further forward movement. All focusing and platform adjusters remained in the identical setting.

    Results: A significant increase in capillary blood flow in the right hand immediately after AVACEN 100 treatment of the left hand palm was observed.

    Fingernail Growth and Whole-body Microcirculation
    Fingernails reach their peak growth in the second and third decades, with a slight decline thereafter. A possible reason, is decreased blood flow and medical conditions that can affect it — like Raynaud’s phenomenon, which causes a spasmodic constriction of blood flow.
    As the nail receives nutrition from blood flow, new nail plate cells are made. They push older nail plate cells forward extending the length of the nail. In humans, nails grow at an average rate of 3 mm (0.12 in) a month.
    Using the AVACEN 100 has been shown to increase projected fingernail growth by approximately 400% of normal expected growth on both the treatment hand and the opposite hand. This is attributed to the increased microvascular circulation and nutrition initiated by the device.*
    A 56 year old female was used in the pictures below. Only the left hand was used in the AVACEN 100 for a 6 day period. Using recognized nail growth calculations; the average age adjusted nail growth should be approximately 1/10th of an inch for an entire month . The pictures below shows the nail growth on the right hand to be approximately 1/10th of an inch in only 6 days.
    [​IMG]
    * Although not documented, hair growth and thickness appear to increase by approximately 50%.
    DISCLAIMER: Individual results may vary.
    Important Notice: Please read the User Guide which contains information on Intended Use, Instructions, Contraindications, Warnings and Precautions. Both the AVACEN 100 and AVACEN Treatment Method are protected by one or more of the following U.S. patents: 8,679,170; 9,066,781, international equivalents. Other patents pending.

    [​IMG]
    © AVACEN Medical 2015 - All rights reserved.
     
  20. michele

    michele Member

    I have had CFIDS since 1983. About 6 years ago I began to experience severe pain and weakness in my hands and wrists. My hands also became extremely sensitive to cold. The only thing it corolated with was some anti-microbial herbs I was taking to help with horrible stomach pain. Subsequently, somewhere along the way I started taking K2 in an effort to keep calcium in my bones and out of my blood vessels. I guess I've been taking K2 for 1-2 years. I had less hand pain but didn't think much about it. A couple of weeks ago I ran out of K2 and had horrible pain in my hands, couldn't sleep and was horribly sensitive to cold. A couple of days later I started on the K2 again. I had no idea that it is needed for microcirculation. Anyway, for now the hand pain and sensitivity to cold is gone. I have no idea if taking K2 will help anyone else, but thought I'd toss it out there. I take a fairly high dose. It's made by Life Extension.
     
    Last edited: Dec 25, 2015
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