Drug side effects and an inability to tolerate many medications leaves most patients with fibromyalgia (FM) in serious pain. The problem is that FM is a disease of the central nervous system, so drugs that work in the brain are bound to produce a greater amount of unwanted side effects. However, Fralex Therapeutics of Toronto, Ontario is testing a novel nondrug device (called the PRIMA) in 12 cities in the United States and four in Canada. The PRIMA is believed to favorably alter the pain processing centers in the brains of people with FM. The goal is to gain the US Food and Drug Administration (FDA) and Canadian government approval to market the portable device for the treatment of FM.

What does the PRIMA device look like? It is a small portable unit designed for in-home or at-work use (see figure below). The heart of the device is a case about the size of a portable cassette player. This handheld portion generates an electric signal that is transferred to a headset that rests just above the ears, where the therapeutic “complex neural pulse” or CNP is created. The shape of the CNP wave-forms and pulse frequency were custom designed to interact with the pain processing centers in the brain. The initial research was performed by scientists at the University of Western Ontario in Canada.

People using the PRIMA simply place the headset upon the head, much as one would wear a set of headphones. A button on the handheld portion is pushed, and the therapeutic waveform is automatically applied to the central nervous system of the patient for the duration of the therapy session, which is about 40 minutes. Two sessions per day are required, but they can be done while the patient is watching TV or doing a light activity (e.g., walking, cooking, working on the computer, etc.). The magnetic strength produced by the device is less than the industry standards for electric hair dryers. It does not make noise, emit light, or produce any sensation that can be felt. Your healthcare provide or pharmacists must program the small prescriber unit for the appropriate treatment settings, similar to a prescription for medication.

Photo provided courtesy of Fralex Therapeutics, Inc.

A recently published study looked at the effects of the PRIMA device in a small group of 17 FM patients.* Eight patients received the therapy twice daily for 40 minutes. The remaining nine patients received what is called a false or “sham” therapy. The sham group took home the portable unit to use for two 40-minute sessions per day, but the device was electronically disabled so that the CNP was not delivered. Remember, the portable unit does not generate any noise, light or sensation, so patients would not know if their PRIMA device was actually working.

Although this was a small study, the FM patients receiving the CNP with the PRIMA device achieved a 25 percent drop in pain scores during the seven-day trial. The sham group did not show any improvement. After the seven-day therapy was halted, the patients who received the actual CNP therapy quickly returned to their before-treatment pain levels. This implies that the daily use of the PRIMA device is necessary, just like medications. If the device meets FDA approval, this should not present a problem because it was designed as a small portable unit.

How much pain relief does one receive with a 25 percent drop in pain scores? The authors of the study cite that 80 mg per day of the opioid, oxycodone, produces roughly the same amount of pain relief in studies of chronic pain patients. Yet, unlike the many side effects that are often accompanied by opioids, safety testing of the PRIMA device in 400 patients did not produce side effects. So, the PRIMA may turn out to be an alternative to opioids, or an add-on therapy to drug treatments for FM patients to bring the pain down to more tolerable levels without adding more side effects.

For additional information about the ongoing PRIMA trials, see the Treatment Studies page of our website.

* Thomas AW, et al. Pain Res Manage 12(4):249-58, 2007.

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