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New Hope for Phantom Limb Pain

A new peripheral nerve stimulation system is providing long-lasting pain relief for patients with phantom limb pain.

On May 4, 2014, David Nipple was riding his motorcycle near his former home in Franklin, Tennessee, when the intoxicated driver of a Chevrolet Tahoe crossed into his lane and hit him. Nipple's left leg was severed above his knee at the scene. He was taken to a Nashville hospital for acute care, although medical workers didn't think he'd make it. Fortunately, he survived; however, Nipple's new life was marked by excruciating phantom limb pain.

"It felt like my leg was reliving the accident," he says. "I felt tons of pressure pushing my left foot to the right, and the femur being pushed to the left, just as it happened during the accident."

Nipple says at that time his pain level was at a 10. It was so bad that he sometimes couldn't sleep-for days. He found most pain medications ineffective and was reluctant to take them anyway. He assumed he would have to live with the pain.

Then one day, nearly a year after his accident, Nipple came across a Facebook post about a clinical trial for those suffering from phantom limb pain. Curious, he filled out the application and was accepted into the trial. Thankfully, he went on to experience significant pain relief as a result.

A New Method of Nerve Stimulation

The clinical trial Nipple participated in was for SPRINT PNS, a peripheral nerve stimulation system. Unlike spinal cord stimulators, which stimulate centrally at the spine, the SPRINT system focuses on peripheral nerves, where it is able to have a greater impact on nearby sources of pain.

"We're doing something a little different in targeting the peripheral nerves in the area causing the pain," says Maria Bennett, president, CEO and founder of SPRINT's creator, SPR Therapeutics. "The spinal cord stimulators work more centrally, which often means patients with phantom limb pain are going to receive less relief."

Until the introduction of peripheral nerve stimulators, the only option for locally applying nerve stimulation was through the adaptation of spinal cord stimulator leads, says Christopher Gilmore, MD, one of the physicians involved in the SPRINT clinical trial. This method posed problems, however.

"Ergonomically, the spinal cord stimulator leads aren't designed to be used there, so we received suboptimal results," he says. "But now, with a device like SPRINT, we have a much more ergonomic and specific therapy for peripheral stimulation, and I think that dedication to the periphery is what is allowing us to see long-term results with these devices."

Bennett explains that SPRINT does not require a permanent implant, but rather is applied through a thread-like wire that is pre-loaded into a needle. The needle introducer goes through the skin and deploys the wire in proximity to the target nerve that's causing the pain, and the needle is then removed. A portion of the wire stays inside the body, and a portion of it exits the body and is connected to an external stimulator that's worn on the skin. After that, patients go home with the system. The doctor can program three different modes for them to use within their therapeutic range-low, medium or high.

Patients with phantom limb pain who have participated in the trial have seen significant improvements in their pain. Nipple, who was treated by Dr. Gilmore during the trial, says his pain went from a 10 to a 2.

"In a case just recently, one of our team members saw a woman who had had amputation pain for decades, and it was the first time in decades she experienced relief from pain," says Bennett.

According to Bennett, this system can address both phantom limb pain and residual limb pain. "We have done a significant amount of research in lower extremity amputees, folks who have had amputation below the knee," she says. "Traditional systems have had some success in residual limb pain, but it's been very difficult to have any sort of relief in phantom limb pain. SPRINT is a device that treats both."

While SPRINT's main advantage is targeted pain relief, it does have other benefits. Unlike spinal cord stimulators, which require permanent implantation, this system is inserted subcutaneously and is removed after approximately 60 days of use.

"This therapy doesn't require anything to be permanently implanted," says Dr. Gilmore. "That means patients don't have to fully commit to a permanently implanted device."

Despite the short-term use of the device, the SPRINT system has shown long-lasting outcomes. "The results of the study demonstrate that the pain relief far outlasts the duration of the temporary implant," says Dr. Gilmore. "The patients not only realized significant pain relief when the system was on, but there was also a carryover of sustained pain relief that occurred after the device was removed."

Dr. Gilmore points out that the patients he treated during the trial ranged from those who had undergone previous interventions that had failed to those who had only been exposed to conventional medical management. He says he has seen the long-term pain relief in patients last for many months-and even years, in some cases.

"Patients report significant pain relief, but pain can be subjective," says Bennett. "So the most compelling data has been related to how the device has impacted patients' quality of life."

