BioWave Device Helps Vietnam Vet with Chronic Pain

By Pat Anson, Editor

A few months ago, Vietnam veteran Gregg Gaston was depressed and suicidal. Gaston shared his story with PNN readers in a guest column, telling how he suffered from years of chronic pain caused by a failed back surgery, peripheral neuropathy and post-traumatic stress syndrome (PTSD).

Despite his pain, Gaston’s doctor told him he was being cut back to a single dose of tramadol, a mild opioid analgesic. That was the last straw for Gaston, who at the age of 62 was fed up with debilitating pain and doctors who no longer wanted to treat it with opioids. In protest, Gaston fired his doctor and refused to fill his last prescription for tramadol.

GREGG GASTON

GREGG GASTON

“I've given up and am waiting now to die. I've lived a great life and have no expectations of my quality of life improving,” Gaston wrote.  “Common sense is fast disappearing. I'm done fighting.”

Fast forward three months and there’s been a remarkable change in Gaston’s mood and quality of life. The folks at BioWave, a Connecticut medical device company, saw Gaston’s column and sent him one of their neurostimulation units, which use high frequency electrical impulses to block pain signals.

“I was skeptical at first. I really was,” Gaston says. “Being at the breaking point and feeling desperate, I was only too eager to try it. And for me, it really works. I’m not 100 percent pain free, but I can get out of bed in the morning. It’s great, it really is.”

Before he started using BioWave, Gaston says his pain level was usually a 7 or 8 on the pain scale. Today, even on a bad day, it’s only a 3.

“If you have chronic pain you know what a difference that is,” he says. “I used to often sleep no more than 2 hours at a time, now I often sleep through the entire night.”

Think of BioWave as a more advanced version of a TENS unit. Electrodes wired to a battery and control unit send two high frequency signals through the skin into deep tissue, where they stimulate blood flow and block pain signals.

Each treatment takes 30 minutes, and the pain relief can last anywhere from a few hours to a few days, depending on the patient and their condition.  

“I started using it several times a day. But as I got feeling better in my back, I dropped it down to once a day. Now it’s once every two or three days,” says Gaston, who takes no pain medication outside of an aspirin. “They saved my life. My quality of life is still not great, but it’s better than what it was.”

BIOWAVE IMAGE

BIOWAVE IMAGE

BioWave has been around for a few years but is not widely known. It was first used by professional sports teams to treat athletes with sprains, tendonitis, muscle pain and other injuries. When it proved effective in treating chronic pain, dozens of pain clinics and VA hospitals started using BioWave devices.

BIOWAVE IMAGE

BIOWAVE IMAGE

“Most of the treatments deal with chronic pain and I would say the majority deal with lumbar and cervical pain. That’s probably the bread and butter for our device, but certainly any extremity pain in the shoulder, elbow, elbow, wrist or ankle. We can really treat almost any location on the body,” says Brad Siff, BioWave’s founder and president.

The company says over 75% of patients respond to BioWave treatment, with a significant improvement in their pain scores, mobility and stiffness. The device can even help patients with complex conditions such as arachnoiditis, a chronic and incurable spinal disease.  

“There’s a handful of anecdotal data that we have where arachnoiditis patients have responded. Similarly, patients with failed back surgery have been treated with BioWave and it helped them," Siff told PNN.

"I’m not saying it reduces their pain 100 percent, but some may get a 30, 40, 50 percent reduction in their pain and it lasts for a long period of time following the treatment."

BioWave is currently available only by prescription, but later this summer the company hopes to get FDA approval for a wearable over-the-counter home unit that can be purchased directly by patients. The final pricing hasn’t been determined, but Siff expects it to be between $300 to $400.

For more information, you can visit BioWave at their website by clicking here or by emailing them at info@biowave.com.

Wear, Tear & Care: Rating Omron's Avail TENS Unit

By Jennifer Kilgore, Columnist

I don’t use TENS units very often. Since I wear the Quell on a daily basis, it usually seems superfluous -- unless I’m having a very bad day.

