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A more direct way to treat pain is being developed in Cleveland
A new electric nerve stimulation device for drug free joint pain relief is nearing FDA approval
by WKSU's KEVIN NIEDERMIER


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Kevin Niedermier
 
An electronic stimulator for pain relief being developed by SPR Therapeutics in Cleveland. Unlike current electronic pain relievers, a thin wire on this device can be inserted directly into a moving joint.
Courtesy of Kevin Niedermier

A biomedical company in Cleveland is developing a device that helps ease chronic pain without drugs. SPR Therapeutics is working on an electrical stimulation device that targets specific nerves…a different approach than the devices developed in the 1960s. As WKSU’s Kevin Niedermier reports, SPR Therapeutics is about two years away from FDA approval.

 

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Stroke victim Tom Galiea of Concord was one of the first patients to test SPR's device. His pain stopped after 4 weeks of treatment.
Maria Bennett is president and CEO of SPR Therapeutics.  She hope clinical trials of their SmartPatch system will receive FDA approval in 2016.
SPR director of mechanical engineering, Jonathon Sakai, helped develop the SmartPatch.
Dr. Salim Hayek heads the pain management department at University Hospitals.

An estimated 100million people experience chronic pain, a condition that can lead to depression, loss of sleep and productivity. For decades, electrical stimulation has been used to ease pain from spinal conditions. That method uses electrodes placed on the skin. SPR’s device is different because a wire attached to a small device can be inserted directly into a nerve in a moving joint. Clinical testing began in 2009 on shoulder pain associated with stroke. Tom Galiea suffered a serious stroke 13 years ago.  Doctors told him he would never walk, talk or use his left side again.  Galiea has proven them wrong, and says the key to his recovery was easing his shoulder pain. In 2009, he became one of the first patients to test SPR’s new technology.

One of the first clinical trial patients has remained pain-free

“Basically I was on pain pills all the time, it was so bad I couldn’t sleep. I was using compress, heat wraps and shoulders straps, I had to have my arm up.  I did the 4 week program where it stimulated that muscle.  And I know, probably after the first week it was amazing how I had that big of a transformation.”

Galiea, now 62, has not had pain in that shoulder since the trial. He’s gone on to walk in a two-mile charity event, and he councils other stroke victims on getting better. Maria Bennett is president of SPR Therapeutics. She says not all of the trial patients have had such good results, but many have. Bennett says the key is replacing the old method of electrodes on the skin with a hair-sized wire that can be implanted during a quick doctor’s office visit.

The new device works inside the body, unlike older technology

“By putting a portion of the wire inside the body it can target the area of pain, but it also bypasses anything the patient would feel on the skin. “

Bennett says the old units can be effective, but sometimes turning them up high enough isn’t possible because of the pain they cause on the skin’s  surface. With the SPR system, the patient wears a stimulator unit about one-third the size of a deck of cards near the site of the pain. The unit is held on the body with a pad that contains a battery that powers the device for a prescribed amount of time, like a time-released pill.                                            SPR Therapeutics mechanical engineer Jonathon Sakai says providing a precise amount of stimulation is crucial.

Keep patients from overusing the stimulation is important

“When we’re stimulating nerve and tissue directly, the amount of error you can have with this electrical signal is extremely close, it’s set by international standards. The device can be programed by a clinician and they specify a range of theraphy so the patient cannot over do it.”

Dr. Salim Hayek is chief of pain management at University Hospitals in Cleveland.  He says anything that can replace drug therapy is good, and the new technology is a promising advancement over the older devices.

“The idea was that if you stimulate a sensory nerve a lot, then it’ll distract the pain signal and take away pain. This newer application is stimulating a nerve that goes to a muscle and this is a new venue and application of stimulation. They’ve shown, Dr. Chea, a collogue, that it can control the pain in a good proportion of their patients.”

SPR hope to apply the new device to several types of pain

SPR Therapeutics stimulator is expected to be approved for shoulder pain use in the U.S. in 2015 or 2016. It is already approved for that use in Australia and Europe. The company is also conducting clinical trials to use the device for pain in other joints, and for pain from amputations. A U.S. military grant is funding the amputation trials at the Walter Reed Veterans Hospital.


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