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.

Light Therapy Used to Treat Neuropathic Pain

By Pat Anson, Editor

For someone with peripheral neuropathy, even the slightest touch can cause burning, stinging or shooting pain, usually in the hands or feet.

The pain is caused when the peripheral nervous system is damaged by diabetes, shingles, chemotherapy or some other medical condition. About 8% of adults worldwide suffer from some form of neuropathy. Medications prescribed to dull the pain – such as opioids, anti-depressants or gabapentin (Neurontin) -- often prove to be ineffective, don’t last long or have unwanted side effects.

Scientists in Italy have now discovered an experimental way to treat neuropathy that provides pain relief for weeks at a time without the use of medication. In experiments on laboratory mice, researchers at the European Molecular Biology Laboratory (EMBL) in Rome identified a specific set of nerve cells in mouse skin that play a significant role in neuropathic pain.

NATURE COMMUNICATIONs

When injected with a light-sensitive chemical and then exposed to infrared light, the nerve cells pull away from the skin’s surface and stop sending pain signals. The pain-relieving effects of the light therapy appear to last for weeks.

The accompanying image shows the skin of a mouse, with the nerve cells that are responsible for sensitivity to touch highlighted in green. The neurons are primarily located around hair follicles.

The EMBL's research, first reported in the journal Nature Communications, is still in its early stages. But scientists say human skin tissue is similar to that of mice, indicating that light therapy might be effective in managing neuropathic pain in humans.

"In the end, our aim is to solve the problem of pain in both humans and animals," says Paul Heppenstall, PhD, EMBL group leader. "Of course, a lot of work needs to be done before we can do a similar study in people with neuropathic pain. That's why we're now actively looking for partners and are open for new collaborations to develop this method further, with the hope of one day using it in the clinic."

Heppenstall says light therapy works on the treated nerve cells the same way spicy food or capsaicin patches can cause nerve fibers to retract.  

"It's like eating a strong curry, which burns the nerve endings in your mouth and desensitizes them for some time," says Heppenstall. "The nice thing about our technique is that we can specifically target the small subgroup of neurons causing neuropathic pain."

There are many different types of nerve cells in skin, which respond to different sensations like vibration, cold, heat or normal pain. Researchers say those cells are not affected by the light treatment. The skin is only desensitized to a gentle touch, breeze, or tickling.

Previous attempts to develop drugs to treat neuropathic pain have mostly focused on targeting single molecules.

"We think however, that there's not one single molecule responsible, there are many," Heppenstall explains. "You might be able to succeed in blocking one or a couple, but others would take over the same function eventually. With our new illumination method, we avoid this problem altogether."

The neuropathic pain in mice was assessed with a simple touch. The mice would normally quickly withdraw their paw when it was gently touched, but after light therapy they exhibited normal reflexive response to touch. The effect of the therapy lasted for a few weeks, until the nerve endings grew back and the gentle touch caused pain again.