Then my TENS unit makes an appearance, wires snaking under my shirt and sticky pads placed wherever I can get them. The power pack is latched to my pants, and the result is that I feel like a moron. Even if there is nobody at home to witness my treatment, I become self-conscious. My cat has an opinion, I’m sure.

That’s why I was excited to try the Omron Avail TENS device. It’s wireless, has two large pads, and can be controlled from my phone. There’s no bulky battery pack to wear on my belt, no wires tangling me, and the pads themselves are larger than the unit I currently have. The coverage of more bodily real estate is always a winner for me.

The Avail TENS is a wearable electrotherapy device that is designed to alleviate chronic muscle and joint pain. It has various pre-programmed settings designed for the shoulder, arm, back or leg; as well as modes that include both TENS and microcurrent, the latter of which applies electrical stimulation that one can hardly feel. The TENS modes are much stronger in sensation.

IMAGE COURTESY OF OMRON

IMAGE COURTESY OF OMRON

I actually didn’t know that microcurrents were used in pain relief -- I thought they only applied to anti-aging treatments at spas. However, this therapy mimics the body’s natural currents, which are believed to restore normal frequencies within cells.

I don’t know how well the microcurrent mode works yet, because I still experienced pain when I tried it.  I imagine it takes some getting used to and that benefits accrue over time. However, the TENS mode works wonderfully, and having such large pads means that I can get more coverage.

Treatment sessions run between 30 and 60 minutes, depending on the mode chosen. You can also set sessions to run indefinitely. To charge the sensors, they must be placed on a special charging box that comes with the device. I’ve managed to use it multiple times now after the initial charge.

IMAGE COURTESY OF OMRON

IMAGE COURTESY OF OMRON

It is very easy to set up and use, as most of it is intuitive for a chronic pain patient. The device must be paired with your smartphone, and the app is fairly straightforward. The only thing that kept happening to me was that the pads would unlink with the app because I kept pressing the power button on the pads by mistake -- for instance, when I leaned back on a couch.

The pads stay on well. The "help” section of the app states I can use them up to 30 times, and replacement pads range from $12.75 to $19.99. I might resort to using athletic tape to keep them on longer, as I do with normal TENS pads. I know that isn’t advised, but I want these pads to last as long as possible.

So far, my only complaint is the slight bulkiness of the pad itself. Having a wireless device means that a sensor must be placed on the pad, which ties it to the app. These blink in orange or green lights, which are even visible from underneath two shirts. Granted, clothing manufacturers have been making clothing thinner and thinner so you are required to buy more clothes, so maybe that’s not Omron’s fault. There’s even a name for this clothing phenomenon: “planned obsolescence.”

Additionally, since my problem areas are on my back, sitting in a chair can be awkward. The pads stick out and rub against the seat, which turned them off once or twice. I don’t think the unit is meant to be worn all day, though, unless one plans to use microcurrents alone. The company only recommends that three TENS treatment sessions be completed on a daily basis.

My overall impression is a good one. I like the device, and I think it works well. It controls my pain when I use the TENS settings. I just wish the sensors on the pads were thinner -- that would help my back-pained compatriots (and me) when leaning back into a chair. That seems like a small complaint for such a device, though.

The Omron Avail is currently on sale for $159.99 (normally retails at $199.99). 

JW Kain.jpg

Jennifer Kain Kilgore is an attorney editor for both Enjuris.com and the Association of International Law Firm Networks. She has chronic back and neck pain after two car accidents.

Jennifer receives products or services mentioned in her reviews for free from the manufacturer. She only mentions those that she uses personally and believes will be good for readers. You can read more about Jennifer on her blog, Wear, Tear, & Care.  

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

New Wearable Devices for Chronic Pain

By Pat Anson, Editor

With opioid pain medications becoming harder to get and many patients looking for safer alternatives with fewer side effects, a growing number of companies are offering wearable “electrotherapy” devices for pain relief.

