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CLEVELAND, April 08, 2019 (GLOBE NEWSWIRE) -- SPR Therapeutics, Inc., a leader in neurostimulation technology for pain management, today announced the results of a study of its SPRINT® Peripheral Nerve Stimulation (PNS) System in the treatment of post-amputation pain.
The study demonstrated that short-term PNS therapy may provide enduring clinically significant pain relief, reduce opioid use and improve quality of life in patients with post-amputation pain, a type of neuropathic pain. This is the first study of an FDA-cleared PNS system to demonstrate statistically significant and clinically meaningful improvements in pain relief for both residual limb pain and phantom limb pain. The study, “Percutaneous Peripheral Nerve Stimulation for the Treatment of Chronic Neuropathic Post-Amputation Pain: A Multi-Center Randomized Placebo-Controlled Trial” has been published in Regional Anesthesia and Pain Medicine, the official peer-reviewed publication of the American Society of Regional Anesthesia and Pain Medicine (ASRA).
Study participants had experienced post-amputation pain for periods ranging from four months to more than 30 years. All participants underwent the minimally-invasive ultrasound-guided placement of SPR’s MicroLeads™ which are constructed using a tiny 100-micron wire, about the size of a human hair. Participants were randomized to receive SPRINT PNS therapy or placebo for four weeks. The placebo group then crossed over and all study participants received PNS for four subsequent weeks. A study participant was considered a success if they reported significant pain relief of at least 50 percent during the first four weeks.
The study demonstrated that a significantly greater proportion of the participants who received SPRINT PNS experienced significant pain relief (58 percent) compared to 14 percent of those who received placebo. The delivery of therapy for four additional weeks in the SPRINT PNS group resulted in 67 percent of the participants reporting significant pain relief. While prospective follow up is ongoing, of those participants who completed follow-up at 12 months, 80 percent reported continued relief with an average pain reduction of 76 percent. Furthermore, opioid use among moderate to high users (which represented about a quarter of the participants) decreased by more than 70 percent in the SPRINT PNS group compared to less than one percent in the placebo group. The most common side effect was skin irritation or redness at the lead exit site or related to the use of adhesive patches or bandages. There were no serious side-effects.
Dr. Christopher Gilmore of the Center for Clinical Research in Winston-Salem, NC and principal author, stated: “Post-amputation pain has traditionally been one of the most challenging neuropathic conditions we treat as interventional pain management specialists. The data clearly demonstrate that the SPRINT PNS System is a safe and effective treatment option for post-amputation pain, with the potential to produce pain relief that endures well beyond the 60-day therapy period, after which the leads are withdrawn. Given the durability of pain relief we’re observing with SPRINT, many patients will appreciate that a permanently implanted system may be avoided. The non-opioid and minimally-invasive nature of SPRINT also bodes well for its use early in the care continuum for other painful neuropathic conditions.”
Neuropathic pain often occurs following an injury to peripheral nerves and is a common and challenging condition following amputation. There are approximately two million amputees in the United States, with nearly 200,000 amputations performed annually. The prevalence of persistent pain in this population has been reported to be as high as 74 percent for residual limb pain and 85 percent for phantom limb pain, with many patients experiencing pain of both types. This pain often impedes function, lowers quality of life, and leads to an increased risk of depression.
According to Paul Bernacchio, President of the National Amputation Foundation, “The study results reported by the SPR Therapeutics team are great news to the amputee and Veteran communities we represent. We are in desperate need of more effective, less invasive early interventions to address the significant issue of post-amputation pain. The enduring effects of this short-term therapy and its minimally-invasive nature make it a very compelling therapy for those suffering post-amputation pain.”
“SPR Therapeutics is very appreciative of the support of our physician investigators and sincerely grateful to our study volunteers,” said Maria Bennett, CEO of SPR Therapeutics, Inc. “This latest study validates the durable results being achieved with our SPRINT PNS system. We continue to work with pain specialists on future studies as we further advance the growing body of evidence for SPRINT.”
The SPRINT Peripheral Nerve Stimulation (PNS) System is the only percutaneous PNS device that is FDA-cleared for both chronic and acute pain, including post-operative and post-traumatic pain. The SPRINT PNS System leads are placed by a physician during an outpatient procedure without surgery, incisions, tissue destruction or anesthesia, and are connected to a wearable stimulator that delivers stimulation for up to 60 days of therapy, after which the leads are withdrawn. In multiple studies, the SPRINT system has demonstrated significant and sustained pain relief following the 60-day treatment. Physicians have used the SPRINT system to treat post-amputation pain, inoperable joint pain, lower back pain, complex regional pain syndrome (CRPS), and post-operative pain following joint replacement and surgical reconstruction (partial listing). For additional information regarding safety and efficacy visit www.sprtherapeutics.com.
About SPR Therapeutics, Inc.
SPR Therapeutics, Inc. is a privately-held medical device company headquartered in Cleveland, Ohio, focused on developing, manufacturing and commercializing non-opioid, minimally invasive, treatment options that improve quality of life. The company’s SPRINT technology is the only percutaneous Peripheral Nerve Stimulation (PNS) System FDA-cleared to treat both chronic and acute pain. More information can be found at: www.sprtherapeutics.com.
About this study
This multi-center, randomized, double-blinded, placebo-controlled, partial-crossover study enrolled 28 lower extremity amputees with post-amputation pain at six U.S. clinical sites. The study was funded by a grant from the United States Department of Defense, Congressionally Directed Medical Research Programs, Peer Reviewed Orthopaedic Research Program, under award: W81XWH-12-2-0132.
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