FDA Clears OTC Electromagnetic Pulse Therapy – Steve Duffy – Feb 2020
I haven’t tried this because my pain’s location is constantly changing, but for less than $30 on Amazon, it might be worth a try for localized pain.
The over-the-counter (OTC), drug-free medical device, ActiPatch®, has obtained a new 510(k) clearance from the Food and Drug Administration (FDA) for the adjunctive treatment of musculoskeletal pain.
The topical device is a wearable version of pulsed shortwave therapy that consists of low voltage (3V) digital/analog electronics that produce a therapeutic radiofrequency field.
The electromagnetic signal pulses to stimulate neuromodulation of the afferent nerves to reduce pain and inflammation.
Reviews on Amazon vary widely so, like other similar devices, it helps some people some of the time.
A 6-month prospective study evaluating the effectiveness of the ActiPatch in individuals with chronic pain (N=240) showed that the treatment provided a clinically meaningful reduction in pain in multiple anatomical locations following 7 days of treatment.
Findings from the study also showed that in 85% of treated patients, pain relief was sustained for 6 months.
Moreover, patients reported an improvement in functionality and a decrease in pain medication consumption.
And here’s a review by a pain patient:
A Review of ActiPatch, Advanced 24-Hour Pain Relief – National Pain Report – By Donna Gregory Burch – Feb 2018
I was given a 7-day trial device and a 720-hour device to use for this ActiPatch review. Although I was given these products for free, all opinions are my own and were not in any way influenced by ActiPatch USA. I did not receive any compensation from ActiPatch for this review and do not benefit financially from ActiPatch sales.
ActiPatch works by sending electromagnetic signal pulses 1,000 times a second “to stimulate neuromodulation of the afferent nerves to dampen the brain’s perception of pain,” reads ActiPatch’s website.
So, does the ActiPatch reduce pain? Well, for me it depended on the type of pain I was treating.
“Real-life patients” know from experience that even in the same patient, there can be different kinds and locations of pain.
Yet, all studies of pain lump together all chronic pain as a single symptom, from all locations, at all times, and from all causes, which makes no sense either scientifically or clinically.
The only purpose of such a blending of data is to find the results that the researchers need to get (due to funding). This is also what the CDC did by lumping together all overdoses from all opioids, prescribed or street drugs, which cleverly hid the fact that prescription opioids are NOT the problem.
I did not notice a difference in bodywide fibromyalgia/Lyme pain levels while using ActiPatch, but for localized pain, such as the pain in my lower back and knees, it makes a noticeable difference.
But what I think is most impressive about ActiPatch is how well it works given its low cost.
So, if you have localized pain, I would definitely recommend trying ActiPatch.
Author:Donna Gregory Burch was diagnosed with fibromyalgia in 2014 after several years of unexplained pain, fatigue and other symptoms. She was later diagnosed with chronic Lyme disease.
Donna covers news, treatments, research and practical tips for living better with fibromyalgia and Lyme on her blog, FedUpwithFatigue.com. You can also find her on Facebook and Twitter.
Donna is an award-winning journalist whose work has appeared online and in newspapers and magazines throughout Virginia, Delaware and Pennsylvania. She lives in Delaware with her husband and their many fur babies.
I will be skeptical. The FDA clearance does not necessarily mean it works, it merely means that it probably won’t electrocute anyone . They have cleared a lot of junk, and failed to step in to protect us from frauds and quacks. Our FDA is no longer functioning in their regulatory capacity, due to regulatory capture. These electromagnetic devices were sold by quacks a hundred years ago, but they have been rebranded for a new generation of desperate, vulnerable people, willing to try anything for pain relief.
It is highly irresponsible for a group, the National Pain Report, to publish these kinds of patient testimonials with no actual research of their own. There was a time, when these testimonials were illegal. Now with the internet, none of it is being tracked or regulated. Over the years these groups have been a source of misinformation and deceptive advertising. There was a time, when our government protected patients from deceptive advertising and frauds, now the only concern is profit, propaganda and deception.
“equivalent to legally marketed devices” There it is, the FDA has approved a lot of devices, and none of them are particularly effective, or more than a distraction. The Acti Patch has been on the market for 3 years, and if it worked so miraculously we certainly would have heard something. The approval for more body parts or musculo skeletal pain is just a gimmick, it allows the to market the “new” approval as if it is meaningful.
