Patricia Sipes had tried just about everything to deal with her back pain, she says. Since childhood, Sipes, 71, often had "thrown out her back," and, in 2010, she injured it in a way that required surgery.
Caused by crushed disks, her injuries were treated with surgery, and then electrical massage therapy, acupuncture and medications for lower back pain after she developed more problems.
Sipes, who lives in Kempner near Fort Hood, tested Abbott's new Proclaim XR neurostimulation system this month to see whether it would work for her before it was implanted permanently on Thursday.
The Proclaim XR system was developed in Abbott's neuromodulation division in Austin and was approved by the FDA this month.
Sipes said her son noticed a big change in the expression in her face. She didn't reflect pain. "I was instantly moving a lot more fluidly and standing up straighter," she said.
That was only the test, which doctors perform to see whether the device will work on a patient before it is implanted in the lower back or by the neck. Two electrodes go into the space in the layers outside the spinal cord, similar to where a woman in labor gets an epidural. Electrodes are connected to the Proclaim XR device, which then is implanted into the body, similar to the way a pacemaker is implanted.
Neurostimulation systems are not new. What's new about the Proclaim XR is the way it delivers its electric pulses. Instead of constant stimulation, it provides a lower amount of stimulation and in a pulse pattern that is meant to mimic a brain's waves. The stimulation works to change the pain signals as they travel from the spinal cord to the brain.
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Abbott performed studies to figure out just how little stimulation patients would need and at what patterns to still get optimal pain relief. The result allows people using the Proclaim XR to not have to recharge the battery every day or two, which previous models required. Instead, the device could last up to 10 years before a patient needs a quick day surgery to replace the battery, according to Abbott.
"It brings the patient pain relief without the hassle of recharging," said Dr. Allen Burton, Abbott division vice president for chronic pain.
Previous systems required patients to place an external charger up to the stimulator and hold it there for an hour or so.
Burton said Abbott has been working to create a neruostimulator that didn't require recharging since the first rechargeable one was developed. At first, he said, they were thinking about seniors who might have trouble dealing with the recharging, but "then we starting thinking what about younger people, the super busy lady in her 20s or 30s who is chasing around three young kids. She doesn't have that time. What about the 45-year-old executive? Does she have time to recharge? Really, nobody can create an hour in their day. If they have to they will, but most people don't have time in their day to recharge."
Patients, he said, "are ecstatic about not having to recharge their battery. They were tethered to their charger. If it wasn't recharging, they were thinking about it."
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Delivering a lower dose of electrical pulses could have other benefits in addition to battery life. In theory, it could help prevent the problem of tolerance. That's when a body gets used to a therapy, and higher and higher doses are needed for the therapy to work, or it just stops being effective at all. While there hasn't been enough time and data to say for certain, "early data would suggest that is a possibility," Burton said.
Dr. Pankaj Mehta of Pain Specialists of Austin tested the Proclaim XR on patients and heard that they had "the first best week for so many years," he said. They slept well, and they could perform routines and activities without pain, he said.
He performed Sipes' surgery. In two weeks, she'll have her device's programming set to deliver the dose and pulse that will work best for her. She'll also be given an iPod that can control her device using Bluetooth so that she can change which type of dosing she needs at different times of the day.
Sipes said even her four-day test made a big impression. "It was a considerable relief," she said. "It really did stop a lot of pain that I wasn't aware of. When it goes away, it takes your breath away."
With the stimulator, she's looking forward to starting to walk more and not getting winded at the mailbox or having to lean on the cart at the grocery store.
She's excited about doing everyday things without having to sit down and rest. She'd also like to learn how to kayak. And, Sipes said, she'd like to be "sitting and watching the grandbaby without fighting my body all the time."