Wear, Tear & Care: The ActiPatch

By Jennifer Kain Kilgore, Columnist

Loyal readers, I have returned.

It’s been a tumultuous month of bad days and flares, so while I was absent from my writing duties, I was trying out a hodgepodge of products designed to offer pain relief.

Naturally, none of them worked. Let’s discuss.

A while ago it was suggested that I try the ActiPatch. I was originally introduced to this new form of pain product by Lil’ Bub, the celebrity cat.

I should probably explain that.

Lil’ Bub, full name Lillian Bubbles, is a perma-kitten, meaning that she will retain her kitten-like characteristics for her entire lifespan.

She also has an extreme case of dwarfism and a rare bone condition called osteopetrosis (the only cat in recorded history to have it), which causes her bones to become incredibly dense as she grows older. This causes pain and difficulty when she tries to go from Point A to Point B.

Her person, called the Dude (like Jeff Bridges in “The Big Lebowski”), discovered the Assisi Loop, which is designed to treat pain and inflammation in pets. The device uses targeted PEMF technology (or pulsed electromagnetic fields) to induce healing within the area of the plastic “loop.”

IMAGE COURTESY LILBUB.COM

Before starting her treatment, Lil’ Bub was becoming stiffer and less mobile.  But two years of therapy later, she's running, jumping, and acting like any other cat.

Fast forward to the present day and the explanation as to why I am talking about a cat. ActiPatch is the version of this for humans. I received a letter and package from the president of BioElectronics that contained a thick wad of research and loops for my back, knees, and muscles/joints. I tossed the ones aimed for knees to my husband and kept the rest for myself. Because I’m selfish.

The ActiPatch loops manipulate the body by means of electrical signals, much like TENS devices. The field created within the loop “induces an electrical field in the target tissue,” as  Andrew Whelan stated in his letter to me. These fields affect nerve fibers and cellular function by increasing blood flow and decreasing inflammation, thereby reducing pain.

Additionally, as Mr. Whelan said, the field is “periodically amplified by the background energy within the target tissue, a process called stochastic resonance.” This is when unpredictable fluctuations, or “random energy,” cause an increase in the signal transmission.

During their “Try and Tell” rollout campaign in the U.K. and Ireland, more than 5,000 responded to a survey of trial devices that were sent to interested individuals for only the cost of postage. The company claims there was a “consistent response” of 52 percent reporting sustained pain relief.

Back in my world, I encountered a few problems when trying out the ActiPatch. My pain, as I have mentioned before, is both widespread and diffuse. There are specific areas of genesis, but the pain is by no means contained to just my spine. I have injuries to my cervical, thoracic, and lumbar spine, but the sections with the “loudest” pain tend to be my shoulders, the sides of my neck, my ribs, and my low back. These loops, which are only about the size of a small plate, could not possibly reach all these spots. I’d look like a rubber band ball.

During my trial run, I decided to place the loops both in the “genesis areas” (IE, over my spine directly) and on my shoulder blades. Getting the loop to fit over the curve of my trapezius muscles was difficult. The loops came with a box of Band-Aid-like stickers to hold the loops in place, and I made quite the mess attaching all of them to my skin. Once the loops are placed, however, you simply press a button on the little magnet, a green light comes on, and off you go.

I pulled my shirt on over everything and encountered another issue: the green lights of the loop batteries showed through my shirt, as did the loops themselves. I looked like an undercover informant with poorly-hidden wires. The mafia would surely figure me for a rat. The solution: many layers!

The day I chose for my test run was a normal weekend day. I hadn’t planned anything strenuous and no activities were going to be out of the ordinary. I didn’t wear my Quell, and I also left off the roll-on Stopain that I usually slather on every day. I wanted a day where I could control the variables in order to test the efficacy of the device. My husband and I ran our weekend errands and then decided to take a short walk out in nature. 

My first observation: I did not feel anything from the devices themselves. Others who have used the ActiPatch have told me they felt the sensation of heat within the area of the loops. I didn’t feel anything. I have decreased sensitivity in many areas of my body anyway, so that was not surprising. Additionally, the ActiPatch website states that there will be no sensations.

My second observation: The areas outside of the loops hurt more than normal. I don’t know how good the devices are at affecting areas other than what is in the confine of the loop. The space within those circles felt like a black hole, which is better than pain. While something was definitely going on in the loops -- when I took them off at the end of the day, those areas were red, appearing almost sunburned -- I don’t feel like it helped my widespread pain to any significant degree.

My third observation: I ended up crashing far earlier than normal. By early afternoon I was in my recliner and taking heavier medication.

My hypothesis: The ActiPatch device is probably great for somebody with an injury that is clearly restricted to a certain area. For instance, my husband hurt his knee while running. The loop would be able to focus on that since the pain does not radiate out all over the body.

For somebody like me (an anthropomorphic bruised banana), the loops are far too small. I would need a hula-hoop-sized device in order to make a dent in my daily pain.

J. W. Kain is an attorney in the Greater Boston area who also works as a writer and editor in her spare time.  She has chronic back and neck pain after two car accidents.

You can read more about J.W. 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

“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

“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."