FTC Takes Dim View of Light Therapy Device

By Pat Anson, PNN Editor

Low level light therapy (LLLT) – also known as “laser therapy” – has been touted for years as a treatment for arthritis, neck and back pain, fibromyalgia, neuropathy and even spinal cord injuries.

But in the first case of its kind, the Federal Trade Commission is going to court to get the makers of a light therapy device called the Willow Curve to stop making deceptive claims that it can treat chronic pain.

“When LLLT sellers say their devices will relieve pain, they’d better have the scientific proof to back it up,” Andrew Smith, Director of the FTC’s Bureau of Consumer Protection, said in a statement. “People looking for drug-free pain relief deserve truthful information about these products.”

In a complaint filed in federal court against the inventors and marketers of the Willow Curve, the FTC alleges that Dr. Ronald Shapiro and David Sutton “personally made deceptive claims about the health benefits” of the device and falsely claimed it was approved by the Food and Drug Administration to treat chronic pain, severe pain and inflammation.

Willow Curve is a curved plastic device that delivers low-level light and mild heat to painful areas. It’s been sold online and through retailers and healthcare professionals since 2014, most recently at a price of $799.

In a 2016 commercial, television personality Chuck Woolery said the Willow Curve offers “drug free pain relief for the digital age” and personally promised that “the Curve could change your life.”

Other advertisements tout Willow Curve as “clinically proven” and the “world’s first digital biosensory, biotherapeutic laser smart device” — even though there is no scientific evidence to support those claims, according to the FTC complaint.

The FTC also alleges that Shapiro and Sutton deceptively claimed Willow Curve comes with a “risk free money back” guarantee. In reality, consumers who returned the device had to pay shipping and handling costs, and often did not receive a refund at all or had to wait more than a year to get their money back.

The settlement imposes a $22 million judgment against the defendants, which will be partially suspended if Shapiro and Sutton each pay $200,000. It also asks the judge to issue a permanent injunction to prevent future false advertising of the Willow Curve. The complaint was filed in the U.S. District Court for the Eastern District of Michigan.

Treating Chronic Pain With Lasers

By Madora Pennington, PNN Columnist

Months after surgery for my badly broken foot, the last scab finally fell off, revealing to my horror that the surgical incision had not closed. I have Ehlers-Danlos Syndrome (EDS), a genetic condition that prevents my body from building proper collagen. Poor wound healing is a common complication for people like me. 

A search for a treatment that would help led me to Dr. Harold Kraft, a Southern California anesthesiologist who has built an entire practice around using high-powered lasers. Kraft’s main focus is pain --- from sciatica and back pain to neuropathy, neuralgia and myalgia, as well as post-surgical pain and soft tissue injuries. 

Another thing lasers do is facilitate wound healing. After a few appointments, my wound closed but appeared fragile and Frankenstein-looking. With more treatments, it rapidly filled in, coming to look smooth, strong and, surprisingly, pretty.

I was eager to try laser for my Ehlers-Danlos aches as well. My strange body seems to sustain soft-tissue injuries from the ordinary tasks of life, draining my energy and taxing my nervous system. From the laser treatments, I experienced relief I had never before felt.

Kraft has learned a lot from administering over 20,000 treatments on patients. He noticed Ehlers-Danlos patients got exceptional pain relief from the laser treatments, and came to find that nearly all are super-responders.

“About 90% of EDS patients respond to laser treatment, and get faster and more profound pain relief than typical patients,” Kraft notes.

Light Amplification

The word “laser" is an acronym for Light Amplification by the Stimulated Emission of Radiation. No longer limited to science fiction movies, lasers are now a part of everyday life. You’ve probably seen lasers used as pointers during presentations, as bar code scanners, and in DVD players. In medicine, lasers can be used for precision cutting, such as in LASIK vision surgery or for excising a tumor. For cosmetic purposes, a laser can improve skin imperfections or whiten teeth.

Light particles, or photons, from the laser pass through the skin and stimulate the cells’ mitochondria to release anti-inflammatory modulators, nerve and vascular growth factor. This causes healing and repair.

Kraft came to having a pain practice late in life. He had retired from a long career of performing anesthesia during surgery and left medicine entirely for the business world, developing software for data aggregation. All that changed when his wife took their long-suffering pug for a new treatment.

Harley, a most beloved dog, had trouble walking. He had not benefited from joint supporting supplements like glucosamine and chondroitin, nor acupuncture and doggie physical therapy. But after four treatments of high dose laser from a veterinarian, Harley could walk again. The Kraft’s were elated and also intrigued.

Kraft convinced a family friend who had back pain to see that same veterinarian for lasering, even though she is a human. Like Harley, she found pain relief.

Seeing the promise of what this could offer, Kraft began training in laser techniques and got laser machines of his own. He went back to practicing medicine, treating pain exclusively with lasers. Kraft uses Class IV lasers, which are the most powerful available. He employs them at high doses, in order to do the most good for patients. Great care must be taken in this endeavor.

“The more power you use, the more care you need to operate and the more likely that misapplication can cause harm,” Kraft says. “There is no discomfort during treatment, although the patient may feel the heat from the laser. It is powerful, non-invasive, and the results can be permanent or long-lasting.”

Kraft says about 7 out of 10 patients get significant improvement, including chronic pain sufferers who failed at other treatments. Genetics seem to play a factor in how well a patient responds. Some are just faster than others. A small percentage respond immediately. Most experience benefit between 4 and 10 treatments, and only about 30% do not respond after 14 or so treatments.

What does the science say about laser therapy? While there isn’t an abundance of research on the healing power of Class IV laser, some exist and are worth noting:

Chronic and acute pain are notoriously difficult to treat, especially in an era when fewer doctors are willing to treat pain or prescribe opioid medication. Pain patients have fewer options.

