鈥淭ake a few steps just to make the Devil mad! Hallelujah! That鈥檚 it, just move around a little bit, there she goes!鈥� Those were by televangelist and soon-to-be-exposed-as-a-fraud Peter Popoff, as he allegedly channelled divine power to cure a woman of her arthritis. She no longer needed her walker and was able to take a few steps, though not without holding for dear life to Popoff鈥檚 hand.
Pain is a common symptom of existence. Whether we look at or , it is estimated that one in five people has chronic pain.
But pain is also a slippery devil. With the pressure of a thousand stares at an event, combined with desperation and a religious faith in divine salvation, our temporary perception of pain can be drastically altered. I would love to see if this woman really did kiss her walker goodbye after Popoff鈥檚 intervention. I can guarantee you she did not. But in the moment, her pain probably did go away or was made more manageable.
The experience of pain is so subjective that it does lend itself to be influenced by non-specific placebo effects. If you really believe an ancient herb or state-of-the-art gadget has the power to take your pain away, you might feel like your pain recedes, at least in the short term.
Given how many of us experience pain regularly, it鈥檚 no wonder that so many products are sold claiming to relieve us of our burden, especially given the limitations and pitfalls of pharmaceutical options. Despair turns patients into customers. 鈥淲hat if it does work?鈥� we ask ourselves.
For 119 dollars (minus shipping), you can buy a rectangular adhesive patch that looks like a giant computer microchip鈥攁 鈥渕acrochip,鈥� if you will. It鈥檚 called and the promotional images on promise a painless state 鈥渋n under 60 seconds鈥� with a product that is 鈥�100% drug-free and [has] zero side effects.鈥�
You apply the reusable Kailo patch on your body between the pain and the brain and voil脿! The patch takes away the pain. And it has even been tested in a clinical trial!
Do the claims add up?
Mind the gap
The Kailo patch is said to work anywhere on your body to 鈥渜uickly turn off pain in your head, neck, shoulder, back, knee, hand, foot, and more,鈥� and it claims to do so, not by transferring a drug through the skin or by applying an electrical current, but by 鈥渉elping the brain communicate with disrupted areas more effectively.鈥�
It looks to me like the makers of the patch don鈥檛 know for certain how it works, but they have put forward a proposed mechanism of action which sure sounds scientific. It involves words like 鈥渃apacitors,鈥� 鈥渘ociceptive signals,鈥� and 鈥渄ysfunctional axons.鈥� Essentially, the Kailo patch, which has no power supply of its own, is supposed to soak in the body鈥檚 鈥渁mbient energy鈥� and direct it back at the body, acting as a bridge between the painful area and the brain, which processes pain signals. We are told these signals get naturally distorted, and the patch restores proper communication so that the brain can help the body heal itself.
I reached out to two pain experts to get their takes on this proposed mechanism of action.
Dr. Greg Weir, a senior research fellow at the University of Glasgow鈥檚 Centre for Neuroscience, wrote to me that pain is caused by increased electrical activity in the nerves dedicated to sensing it. The proposed mechanism behind the Kailo patch is 鈥渢otally inconsistent with what we know about pain neurobiology.鈥� We feel pain because our brain communicates a little too well with the part of our body sensing the pain. There is no need to bridge the gap and improve communication here. Quite the opposite, in fact: local anesthetics work by turning off the electrical activity of our pain-sensing nerves.
For Dr. Robert M. Caudle, a professor at the University of Florida College of Dentistry whose research programme focuses on pain transmission, the idea that the Kailo patch acts as a bridge to enhance communication between the pain and the brain 鈥渞eeks of truthiness and has no substance.鈥�
The patch is said to be made up of billions of incredibly small particles鈥攏anoparticles鈥攐f silver and copper that act as little capacitors, meaning they can store an electrical charge. I could not find evidence that the patch actually works in the way it is described: that it gobbles up energy from the body, stores it, and is able to send it back. This is a measurable claim, yet where are the measurements? And what good would it do to draw energy from the body and send it back? And what energy? Electrical charges in your body, as ? Or something more arcane? Because this whole notion of a breakdown in communication causing illness reminds me of the boogeymen of acupuncture and chiropractic, where a mysterious life force is impeded from flowing like a river. The frequent claim that Kailo is and is also sounds like an appeal to the 鈥渁lternative medicine鈥� crowd. If the patch were chemical free, it would not exist, as every component of this patch, including the silver and copper, are chemicals.
