Patient enrollment has started at Henry Ford Hospital (Detroit) for a trial of Ivivi Technologies' (Montvale, New Jersey) targeted pulsed electromagnetic field (tPEMF) technology for the treatment of knee osteoarthritis.
Electrical nerve stimulation has been used for decades for pain relief, as an alternative to drugs. Ivivi's 100-patient trial is designed to determine not only if tPEMF is effective in reducing pain and improving function people with pain, but also to accelerate the rate of healing.
"The design of the signal [emitted by the tPEMF device] is all-important," David Saloff, Ivivi executive VP/chief business development officer, told Medical Device Daily. "[The] new signals we've developed are meant to optimize and make the anti-inflammatory response more robust. All we're doing is enabling the body to use all of its bandwidth. If it's there, we can accelerate the rate of healing."
The as-yet-unnamed tPEMF device, dubbed an electroceutical, is battery powered and looks like an elongated coffee cup saucer attached to a strap with Velcro closures. Patients take it home and wrap it around their knees twice a day.
The IRB-approved trial at Henry Ford Hospital is designed to determine if Ivivi's tPEMF is effective in reducing pain and improving function for persons with knee dependent full-time employment who have early to moderate knee osteoarthritis. The specific aim of the study is to evaluate the effects of tPEMF treatment, with two 15-minute applications daily, on pain and function over two-, six-, eight- and 12-week intervals. The study is anticipated to continue for up to 18 months.
However, if the data are positive early on — specifically after six weeks — Ivivi intends to submit an application for review by the FDA.
While the tPEMF could, in theory, have numerous applications, knee osteoarthritis was chosen because, Saloff said, so many auto factory workers near Henry Ford Hospital are on their feet all day and suffer from knee arthritis.
The Centers for Disease Control and Prevention (Atlanta) has reported that almost one in five U.S. adults, or 46.4 million people, have arthritis, the nation's most common cause of disability, with osteoarthritis the No. 1 form of the disease. Knee osteoarthritis is expected to affect nearly 28% of adults over the age of 45 and over 37% of adults over the age of 60.
"In the first phase of the study, we'll see if we can we affect the pain," Saloff said. "Preliminary date indicates results comparable to non-steroidal anti-inflammatory drugs in terms of immediate pain relief. The second phase of study is to see if we can have a rehabilitative effect on the knees."
The tPEMF is currently being reviewed as an adjunct to other arthritis therapy, but "ultimately, we believe it would be a stand-alone therapy. The principal investigator at Henry Ford cited the American Heart Association's statement that said physicians worldwide should seek any alternative to NSAIDs for patients who have risk factors associated with heart disease and that's 90 million people," he said.
The principal investigator of the study is Fred Nelson, MD, director of the Osteoarthritis Center at Henry Ford and past president of the Society for Physical Regulation of Biology and Medicine (Frederick, Maryland).
Although Saloff said his company had not yet developed a commercialization plan even though data could be ready for FDA review within the year, he did reveal that Ivivi is in the midst of "a very significant conversation with a pharmaceutical company" for outlicensing of the electroceutical therapy.