FDA Approves a Laser Therapy Device for Fibromyalgia Pain Relief

laser therapy

There’s a new product on the market to treat pain associated with fibromyalgia. It’s neither a drug nor a wellness regimen—it’s a pulsing beam of light.

FibroLux, a laser-based therapy developed by Multi Radiance Medical, became the first so-called “photoceutical” device approved by the Food and Drug Administration (FDA) to help fibromyalgia patients manage pain.

Fibromyalgia is a chronic condition that causes muscle and joint pain all over the body. Fibromyalgia patients are often highly sensitive to pain that wouldn’t typically bother most people, and they may experience extreme fatigue and memory problems. It affects about 2% of people in the United States..

Scientists don’t yet know a cause or cure for the condition. Existing medications for fibromyalgia can be relatively ineffective and come with serious side effects.

“This is a group [of patients] that has never had options. The advice has been, ‘go exercise, go take this drug, or do nothing. Those are your options,’” Douglas Johnson, LAT, ATC, senior vice president of clinical and scientific affairs at Multi Radiance Medical, told Verywell.

Johnson said the new FDA approval adds another treatment option to provide quick pain relief with virtually no side effects.

FibroLux isn’t a cure for fibromyalgia. The company has only tested its effectiveness over the course of three weeks, meaning it’s not yet clear how lasting the relief from pain is. But it could be a useful additional tool for patients who are already using other treatments.

The device is safe for at-home use or as part of a physical therapy visit. It only takes a couple of minutes to treat each pain point, so a therapy session will likely take between four and 36 minutes.

How FibroLux Works

The company conducted two clinical trials, with the largest one involving 90 women ages 30 to 55 years. Half of the patients in that trial were given the therapy three times a week, with two days between each treatment, for a total of nine treatments.

Fibromyalgia patients may have up to 18 tender points. The laser therapy targets those points. In the clinical trial, the treatment reduced the number of pain points by 20% or more in 87% of patients. The approach also cut patients’ overall pain ratings by more than half.

A fifth of the study participants experienced mild side effects, nearly on par with the placebo group. The most common side effect was pain and itching on the skin..

The device works by blasting flashes of light into the skin at a speed of one billionth of a second. After an injury, nitric oxide can build up in cells to help reduce the pain response. But sometimes it clogs the cells and prevents them from creating energy. The so-called “super pulsed laser multi-wavelength emitter” can penetrate the skin and knock nitric oxide out of the cells.

Doing so quickens the healing process, promotes tissue regeneration, and relieves pain and inflammation.

Multi Radiance Medical has used this technology in other devices aimed at treating muscle pain. It’s been shown to help reduce pain in people with knee osteoarthritis, lumbar pain, and chronic neck and shoulder pain.

“We had to go to the FDA and convince them that we’re doing something different here. We’re not just masking their pain, we’re impacting the neurological function in a different way,” Johnson said..

Pair It With Exercise

Providers often recommend fibromyalgia patients exercise as often as they can. Even five minutes of movement three times a week can be helpful, said Scott Zashin, MD, a board-certified internist and rheumatologist in Dallas. Aerobic exercise increases endorphins, improves sleep, and improves well-being.

“We encourage all patients with fibromyalgia to do aerobic exercise and a lot of patients are unable to do it because they’re either they’re in a lot of pain or they’re tired,” Zashin, who is not involved with FibroLux, told Verywell.

But fibromyalgia patients may associate exercise with stiffness and muscle pain. Improving muscle recovery could encourage patients to exercise more frequently..

Multi Radiance Medical has developed other laser therapy products to reduce muscle pain and fatigue from exercise.

“Normally when you exercise, you may develop that ‘no pain no gain’ attitude. We are saying, well, we can do the gain with no pain,” Johnson said.

Multi Radiance Medical tested the device in a group of people who received the light treatment, others who paired the therapy with an exercise regimen, and a placebo group. They found that pairing light therapy with exercise made the results even better.

“It was kind of like a double whammy, if you will. Not only can we help control their pain, but we were also able to help them exercise better.”

How Laser Therapy Fits With Other Treatments

The FDA has approved three drugs to treat fibromyalgia syndrome: duloxetine (Cymbalta),milnacipran (Savella), and pregabalin (Lyrica).

Patients tend to struggle to adhere to these medications due to poor efficacy, uncomfortable or harmful side effects, or both.2

Zashin said he’s waiting to see how pricey FibroLux is and more data on the long-term effects of the therapy. In the meantime, however, he would prescribe the device if a patient felt compelled to try it.

Unlike pharmacological and other systemic treatments, which treat pain all over the body, FibroLux targets certain pain points. It could supplement a regimen of medication, exercise, massage, and other therapies..

Despite emitting high-energy blasts of light, Johnson said there is no heat or pain associated with using the device. In fact, it’s safe enough on the eyes and skin that a patient could use it at home on their own.

Johnson estimates the product will be priced at $2,000 to $3,000 and said that Multi Radiance Medical is working to get insurance coverage. Patients could also receive the treatment as part of a physical therapy regimen.

The laser therapy would serve as a supplement to pharmacologic drugs or as a replacement for patients who don’t tolerate those medications well.

“People who suffer from fibromyalgia need to have an army of options, and that’s what’s been lacking in the care,” Johnson said..

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