A new medical device, the first of its kind is giving hope for fibromyalgia patients to fight chronic pain without the use of any drugs
Over the years, people suffering from fibromyalgia have been put on various drug-related medical treatments to reduce the widespread chronic pain of fibromyalgia.
Now, fibromyalgia patients have something new to look forward to. Released in 2015, the AVACEN is the world’s first medical device approved by the U.S Food and Drug Administration (FDA) for the treatment of widespread pain.
Fibromyalgia patients typically suffer from joint pain, deep tissue pain, fatigue, depression, headaches and lack of sleep.
What causes all the fibromyalgia symptoms is still a mystery. There are many medical treatments for fibromyalgia symptoms using various types of drugs.
However, Fibromyalgia patients can now treat the chronic widespread pain that the condition causes without using any kind of drugs.
What is AVACEN?
Advanced VAscular Circulation ENhancement (AVACEN), a medical device recently cleared by the U.S. Food and Drug Administration to be marketed for the temporary relief of joint pain.
People suffering from fibromyalgia can fight chronic pain using a single convenient treatment point, the palm of the hand.
The company, AVACEN Medical, released the AVACEN 100 that is cleared by the FDA as a class II OTC (over the counter) medical device.
The FDA also approved the medical device for treating joint pain, arthritis, muscle spasms, muscle relaxation, and minor strains and sprains.
The machine can be used 10 to 30 minutes at a time to feel better. It combines heat therapy and negative pressure to give patients temporary relief from pain.
Fibromyalgia is a medical condition that affects the muscles and soft tissues. It causes chronic muscle pain, fatigue, sleep problems, and painful tender points or trigger points, which can be relieved through medications, lifestyle changes, and stress management.
The cause of fibromyalgia is still not known. However, there are various factors that contribute to it. Some of the may include:
Genetics: This is because fibromyalgia tends to run in families and there may be certain genetic mutations that may make you more susceptible to developing the disorder.
Infections: There are some illnesses that seem to trigger or aggravate fibromyalgia.
Physical or emotional trauma: It is also believed that Post-traumatic stress disorder can lead to developing fibromyalgia and repeated nerve stimulation causes the brain of people with fibromyalgia to change.
This change creates an abnormal increase in levels of certain chemicals in the brain that signal pain (neurotransmitters).
How does it work?
According to AVACEN Medical, the medical device provides muscle relaxation without invasive treatments and treat pain without drugs or supplements.
Patients put their hand into the device in a vacuum chamber. The hand rests on a pad that is heated.
The device continues infusing heat into the circulatory system at normothermia. Infusing heat into the circulatory system reduces blood thickness (viscosity) and increases microvascular circulation.
Thinner blood facilitates more efficient flow through the skeletal muscles on its route to the smaller vasodilated capillaries (microvascular circulation) that the body uses to radiate the excess ATM produced heat into the cooler ambient air.
This increase in microvascular circulation enhances oxygen delivery and nutrition to the skeletal muscles while carrying away the toxins and results in significant benefits for arthritis and muscular relaxation.
The AVACEN 100 uses heat therapy together with negative pressure to leverage the natural adaptations of the body.
This heats the blood temperature ever so slightly and causes your capillaries to expand, blood pressure to lower, and you will feel more relaxed.
Clinical trial results
Not many studies or trials have been carried out at the moment. However, there are a few studies or trials carried out which have shown positive results.
In December 2015, ClinicalTrials.gov, a service of the U.S. National Institutes of Health published the results of the AVACEN Medical’s Fibromyalgia clinical trials.
The 28-day AVACEN follow-up study reported a statistically significant reduction in the widespread pain index and a decrease in tender point count to a level below the value typically used for the clinical assessment of fibromyalgia.
The month long study took place at the University of California at San Diego and involved 22 fibromyalgia patients. The patients carried out a 15-minute treatment everyday.
These results were derived from a treatment process that uses the palm to noninvasively transfer heat into the circulatory system while the body is at normothermia (approximately 98.6° F). This treatment process is referred to as the AVACEN Treatment Method.
The study revealed that the patients reported a 40 percent reduction in widespread body pain.
According to the AVACEN Medical CEO and inventor, Thomas Muehlbauer, these results can significantly improve the quality of life for fibromyalgia sufferers worldwide.
The Company has already submitted the results or data of the study to the FDA to receive approval to market the device for relied of widespread pain associated with fibromyalgia.
Currently, there are no known FDA approved medical devices that treat the chronic widespread pain as a result of fibromyalgia.
In a similar pilot study, 14 fibromyalgia patients were asked to use AVACEN device.All 14 fibromyalgia patients used the device the twice a day.
The results showed that 93 percent of the fibromyalgia patients reported a significant reduction in widespread pain.
However, it is important to note that before starting any new treatment, one must consult your doctor.
This medical device is not recommended for pregnant women and people under the age of 18. It is also cautioned for people who suffer from heart disease, blood circulation conditions or have a high temperature.
Why AVACEN treatment?
While there are different types of medical treatment for fibromyalgia, AVACEN treatment does not use any kind of drugs.
– Easy to Use
– Ideal for In-Home Treatment
– Single Point of Treatment
There are no known side effects of this medical device. The AVACEN 100 has a record of approximately 500,000 treatments without a single reported negative side effect.