If you suffer from knee pain, you may have tried to “grin and bear it”—and when that didn’t work, you may have resorted to the typical medical options, cortisone shots and heavy-duty pain meds. Both have negative side effects. Now a newly FDA-cleared procedure uses cold to stop knee pain almost immediately…and keep it away for months. But it’s not for everyone.

The new procedure is called iovera. We asked Halland Chen, MD, an expert in knee pain, sports injuries and back pain who uses iovera in his New York City practice, to give us the lowdown on this new approach to treating knee pain.

HOW IOVERA WORKS

The iovera system is based on the science of cryotherapy—a therapy introduced in the 1950s that uses localized freezing temperatures to temporarily deaden a nerve, thereby relieving pain. After numbing the area with a topical anesthetic injection (lidocaine), a doctor inserts a quarter-inch-long three-pointed probe cooled well below 0°F by liquid nitrous oxide (yes, laughing gas) into one or both knees. The cold deadens specific peripheral nerves associated with knee pain without damaging other nerves or tissue.

The nerve deadening isn’t permanent. The peripheral nerves are damaged, but they recover. That temporary stage of nonfunctioning—putting the nerve in cold storage—stops pain signals from being transmitted from the nerve to the brain. For the next three to six months, until the nerves regenerate, patients experience relief from pain, enabling them to exercise, engage in physical therapy or make whatever lifestyle changes are necessary to help address the cause of the problem.

And feel relief.

The procedure is considered minimally invasive and typically is performed in a doctor’s office. It takes about 30 minutes. And relief is quick. Says Dr. Halland, “I have had patients come in using a cane, and after the treatment, they can walk unaided and pain-free.”

LIMITED RESEARCH AND A PRICEY COVER CHARGE

While promising, it’s important to realize that although cryotherapy has been around a long time, this is a new, patented procedure with no long-term data on safety or effectiveness. We know don’t the long-term effect on cartilage or ligaments, for example.

It’s also important to realize that this is an FDA-cleared product…which is very different from FDA-approved. Unless medical devices are potentially life-threatening or life-sustaining (such as a defibrillator), they don’t go through the same kind of rigorous safety and efficacy test as do pharmaceutical drugs. In this case, this product was FDA “cleared,” which means it’s similar to another product on the market.

Currently, there is only one completed study on the effectiveness of iovera…and it was conducted by the manufacturer. The six-month study involved 33 subjects. Pain dropped in 88% of the subjects by day seven…70% reported pain relief was still there after two months…and 45% reported pain relief lasting for three months. What about six months? The study hasn’t been published publicly, and the company, Myoscience, hasn’t put that info on its website. Two other clinical trials are underway—one to evaluate iovera’s effectiveness and safety for temporary reduction of pain associated with knee osteoarthritis and a second for treating pain associated with total knee replacement.

While iovera can successfully treat knee pain, Dr. Halland emphasized that it doesn’t correct the underlying cause. “If you have knee pain because you have a torn meniscus or you have arthritis, it won’t fix that. But by relieving the pain, patients can do what is needed to improve their overall condition.” Dr. Halland often combines iovera with a viscosupplement injection, which serves to lubricate and protect the knee joint surface. He recommends physical therapy to his patients so that they can learn to exercise safely and encourages them to do a home exercise program that includes stretching and quadriceps/hamstring exercises.

A few more caveats…

• Iovera is less effective at treating pain behind the knee than pain in or above the knee because the peripheral nerves treated by iovera don’t reach those areas.

• Similarly, iovera isn’t recommended when pain is caused by a complex medical condition such as fibromyalgia or an injury such as an anterior cruciate ligament (ACL) or posterior cruciate ligament (PCL) tear.

• Iovera is not to be used at all in people with certain blood disorders that are affected by cold—cryoglobulinemia (blood proteins clump), cold hemoglobinuria (a red blood cell disorder), cold urticaria (skin reactions to cold) and Raynaud’s disease (which affects peripheral circulation)—or anyone with an open or infected wound near the knee.

• Side effects are typically transient, with some patients reporting local pain, crusting, pigmentation changes, bruising and tingling, according to the manufacturer.

• It can cause pain—to your wallet. With an estimated cost of $1,000 per treatment, and two to three treatments needed per year, this pain relief definitely comes at a substantial cost, and it is only beginning to be covered by some insurance plans.

• Currently iovera is so new that it’s available in only five states—California, Illinois, Louisiana, New York and North Carolina.

If you decide to try this new approach to chilling out knee pain, remember that it affects only the pain, not the underlying condition. If you treat pain relief as a free gift and either keep to your sedentary ways or, conversely, start playing sports that might hurt your knee, you’re not doing yourself any good. But we know that regular low-impact exercise, as well as strength training, is key to slowing the progress of osteoarthritis. If this new treatment helps you get back to daily walks and into the gym, it might be just the thing.

For more information or to find a medical practice using iovera, visit the iovera website.