- Holistic approach to measurement provides meaningful real-world impact evaluation - CLEVELAND, Aug. 06, 2024 (GLOBE NEWSWIRE) -- A new real-world retrospective analysis evaluating quantifiable improvements in multiple domains of health in patients who received 60-day peripheral nerve stimulation (PNS) for chronic shoulder pain at the end of treatment and up to six months from the start of treatment has been published in Pain Management. “Real-world evidence of durable multi-dimensional improvement after 60-day PNS treatment used for shoulder pain” analyzes four domains of health (pain, quality of life, physical function, and sleep) reflecting a more holistic approach evaluating the impact of pain treatment for patients in everyday use. Responders were defined as patients that reported at least 50 percent pain relief for the pain domain, and patients indicating improvement (Patient Global Impression of Change greater than or equal to one) were considered responders in the quality-of-life, physical function, and sleep measurements. Rate of Responders: 80.7 percent of patients (n=620/768) responded in at least one domain at the end of treatment.Holistic Responders: 45.8 percent (n=352/768) of patients were defined as holistic responders, responding in all four domains. Sustained Response: Among a subset of responders at end of treatment with available follow-up, a cumulative 75 percent continued to respond at six months. Response rates were 85 percent (n=140/165) at three months and 88 percent (n=53/60) at six months.
This real-world analysis included patients who were treated for chronic shoulder pain and opted-in to provide information to the device manufacturer. Patients received one or two leads to deliver PNS treatment, most commonly targeting the suprascapular nerve and the axillary nerve, either at the deltoid or the quadrangular space. The study’s lead author was Dr. Ali Valimahomed, MD, FAAPMR, of the Advanced Orthopedics and Sports Medicine Institute and SPR consultant. “Chronic shoulder pain is common, but patients suffering with it often find limited treatment options,” said Maria Bennett, President, CEO, and Founder of SPR® Therapeutics. “Patients may view surgical interventions as a last resort, but less invasive treatments may not do enough to relieve pain. The SPRINT PNS System is used for 60 days and presents a clinically proven, non-opioid, and non-surgical option for patients.” Among the patients included in the analysis, no serious adverse events were reported. The most common event was skin irritation, reported by 3.3 percent (n=25) of patients. About the SPRINT PNS System The SPRINT® PNS System, by SPR® Therapeutics, marks an innovative shift in the treatment of pain. Our breakthrough, 60-day treatment is a First-Line PNS™ option uniquely proposed to recondition the central nervous system to provide significant and sustained relief from chronic pain — without a permanent implant, nerve destruction or the risk of addiction. The system has been studied extensively for low back pain, knee pain, shoulder pain, post-amputation pain, and chronic and acute postoperative pain, is cleared for use up to 60 days, and is recognized by leading pain management centers. Market research indicates that this breakthrough neuromodulation treatment is a patient-preferred alternative to more invasive options. The SPRINT PNS System is indicated for up to 60 days for: Symptomatic relief of chronic, intractable pain, post-surgical and post-traumatic acute pain; symptomatic relief of post-traumatic pain; symptomatic relief of postoperative pain. The SPRINT PNS System is not intended to be placed in the region innervated by the cranial and facial nerves. Physicians should use their best judgment when deciding when to use the SPRINT PNS System. For more information see the SPRINT PNS System IFU. Most common adverse events are skin irritation and erythema. Results may vary. Rx only. For additional information regarding safety and efficacy, visit: SPR Safety Information. About SPR Therapeutics, Inc.SPR Therapeutics is a privately held medical device company, providing patients with a non-opioid, minimally invasive pain treatment option. Our SPRINT® PNS System fulfills a critical unmet need for a drug-free, surgery-free option for millions who suffer from chronic pain. Backed by the largest body of clinical evidence in peripheral nerve stimulation for the treatment of pain, SPR has demonstrated commercial demand in untapped peripheral (shoulder and knee) and back pain markets and built an incredibly strong foundation for commercial growth. Headquartered in Cleveland, OH with satellite offices in Chapel Hill, NC and Minneapolis, MN, SPR’s Senior Management team includes experienced industry veterans with nearly 200 years of collective pain market and MedTech expertise, all driven by our purpose – to improve the quality of patients’ lives by providing them with a minimally-invasive, drug-free, surgery-free solution to manage their acute and chronic pain. More information can be found at www.SPRTherapeutics.com.
