Regrettably, this CBS News broadcast sounds more like an infomercial than a news report. It describes a “new” device that delivers electrical signals to the skin through a one and a half-inch patch containing more than a thousand tiny needles. The broadcast says that invisible electrical waves “penetrate the nerves and seem to interrupt pain signals—blocking them before they reach the brain.” The story cites “preliminary research” that purportedly shows that the nerve stimulation device “reduced pain quickly and significantly.” But it does not quantify the benefits in either a relative or an absolute frame. How much is “significant”? Moreover, there is no mention of the quality of the evidence—other than that it is preliminary. Is the broadcast referring to small randomized trials that compared the device to a placebo, with subjects and researchers who did not know who received which treatment? Or does “preliminary” simply mean that some people received treatment and said they felt better? It is impossible to know. The story says the device is “new,” but that isn’t completely accurate. According to the FDA’s August 2006 approval letter, it is “substantially equivalent” to TENS (transcutaneous electrical nerve stimulation) devices which have been in use for more than 30 years. The difference is that the newer unit described in the broadcast uses an electrode with tiny needles instead of a standard surface electrode. The addition of needles to a TENS unit is a more recent innovation (but not new), and often marketed as “percutaneous” electrical nerve stimulation devices, or PENS. Interestingly, the story is one among a series of broadcasts titled “Boomer Bodies,” presumably planned with some lead time. The absence of a truly skeptical source to balance the enthusiasm of the story’s primary sources—two patients and a physician who are Biowave proponents—is all the more lamentable. In essence, this broadcast describes a treatment that is expensive, poorly studied, short-lived if effective, and aimed at vulnerable people living in chronic pain. So why is it so gung-ho?
The story says that the treatment—“for people who’d try anything to make the pain go away”—costs about $300 per treatment and typically is administered during 6 sessions, “one every day or two.” But it says nothing about the costs of a multitude of other treatments for low back pain.
The story sums up the benefit by saying merely that the nerve stimulation device “reduced pain quickly and significantly” in “preliminary research.” It makes no attempt to quantify this benefit in relative or absolute terms.
The story says the device is noninvasive (attaching to the skin with patches) and “appears to be safe.” But no evidence is cited. Some might say that it is potentially harmful for a person in pain to spend $300 on a treatment whose apparent benefits lasts a mere 24 hours (the duration of benefit cited in the FDA’s approval letter).
The broadcast cites “preliminary research” that purportedly shows that the nerve stimulation device “reduced pain quickly and significantly.” There is no discussion of the quality of this evidence. Is the broadcast referring to small randomized trials that compared the device to a placebo, with subjects and researchers who did not know who received which treatment? Or does “preliminary” simply mean some people received treatment and said they felt better? It is impossible to know. Evidence to support the use of other electrical nerve stimulation systems for chronic pain is not very strong.
Although it’s a little unclear, this story seems to suggest that the nerve-stimulation device is designed to treat common back pain, leg pain, and/or arthritis. For example, the golfer-patient has “nagging” back pain purportedly caused by arthritis, a disease said to afflict some “20 million Americans.” One of the doctors interviewed says, "This is one thing that gives us an option to try and help millions of people." The story makes no mention of the fact that many such aches come and go on their own with no treatment at all. In addition, it fails to note that the device has been approved for use in a very narrow group of people—those with “chronic, intractable pain, [and] post-surgical and post-traumatic acute pain.” Instead of reassuring people, the story nudges them to seek an uNPRoven, expensive treatment for vaguely defined aches and pains.
The story is thin on balance, citing one physician and two patients who are unabashed proponents of the technology (and a fourth source who points out that “There is no golden bullet” for arthritis). The broadcast could easily have found an evidence-based observer to provide a skeptical critique of this therapy.
The broadcast notes that there are many treatments for osteoarthritis, but it only mentions narcotics and surgery in passing. (In a closing discussion with CBS News anchor Katie Couric the reporter also dismisses glucosamine). Depending on the site of the arthritis or chronic pain, nonsurgical treatments include nonsteroidal anti-inflammatory drugs, physical therapy, intensive strengthening and rehabilitation, hot pads, assistive devices such as canes and braces, capsaicin cream, and others.
The broadcast cites a physician who has treated more than 100 patients with the so-called nerve-stimulation device, but it says nothing about the device’s wider availability. Is the device FDA-approved? If so, for what—chronic back pain, osteoarthritis, something else? According to a document on the FDA’s web site, the device is approved for the treatment of “chronic, intractable pain, post-surgical and post-traumatic acute pain, and symptomatic relief of post-operative pain.”
The broadcast says the device is “new,” but that’s not completely accurate. The Biowave is really a repackaging of an old idea. According to the FDA’s August 2006 approval letter, the device is “substantially equivalent” to TENS (transcutaneous electrical nerve stimulation) units that have been in use for more than 30 years. The addition of needles to a TENS device is a more recent innovation (but not new), and often marketed as “percutaneous” electrical nerve stimulation devices, or PENS.
No obvious use of text from the press release.