There’s the Cefaly headband for migraines, ActiPatch for sore muscles, AcuKnee for osteoarthritis, and the Quell nerve stimulator, which is designed to treat a range of chronic pain conditions. All are part of a fast growing $2.8 billion market for wearable medical devices.

“There’s a big problem brewing on the horizon. And that is the pain medications are being removed from the market, slowly but surely,” says Phillip Muccio, President and founder of Axiobionics, which has been making customized electrotherapy devices for 20 years.

“Electrical stimulation has a way of reaching into the body and interacting and coordinating what happens to the body. That’s why it a fascinating area of medicine because not a lot of things will do that, especially non-invasively and non-pharmacologically.”

Most of the new devices use a form of electrical stimulation to block or mask pain signals – a technique developed decades ago known as Transcutaneous Electric Nerve Stimulation (TENS).

Unlike the old TENS units, which are typically used for about 30 minutes, wearable devices are designed to be worn for several hours at a time or even while sleeping.

image courtesy of axiobionics

image courtesy of axiobionics

“TENS is like a short acting opioid. It’s basically only effective when it’s on,” said Shai Gozani, MD, President and CEO of Neurometrix. “If you’re going to deal with chronic pain, you have to have a wearable, chronically usable device, because pain can be two hours a day or it could be 24 hours a day. TENS devices historically haven’t been designed at all for wear-ability or continuous use.”

Neurometrix recently introduced Quell, an electrotherapy device that Gozani compares to a spinal cord stimulator. But instead of being surgically implanted near the spine like a stimulator, Quell is worn externally on the upper calf below the knee.

image courtesy of neurometrix

image courtesy of neurometrix

“We really look at spinal cord stimulation as the model. We’re trying to make that available but in a non-invasive, wearable way -- versus TENS devices which are really intended for local muscle stimulation. We don’t stimulate the muscles, we stimulate the nerve alone,” Gozani told Pain News Network.

“The upper calf has a lot of nerves. It’s comfortable. It’s discrete. So it meets the requirement to have a large segment of nerves to stimulate, but it’s also highly usable from a wear-ability perspective.”

A small study recently conducted by Neurometrix found that over 80% of Quell users had a significant reduction in pain and two-thirds were able to reduce the amount of pain medication they were taking.  Participants in the study had several different types of of chronic pain, including fibromyalgia, sciatica, neuropathy and arthritis.

When it comes to clinical studies, medical device makers have a clear advantage over pharmaceutical companies, which often have to spend years and tens of millions of dollars proving the safety and effectiveness of their drugs before they’re approved by the Food and Drug Administration. Device makers are held to a lower regulatory standard.

“Devices are approved by FDA basically for safety and not necessarily for efficacy. It’s a lot easier to demonstrate that with a device than if you have to demonstrate a new drug. You basically run one study or two and show that nobody got electrocuted by a TENS unit and you’re good to go,” said Bob Twillman, PhD, Executive Director of the American Academy of Pain Management.

Device makers can even get fast track approval from the FDA without any clinical studies -- if they say a new device is substantially equivalent to an older device already on the market.  Quell, for example, was given clearance by the FDA because of its similarity to Sensus, another Neurometrix device that's worn below the knee for pain relief.

A significant disadvantage for device makers is that most are not covered by public or private health insurers – meaning patients have to pay for them out of pocket. Three years ago, Medicare stopped covering TENS for low back pain, saying the technology was “not reasonable and necessary.”

The lack of reimbursement also makes many doctors unwilling to prescribe wearable devices and unfamiliar with the technology behind them, which stifles innovation.  For that reason, Neurometrix took an unconventional path and made Quell available without a prescription – bypassing insurers and doctors so it could market directly to consumers for $249 a unit.

“We thought it was imperative to get it over the counter. We wanted to make sure it was accessible to patients," said Gozani. "Wear-ability changes everything. Wear-ability is the game changer in terms of optimizing pain relief. I think it's huge."