Dr. Caudle mentioned to me that one of the biggest problems with pain is 鈥渢he huge placebo effect.鈥� Surely, this is the kind of effect that could be controlled for in a robust clinical trial, pitting the real patch against a fake patch devoid of nanoparticles, or applying the real patch on the wrong part of the body.
While a clinical trial was conducted, its methodology is a head-scratcher.
Trial and errors
The trial that tested the Kailo patch was called , which was financed by the distributors of the patch and run by a research company called .
One hundred and twenty-eight adults with different types of pain were given the Kailo patch for 30 days, while 20 adults with pain served as controls: they were put on a waitlist for 30 days, and then received the patch for 30 more days, having crossed over to the treatment arm of the trial. (By the way, don鈥檛 let the and fool you: there was no placebo arm in this trial.) The reported results are pretty astounding. The first group鈥檚 pain levels go down significantly, while the control group鈥檚 levels go up without the patch, only to decrease strongly when using the patch. There were no side effects reported, and 91% of participants said they were now using less (sometimes a lot less) oral pain medication because of the patch. It sure sounds like a homerun.
But I noticed some issues with the trial. A control group needs to be equivalent to the treatment group in all measures. This means that the proportion of men and women or the age distribution, for example, should be roughly the same in the two groups. If they are not comparable, any detected difference in outcome could be due to those differences and not to the treatment being tested. The treatment and control groups in the PREVENT study are not equivalent. The types of pain being experienced, for example, are not equally distributed. While 46% of participants in the treatment group have a pain that affects their muscles, the percentage jumps up to 70% in the control group. The use of pain medication is also radically different between the groups. Over-the-counter pain medication was used by over half of the participants in the treatment group and none in the control group, while prescription non-steroidal anti-inflammatory drugs were more than twice as likely to be used by the control group. These comparisons are almost always reported by researchers alongside a statistic called the p-value to show that the groups are not statistically different; their omission here is telling.
Another major absence is exactly how these people were recruited and assigned to each group. We know they were enrolled at three different places in the United States, but how they were chosen and why they were assigned to the treatment or the control group is never spelled out, except to mention that it wasn鈥檛 done by chance. Some participants dropped out of the trial, though we do not know how many or why. Did they quit the trial because the patch was not working? If so, the fact that their data was excluded from the final analysis is certain to bias how well the patch performs.
Finally, the subjectivity of pain rears its ugly head here. In the treatment group, at least one person reported that, before putting on the patch, their pain was a 10 out of 10, which the researchers describe as 鈥減ain as bad as you can imagine.鈥� I have trouble imagining how someone who is having the worst pain possible could fill out a research questionnaire. Their pain was probably not a 10 out of 10. This is a great example of how malleable a subjective pain scale like this can be. If you believe that this state-of-the-art patch, given to you by scientists in lab coats, must work, you might score your pain as less severe after the 30-day trial period, even if an objective measurement (if it were possible) would show no difference.
The fact that using the patch led to a significant decrease in the use of pain medication may look unexplainable if the patch doesn鈥檛 actually work. However, we do not know how the pain would have evolved without the patch. Patients in the treatment group are not said to have chronic pain; rather, they were 鈥渄iagnosed with a mild, moderate, or severe pain condition鈥� that was either arthritic, neurological, or muscular in nature. The last two are not necessarily chronic conditions. This particular pain could be acute, and thus resolve itself after a few days. And the control group being so small and so different from the treatment group, we cannot use it to clearly see the natural fluctuations of pain when the patch is not applied.
Suffice to say that this one trial, financed by the company that makes the patch, is not compelling, especially in light of the patch鈥檚 proposed mechanism of action, which sounds scientific but isn鈥檛. Reading the patent application for the device, I was surprised to find the suggestion that ! Combined with the claim that the Kailo patch doesn鈥檛 even have to be applied to the skin but works through clothing (even ), and I hope we can agree that this whole story just doesn鈥檛 ring true.
The Kailo patch exists because on the Indiegogo crowdfunding platform. Despair turns patients into customers, yes, but also into investors sometimes. We may not hear Peter Popoff screaming 鈥淗allelujah!鈥� when we apply the patch, but we should be highly skeptical nonetheless.
Take-home message:
- The Kailo patch is claimed to take away the pain you feel by restoring proper communication between the painful area of your body and your brain, and allowing the brain to heal the body
- Its proposed mechanism of action makes no sense given our understanding of the biology of pain
- The clinical trial that tested the patch was financed by its makers, compared two groups of participants who were not comparable, did not include a placebo, and makes no mention of how the participants were recruited and how many dropped out of the trial, thus potentially skewing the results significantly