Bennett says it has also been important to evaluate how the system affects patients' abilities to wear prosthetics without any pain. "The SPRINT System is designed to be used early after amputation, in an attempt to help patients be active earlier and adapt faster to prosthetics," she says.

The Veterans Administration in Richmond, Virginia, initiated a study on the SPRINT device in acute amputee pain immediately following amputation and has started using the device for those undergoing amputations.

"Earlier intervention is always better-especially earlier in the pain cycle," says Bennett. "If you can use it earlier, there's a greater likelihood of having that carryover effect."

Nipple received treatment with the SPRINT device in 2015, before he received his prosthetic. And now, about two years following his treatment, he's still experiencing reduced pain. "My pain level has remained where it was when it dropped during the treatment," he says. "I've been impressed. I've had a couple of experiences where the pain came back, but it didn't last. I've got no complaints."

Patients can undergo a second treatment period with the device if their pain returns.

The large majority of patients in the studies have had favorable responses, but due to each patient's individual pathology and anatomy, it can be difficult to predict a patient's outcome. Both Bennett and Dr. Gilmore point out that the temporary nature of the device makes it less risky for a patient to try. Because it's a short-term treatment-and less expensive and invasive than a spinal cord stimulator-it doesn't require as costly or permanent a commitment.

SPR Therapeutics received FDA approval for the device last year and is now engaged in a limited launch of the device.

In addition to phantom limb pain, SPRINT has also been used to manage lower back pain, post-stroke shoulder pain, peripheral neuropathic pain and pain following knee-replacement surgery.

"There are patients who didn't think they could be helped who are now getting back to normal lives," says Bennett.

"With the pain that hit me before the therapy, I didn't want to do anything, " Nipple says. "Sometimes I would just sit there crying. But now that's changed. I can get out. I sleep better. I can enjoy my life more since I'm not in agony over phantom pain. I ride a Spider now (a three-wheeled motorcycle)-I have 23,000 miles on it and rode it all the way to Wisconsin. If I were still having the phantom pain issues, there's no way I could've done that. I'm able to live my life again."

If you suffer from Phantom Limb Pain and want to learn more about treatment options, contact us at 336-765-6181.