“The recent clearance was obtained for over-the-counter marketing of the medical device, extending the indications for the treatment of musculoskeletal pain to provide long-lasting chronic pain relief. In 2017, the ActiPatch® was FDA-approved for over-the-counter treatment of plantar fasciitis and knee osteoarthritis. This device remains the only PSWT (pulsed software therapy) device with over-the-counter approval for treating any form of musculoskeletal pain.”
Translation, PSWT means a proprietary name of their product, the only device to use this proprietary “pulsed software therapy.” The old tens units varied the intensity of the electrical activity, but they did not call it “pulsed software.” A meaningless marketing term. Those devices, and all of the one currently on the market do not cure chronic pain or offer much more than a distraction or soothing muscular movement.
The FDA approved the Quell device too, even though it could deliver random, distracting and painful electrical shocks, that had no effect on pain. They also hid the negative reports on thousands of medical devices, to protect industry profits. People died, from these defective medical implants, endured multiple surgeries, and sepsis, but they hid the reports long enough to protect the profits of these deceptive and corrupt corporations.
They have been using the so called opioid crisis to market all sorts of quackery and fraud, the fear of the horrors of opioid addiction is a good marketing ploy. None of these devices have been proven to stop even one case of illicit drug addiction. Not one piece of crap that they marketed using the so called opioid epidemic has resulted in any saved lives. They are thrown at people in pain, who are desperate and cannot afford basic healthcare.
I bet if I had enough money I could get FDA approval on a brick with a battery stuck to it, and it would be just as effective.”
BioElectronics is the leading provider of disposable, pain therapy, drug-free devices. Apart from ActiPatch® Therapy for back pain and other musculoskeletal treatment, its portfolio includes RecoveryRx®, used to treat chronic & post-operation wound and Allay® Menstrual Pain Therapy.
Here is another one of their products, they got to market it on TV, with all of the other nonsense these TV doctors promote for a price. I bet they did not compare it to a heating pad in their “clinical Tests.”
“Dr Masterson said that Allay sends an Electro-Chemical impulse to your uterus so that it decreases the cramping. You have to remember that cramping during your period is caused by your uterus cramping up.” There used to be laws against this kind of physician marketing too.
“Electro Chemical Pulse” another meaningless proprietary phrase meant to deceive. It is painful to read this clap trap!
The media amplifications and FDA “approvals” drive stock prices.https://microcapdaily.com/exciting-week-for-bioelectronics-corp-otcpink-biel/124825/
Good for swelling, bruising and scaring too! Why the heck not! Multi purpose! https://www.amazon.com/Actipatch-Menstrual-Swelling-Bruising-Recovery/dp/B0049VUUII/ref=cm_cr_arp_d_product_top?ie=UTF8 Men can use it too!
A down the rabbit hole tale of product placement, content generation, in content marketing, and how the FDA approval process, is a marketing tool!.
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You’re right, of course, and this may only help a handful of people some of the time with some of their pain. It seems to be totally unpredictable and not even likely to work. Yet some people do get some relief, it’s cheap, and desperate times call for desperate measures.
I cant speak to that review but I can tell you as a columnist for Pain news Network I was asked to evaluate 1 product. At no time was I expected to submit a review for the site. (I, and believe one or 2 others who tried it found it to be no good and that was the end of it) I find it disturbing that a site that purports to be independent would use such a review that seems to be simply promotional for the product
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Well, if it works even for just a few people, it might be worth a try in the continued crackdown and forced tapering of opioids. We’re grasping at straws her…
I didn’t see the NPR article as “promotion”, but rather a personal experience. That doesn’t mean anyone else’s experience will be the same, but the low price and availability without dealing with an expensive doctor’s visit is a big plus to me.
Now that doctors are all owned by finance companies, I find them exceptionally useless. They are forced to follow rules that maximize income and avoid any potential lawsuits (for their overlords, that is). These constraints deviate from what used to be the “practice of medicine” and has made doctors just another tool of income extraction from patients.
I‘m just reading that “low-intensity ultrasound waves directed at a particular region of the brain’s prefrontal cortex in healthy subjects can elevate mood, and decrease connectivity in a brain network that has been shown to be hyperactive in psychiatric disorders.” – this twitchy instability definitely sounds like me. I know this device isn’t the same, but perhaps I could use it around my head? After all, that’s where pain signals, both physical and psychiatric, are processed to give me such grief.
If you see a therapist psychiatrist or pain doc I would ask them. It sounds like it probably wont cause harm but always asking someone who would have a more thoughtful thought about it
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At least therapists are still allowed to “practice therapy” and aren’t constrained to provide only the treatments that are endorsed by profiteers, as medical doctors are now.