Dr. Kraft imagines a world where patients will have easy access to laser therapy at their primary care doctor or physical therapist. In addition to running his busy practice, Dr. Kraft has invented an improved laser, one that would optimize treatment regimen. He hopes to have it to market in two years.

Madora Pennington writes about Ehlers-Danlos and life after disability at LessFlexible.com. Her work has also been featured in the Los Angeles Times.

Lasers Work for Fibromyalgia, But Why So Pricey?

By Ryan Baker, Guest Columnist

I’ve had severe fibromyalgia for 14 years, and I’ve been disabled as long. Without a doubt, the pain is certainly a central issue, along with the severe fatigue, flare ups, and crashes.

It’s an absolutely miserable disease that’s intrusive and destructive. I broke commitments that really shouldn’t be broken, which put a strain on personal relationships. The pain is a level of suffering that can easily push one to insanity or worse.

I found laser therapy last October at my chiropractor’s office, where they have a $25,000 K-Laser. While it worked great, I could not get enough coverage all over my body as often as I needed, and it was just too expensive for office visits.

I was getting good results, so I dove into trying to find a laser I could use at home, and settled on a very effective unit for $2,500. Pricey, but worth the convenience of having one I could use whenever I wanted.

Since receiving the TQ Solo laser in late January, I have not taken any prescription pain pills. My hydrocodone, methocarbamol, and Klonopin, which I had whittled down long before the laser to “emergency use only” (once every 3-7 days), have gone untouched since I’ve had the laser.

I have taken 2 ibuprofens for a dehydration headache, but no other OTC meds, aside from vitamins. I take a sleep aide and blood pressure medication, that’s it.  

TQ SOLO LASER

It still astonishes me how well laser therapy works. I still suffer from fibro fog, low energy, and all of the other problems associated with fibromyalgia, but my pain levels have dropped from a constant 7-9 out of 10, to a much more tolerable 2-4. I use the laser between 20 minutes to an hour or more a day, and rather than become resistant, my body seems to respond better after getting used to treatment.

Some areas are completely free of pain at times, which hasn’t happened in 14 years, but if I stop treatment the pain returns. It’s not a cure, my fibro is still terribly limiting, but it’s an amazing treatment for the pain. The decrease in my personal suffering has been outstanding.

The laser is like an alarm clock for under active mitochondria, only stimulating the cells in need. Properly functioning tissue (not in pain) have little to no response, while damaged or inflamed tissue “wake up” and begin healing. Some areas need daily treatment, like my calves and back, while other areas can go days between treatments.

If you’re a fan of science fiction, this is the coolest thing since the smartphone made Captain Kirk’s communicator look silly.

I find the 5 hertz setting, the deepest setting, to be the most beneficial. It’s like a massage, but deeper, and there’s no pain from working tender tissue. In fact, there is very little sensation during treatment. If I can feel the treatment at all, it’s usually a mild tingle or twitch, which I consider a signal to treat more intensely.

The laser does not hurt or burn. It’s very comfortable and soothing, and treating before bed is fantastic for sleep. I don’t wake up with that stiff, poisonous feeling ache anymore.  

I began researching all sorts of red light therapy. I’ve tried several, along with some LED only therapies. I even tried a heat lamp. While the heat lamp and LED therapies felt okay, they were no match for the laser.

While searching for other light therapy devices, I found the Handy Cure. It has a striking resemblance to the TQ Solo I had purchased, but it was selling for under $600. Same frequency settings, same power, same everything. Only the handle was different, as far as I could tell.

I looked it up, and it was made by the same company that makes the TQ Solo. But why so much cheaper? Was it a knock off? Was it less potent, or somehow lower quality? I put an order in.

After using the Handy Cure side by side for weeks with the TQ Solo laser, I can’t tell any difference. It’s just as effective. I’d overpaid by $2,000. I’m not wealthy, and I assume most fibro patients aren’t either, so that hurt.

I started looking into other lasers and found the Game Day laser. It looks exactly like the Handy Cure, no doubt about it, only the labels were different. Instead of variable, 50 hertz, and 5 hertz, the menu is a simple 1, 2, and 3. It appears to me that the Game Day is simply a rebadged Handy Cure.

handy cure laser (left) and TQ solo laser(right)

You’d think the Game Day would be priced more like the Handy Cure, but it’s listed for $2,995! My jaw dropped when I saw that, but the picture became crystal clear. All of these lasers had the same manufacturer and, except for subtle differences, appear to be essentially the same products.

But one sells for under $600 and the other is marked up to nearly $3,000. Why?

I’m not against the profit motive, but I am when people are suffering and treatment is unnecessarily kept out of reach.   

One month later, I have become a distributor for the Handy Cure, making YouTube videos to bring laser therapy to the attention of fellow fibromyalgia patients. It’s been a big adjustment, but a meaningful one. I have no idea what I’m doing, I just know lasers work, and they take some of the “crazy” out of fibromyalgia.

Fibromyalgia pain is real and physical, not some form of hypochondria or mental illness. If it was, the laser would have no physical effect. But it works reliably for my pain, even when I’m particularly depressed.  

I feel vindicated, because something finally works for the pain when powerful opiates barely made a dent. It’s not in my head. 

(Editor's note: Since this article was first published, Pain News Network has been contacted by Max Kanarsky, President and CEO of Multi Radiance Medical, the maker of the Handy Cure laser. Mr. Kanarsky maintains that the "Handy Cure" featured in this article is a counterfeit reproduction of his product, is not FDA cleared, and "might present a hazard to users.")

Ryan Baker lives near Sacramento, California. You can learn more about laser therapy by visiting his website, Chronic Pain Laser.

Pain News Network invites other readers to share their stories with us.  Send them to:  editor@PainNewsNetwork.org

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