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Dr. David Mount

Dr. David Mount would rather listen than talk. It's not that he doesn't have plenty to say. But on a patient's first visit, he wants to hear what led the patient to his office. The neuropsychologist has a keen interest in the mind/body connection and a focus on how pain affects the brain. ( "Pain impacts self-esteem and personal well-being," he says. "It can cause internalized agony.") Patients come to him with a variety of physical conditions-diabetic neuropathy, rheumatoid arthritis, pain associated with an injury or surgery-and a variety of cognitive impairments that have resulted from a physical condition. Patients from all over the country (and the world) seek him out through his Mind Body Institute Beyond, located in Winston-Salem, North Carolina. Most patients are referred by their medical doctor when a physical malady begins to impact cognitive ability-including memory. And while Dr. Mount's preference is to be consulted when a physician first begins talking to a patient about cognitive impairments, he says instead he's often brought in when the physician is running out of ideas. A little more conversation No matter what stage he begins with a patient, it always starts with a story. "We start with a patient-centered evaluation," he says-with him listening as the patient talks. "I want to hear their story, uninterrupted," he says. "I don't want them to self-edit anything." Dr. Mount employs counselors and therapists at his center, but he personally sees every patient who comes in. Patients realize the power their words carry. In Dr. Mount, they've found a doctor who's willing to listen to every detail of their pain journey-all the treatments tried, the loneliness that can accompany chronic pain, the heartbreak of not always being able to keep commitments. The doctor is ready to absorb it all. "MDs only have so much time," he says. "I have more time to invite a storytelling approach. And patients want to talk. They may have gotten the message before to 'shut up' about their pain. Once they start talking in my office, it's often hard to stop." Once their story has been told, he asks how they'd rewrite it. "I don't mean how they'd rewrite it without chronic pain," he explains. "I ask how they'd deal with the pain differently." Experience can be an excellent teacher. Once patients begin to consider what they would undo if they were rewriting their memoir, they can begin to take control and formulate a plan. Dr. Mount values the work MDs have done before they bring him into the mix, but he doesn't just thank them for the referral and move on. He uses a collaborative approach that involves the patient and the referring physician. His goal: to help patients with cognitive impairment that's a result of pain. Often, the impairment is a result of pain medication. Reducing a patient's medication is often among his prescriptions. That's accompanied by nutritional education, stretching-which is often done in his office-and other holistic treatments. He understands what his patients are going through. He's been there himself. When the doctor becomes the patient Dr. Mount suffers from chronic pain in his neck and spine. It began in 2005 when he was new to Winston-Salem and went to a chiropractor for an adjustment. After getting what he considers "substandard care," he realized he needed to educate himself on treatment options. "I experienced anxiety, uncertainty and was questioning myself," he says. "My work and social life were disrupted. I know about the stigma of feeling judged. Chronic pain will wear you down." He was losing sleep because of the pain-and was less likely to work out, too, though sports had always been a big part of his life. He wondered, "Why me?" He tried the gamut of specialists-neurologists, acupuncturists, massage therapists-but wasn't having success with any of them. That led to an "aha" moment: "The system I was moving through was broken. The specialists I was going to weren't talking to each other. The system was fragmented, and the patient was suffering as a result." He also understands that patients must be involved and invested in their own care-and that following doctor's orders is imperative. "Compliance," he says, "is the mortar that holds the bricks together." Noncompliance often arises, he says, from the psychological effects of pain and pain medication. So, who better than a neuropsychologist to partner with patients on sticking to their treatment plan? "I can help reinforce compliance," Dr. Mount says. That's something else that referring MDs appreciate about their partnership with him. "Compliance starts with attitude," he says. "If you can improve the attitude, then you achieve improved outcomes." The best medicine Pain is serious business, but that doesn't mean treatment has to be. Dr. Mount believes that there's real benefit to lightening up. Part of the work he does is humor therapy. "You'll hear a lot of laughter at my office," he says. (Laughter? Uninterrupted storytelling? Are you getting the idea that the Mind Body Institute Beyond is not your typical doctor's office?) Humor is, in fact, what led to his own relief. It's how he began to navigate the fractured system that wasn't getting him anywhere. He still sees many of the same specialists he did back in 2005 when the pain first began-but he maneuvers the system with a different mindset now, he says. He also practices yoga and mindfulness, takes supplements and is careful about eating right and getting enough sleep. Dr. Mount knows chronic pain is a family disease. It impacts more than the person living with the pain; it weighs on entire families. "When you talk to family members , they'll often use similar words to describe their situation," he says. "'Moody,' 'walking on eggshells,' 'unpredictable.' People with chronic pain can perceive themselves as a burden to others-and that leads to self-isolation and depression." Measuring how far you've come As a counselor, Dr. Mount values the conversational give and take he has with patients. But as a research scientist, he also wants to measure progress. At his second meeting with a new patient-after the initial storytelling session-he'll do an assessment of where the patient is. If the patient is having memory issues, he'll do neuropsychological tests to discover just how much memory function has been impaired. Physicians have been receptive to his approach. Dr. Mount will share his assessment report with the patient and the referring physician. "I've had doctors say: 'When I read your report, I learn something. There are things about my patient, who I've been treating for 20 years, I never knew that I learned from you.'" That's the power of storytelling. The in-depth report combines elements of the patient's story with Dr. Mount's detailed findings. It's a comprehensive look at the patient's pain history, what's been tried, how effective it was (or wasn't) and what side effects may be the result of prescription medication. It's much more detailed than the notes a doctor typically dictates. Again, it's because Dr. Mount and his team dedicate time to active listening. He has seen some patients in their mid-30s who have the memory function of someone who's 65 or older. But the good news? The situation can be reversed, he says-often by reducing the number of meds a patient is on. Then and now Dr. Mount's passion for studying and treating pain began during his residency at the University of Missouri-Columbia, where he worked extensively in physical medicine, rehabilitation neurology and internal medicine. "We were seeing the adverse effects of illicit drug use on pain management," he says. "We saw the adverse effects of comorbid chronic disease-diabetes, heart disease, physical injury-on pain management, as well." He focused his research on the effects of physical illness on cognitive memory, attention and learning new information. More recently, he's been interested in further exploring the brain's ability to recover and "rejuvenate" based on different treatment intervention strategies. His current research interest is studying and comparing pharmacological and medical device approaches. He uses the term "chronic pain brain" to describe the fog that's sometimes felt as a result of too much or too many pain medications. Pain brain can be as problematic as the pain itself. It can lead to memory loss, sleeplessness and a host of other issues. And the answer, Dr. Mount believes, isn't different or more medication. It's less. His prescription will likely also include more laughter, more talking, more stretching and moving and more engagement with life. When patients are ready to tell their story, Dr. Mount is all ears.