Heat-Therapy Device Studied for Fibromyalgia

Company Launches Crowdsourcing Campaign

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A medical device company says its trials of a dry-heat device show promising results for treating fibromyalgia pain. That led AVACEN Medical to launch a crowd-sourcing fundraiser to pay for further research.

The first question is obviously "Does it work?" However, several other questions come to mind as well:

  1. What about those of us with heat sensitivity and/or thermal allodynia?
  2. Is crowdsourcing a good way to raise money for clinical trials?

    Dry-Heat Therapy for Fibromyalgia

    Heat is certainly not a new concept when it comes to treating pain. Heating pads, hot-water bottles, and microwaved rice bags are probably something most of us have used at one time or another. Hot baths are common among those of us with fibromyalgia, and a fair amount of research suggests that therapeutic exercise in warm water can help us as well. Some people have even explored tanning beds as a way to heat and relax the body.

    However, when considering heat for fibromyalgia, questions come up related to a couple of common symptoms.

    First, let's look at heat sensitivity. Some of us, when exposed to heat or hot environment, develop unpleasant symptoms. These can include:

    1. Puffiness, especially in the hands and feet;
    2. An inability to cool off:
    3. Excessive sweating;
    4. Achiness.

    Some people may need to use things like ice packs and cold water to cool off their bodies once they become overheated.

    The second symptom that raises concerns is called thermal allodynia (thermal = heat related, allodynia = pain from stimuli that normally don't cause pain.) Essentially, this means that heat will cause us pain before it causes a healthy person pain. It seems like this could limit the number of people who are helped by heat-related therapy.

    Of course, no current treatments for fibromyalgia are universally effective, and that doesn't mean we shouldn't explore them and make them available to those who can benefit from them. It just means that we have to tailor treatments to the individual after carefully considering their unique set of symptoms.

    Learn more:

    The Device & The Research

    The device being studied for fibromyalgia is currently on the market. It's called the AVACEN 100, and it is cleared by the FDA as an arthritis treatment. However, it's important to note that the FDA does NOT require devices to go through the same process as drugs. When a device is FDA approved, it means only that it is considered safe. Its effectiveness is not evaluated as it would be with the medication. You can see the device and learn more about it on AVACEN's website.

    The company's research did not appear to be published in a peer-reviewed journal as of early January 2014, but some information on it is available online in a news release.

    According to the release, in a pilot study using daily 10-minute treatments, participants saw about a 16% reduction in pain. In a follow-up study using daily 30-minute treatments, they saw a reduction of just over 40%. The number of tender points, which can be used to diagnose fibromyalgia, saw similar reductions.

    In order to move forward, at the end of December 2014 the company launched a fundraising campaign on CrowdFunder.com, hoping to raise $2 million.

    Crowdsourcing & Medical Research

    Looking to the public to fund medical research is a new and interesting strategy. It allows the average person to support treatments they may be interested in, and that may be a good thing. However, I can see some potential for problems.

    Sometimes, companies aren't able to fund research into promising treatments for reasons that have nothing to do with the medical science. Whether it's politics, controversy, or concerns about how the company is run, investors may hesitate to handover cold hard cash. That can keep good treatments from making it to you and me. Crowdsourcing would be a great option in this case.

    On the other hand, sometimes there's no funding because of poor science, weak study results, or an unethical company. It's difficult for most people to know the difference, especially when the only available information is biased, sounds good to the non-scientifically trained mind, and may be presented along with convincing testimonials. People get roped into paying for quack treatments this way every day. In this case, crowdsourcing could be a real waste of money.

    The bottom line is: be cautious. Be aware of how easy it is to manipulate information and make something look better than it is. Do your own research into the company and its product before you make financial decisions.

    Is it Right for You?

    When it comes to this specific device, the AVACEN 100 is already on the market and considered safe for treating arthritis. That means, if you think it would help you, you can buy it even without FDA approval specifically for fibromyalgia. The lack of approval simply means the company cannot advertise it for that condition.

    As with any treatment, learn what you can and discuss it with your doctor to make sure you're not doing something that could harm you.


    AVISON Medical. AVACEN 100 Heat Therapy.

    PR Newswire. AVACEN Medical Launches $2 Million CrowdFunder.com Campaign in Response to Positive Fibromyalgia Study Results.

    Smith BW, et al. Pain. 2008 Dec;140(3):420-8. Habituation and sensitization to heat and cold pain in women with fibromyalgia and healthy controls.

    Wong F, et al. pain research and treatment. 2010;2010:912513. Extreme thermal sensitivity and pain -induced sensitization in a fibromyalgia patient.

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