Healthy Living

Health Canada Gives Approval on AVACEN 100 for Fibromyalgia Treatment

Health Canada Bestows Approval on AVACEN 100 for Fibromyalgia Treatment

Health Canada, which is a federal department in charge of assisting Canadians with obtaining quality healthcare and promoting healthy lifestyle practices, just gave its approval for the licensing of the AVACEN 100 Class II to be used in the treatment of fibromyalgia, which afflicts about 10 million people in the U.S. alone according to the National Fibromyalgia Association.This is most welcomed news to patients and practitioners alike who are looking for supplemental treatments or replacements for the current therapeutic options.

A New Alternative to Medication

Before the approval of the AVACEN 100, the main route of treatment included drugs, such as Cymbalta, Lyrica, and Savella. All of these address the widespread, severe pain, but over time, might diminish in pain relief due to the body’s increased tolerance. Likewise, there are numerous side effects that raise concerns with each of these medications:

In addition to these medications, doctors also prescribe non-narcotic pain relievers, like tramadol, mild doses of antidepressants, or benzodiazepines. For persistent joint pain, a lidocaine injection can be given periodically. Additional options for pain relief include regular exercise and stretching.

Of course, every patient responds differently to medication or to any given treatment method, but one more alternative to fall back on can be beneficial in the long run, especially given the consideration that fibromyalgia still remains rather obscure in relation to its cause which makes effective and focused treatment quite a challenge to achieve.

The AVACEN Method

The AVACEN 100 is a medical device that employs the Avacen Treatment Method, which involves a noninvasive process of treating chronic pain by safely introducing heat to the circulatory system to promote muscle relaxation and to increase microcirculation. Another distinct trait about the AVACEN 100 is that it relieves pain throughout the entire body and not in just one specific area.

The device and its system of treatment are quite simple yet effective. The device combines heat therapy with negative pressure to infuse heat slowly and safely into the veins and arteries in order to increase local circulation. As a result, the blood temperature is raised naturally by way of the circulatory system.

The pain relief is acquired by the patient placing his or her hand into the AVACEN 100 for a 10 to 30 minute treatment depending on the severity of the symptoms. The screen displays instructions, or the patient can leave the device on its default setting which allows for just a push of a button to start the therapy.

The method of therapy comes through the AVACEN Treatment Method, which entails a chamber controlled by a microprocessor that envelops the hand with negative pressure that’s very slight. The heat is gradually added to the palm at the same time as the pressure is being applied. This occurs because the pressure to the palm increases blood flow through the veins in this area. The heat, in turn, is transferred from the treatment pad to the vascular network in the palm whose expansion facilitates the circulation of the heat, thus alleviating pain and discomfort in a non-invasive manner.

This action differs from using a heating pad or a hot water bottle because when the body is exposed to heat from an external source, its natural protection mechanism is to constrict the vascular network to prevent overheating. Conversely, the AVACEN 100 does the opposite by applying the negative pressure to slowly and safely infuse the heat whose transfer is regulated by the device.

The Study that led towards Approval

Approval was given after a Phase 2 study was conducted on fibro patients over the course of 28 days. A total of 29 patients were selected for the study who ranged in age from 21 to 76. Upon enrollment in the study, they were trained by physicians to use the AVACEN 100. They were also advised not to start, stop, or change treatments other than taking on the routine associated with the device.

The subjects were then placed on a regimen of using the device once a day for ten minutes. This served as the pilot study, and the outcomes were measured by tender point exams, given by the doctors, and a self-assess rating of widespread pain. The assessments were given before and after the treatment period. The results of this pilot showed a reduction of pain and related symptoms.

Then, a follow-up study was conducted for another four weeks. This time, the subjects were instructed to use the AVACEN 100 for 15 minute twice a day. Just like before, both doctors and patients reported significantly less pain. For both studies, the patients performed the therapy using the device at home.

Aside from measuring instances of pain relief as well as to what degree, doctors also looked for a lessening of the severity of depression (often associated with fibromyalgia) and changes in pain perception. Again, positive observations were recorded, and subjects reported a better quality of life. And interestingly enough, no adverse side effects from the heat were described. Overall, the patients fared quite well during the period of treatment.

Positive Aspects Discovered in the Study

What is also worth looking at are the specific types of symptoms that were affected by the AVACEN 100 in a positive manner. The cohort was divided into two groups—Group A, which consisted of five patients, and Group B, which consisted of 14 patients.

  • Widespread pain index: 3 out of 5 participants in Group A reported improvement; for Group B, 13 out of 14 reported less pain also with an average of 44% giving positive feedback
  • Symptom severity score ratings: 2 out 5 in Group A and 8 out of 14 in Group B reported less severe symptoms
  • Tender point count: (Keeping in mind that some data was lost from Group B) Two out of five participants from Group A reported a lower rating as well as eight out of 14 for Group B; this marks a significant improvement even still
  • Ratings for somatic symptoms: (Again, looking less severe) One out of five and nine out of 14 reported improvement from Groups A and B respectively
  • Severity of fatigue: For Group A, 1 out of 5 reported a decrease in fatigue; for Group B 6 out 14 reported improvement
  • Severity of cognitive symptoms: For Group A, 2 out of 5 reported a decreased severity scores; for Group B, 6 out 14 saw less severity
  • Average weekly pain intensity: Group A’s 3 out 5 participants reported less pain while Group B’s 8 out 14 also had positive results.

So looking at the overall big picture of the different types of symptoms, one can see that this device would serve well in the treatment of fibromyalgia. Likewise, it impacted the quality of life in patients by lessening the severity of the symptoms when used on a regular basis. Furthermore, being that no medication is involved in using this device, it did not produce any adverse effects with any other prescriptions. Therefore, this device could open the door to other possibilities in the realm of pain management.