Presentations include first reporting of data for the RESET™ Clinical Trial evaluating SPRINT PNS versus Standard Interventional Management for low back pain
CLEVELAND, Nov. 21, 2024 (GLOBE NEWSWIRE) -- SPR Therapeutics announced eight scientific abstracts that will be presented at the upcoming ASRA Pain Medicine Meeting, including positive results for the RESET Clinical Trial’s Primary Endpoint, demonstrating statistically superior outcomes compared to standard interventional management for the treatment of back pain.
The RESET Clinical Trial is the largest randomized controlled trial of 60-day percutaneous peripheral nerve stimulation (PNS) completed to date and adds to an already expansive library of clinical data on SPRINT PNS in the treatment of low back pain that includes positive four-year follow-up data from a prior prospective multicenter study demonstrating long-lasting, durable relief which may mitigate the need for more invasive treatment interventions.
“The consistency that we continue to see in both pain reduction and long-lasting durability of results throughout the body is an exciting and important trend,” said Maria Bennett, President, CEO, and Founder of SPR Therapeutics. “Our approach offers an effective, short-term treatment option that aligns with patient preferences to avoid more invasive interventions and allows physicians another option that can provide sustained relief to patients.”
Featured Presentations
“60-Day Percutaneous PNS vs. Standard Interventional Management for Chronic LBP: RESET Clinical Trial Primary Endpoint Results” (McCormick et al.) reports on the effectiveness of PNS compared to standard interventional management for chronic low back pain. Data from the randomized controlled trial* at three months after start of treatment indicates that 60-day percutaneous PNS provided clinically meaningful and statistically superior reductions in pain (greater than or equal to 50 percent) as well as improvements in function and quality of life (p<0.05). A moderated poster presentation of this data will be presented on November 23 at 10:45 a.m. in the Patrician room by Dr. Denise Lester.
“Four-Year Follow-Up from a Prospective, Multicenter Study of 60-day Medial Branch Nerve Stimulation for the Treatment of Chronic Axial Back Pain” (Gilmore et al.) highlights significant pain relief (greater than or equal to 50 percent) and/or improvements in disability (greater than or equal to ten points on the Oswestry Disability Index) among a majority of survey respondents an average of more than four years after SPRINT PNS. This abstract was selected as a President’s Choice abstract, which is scheduled for an oral presentation by Dr. Christopher Gilmore on November 21 at 3:45 p.m. in the Julius 24 room.
Additional Abstracts of Interest
“Percutaneous Peripheral Nerve Stimulation (PNS) Relieves Persistent Postoperative Pain and Improves Function: Long-term Follow-up from a Controlled Trial” (Eshraghi et al.) Total knee arthroplasty (TKA) is a common surgical procedure for patients with ongoing, chronic knee pain whether due to prior injury or aging and deterioration that limits mobility. An estimated 800,000 patients undergo TKA annually in the U.S., and approximately 10-20 percent experience persistent postoperative pain and reduced function. This study** goal was to characterize postoperative pain response to 60-day SPRINT PNS compared to sham stimulation (placebo) following TKA. The study indicates that most PNS participants had improvements in pain and function during treatment and sustained improvement relative to baseline out to 12 months following the start of treatment.
“Durable Multi-Year Relief of Shoulder Pain Following 60-Day PNS Treatment: A Cross-Sectional Follow-up Survey Study” and “Shoulder Surgery Avoidance Through Multiple Years Following 60-Day PNS Treatment: Outcomes from a Cross-Sectional Follow-up Survey Study” (Vorenkamp et al.) Shoulder pain is one of the most common locations of chronic pain and has the potential to become disabling. This IRB-approved, real-world, follow-up survey was completed by a group of over 400 patients who had undergone 60-day SPRINT PNS treatment of their shoulder pain and were 6-36 months out from the start of their treatment. Substantial proportions of patients reported durable pain relief following SPRINT PNS, avoided other major interventions including surgery or permanent neurostimulator implant, and reported reducing or ceasing pain medication use at the time of follow-up.
“Significant Relief of Headache Pain Following 60-Day PNS: Three-Month Outcomes from a Prospective, Single-Arm Study” (Kissoon et al.) Cervicogenic headache and occipital neuralgia are significant issues for millions of Americans and can be highly disabling conditions. This study is the first prospective evaluation of 60-day SPRINT PNS for headache pain, and 90 percent (18/20) of participants reported clinically significant (greater than or equal to 30 percent) reductions in pain and/or pain interference at the end of treatment.
“Use of 60-Day Percutaneous PNS for Sacroiliac (SI) Joint Pain: A Retrospective Review of Real-World Outcomes” (Sheth et al.) An estimated 15-30 percent of patients with low back pain have SI joint dysfunction. This IRB-approved, retrospective review evaluated real-world outcomes from 183 patients who had previously undergone 60-day SPRINT PNS treatment of their SI joint pain found that most patients achieved clinically significant (greater than or equal to 50 percent) pain reduction and/or improvement in quality of life.
“Percutaneous Peripheral Nerve Stimulation Used for Knee Pain: Single-Center Results from a Retrospective Chart Review” (Gutierrez et al.) This IRB-approved retrospective chart review provides real-world evidence demonstrating that percutaneous PNS may provide clinically significant relief (greater than or equal to 50 percent) of chronic knee pain with consistent results across patients with varying causes of knee pain and different durations of pain prior to use of PNS.
See all abstracts presented as posters shared at ASRA by visiting our summary page here.
The most common adverse events for the SPRINT PNS System in both clinical studies and real-world data include skin irritation and erythema. All three clinical studies (McCormick et al., Eshraghi et al., and Kissoon et al.) reported no study-related serious or unanticipated adverse events. Safety was not directly analyzed in the long-term follow-up survey (Gilmore et al.), the cross-sectional surveys (Vorenkamp et al.), the retrospective review of real-world outcomes (Sheth et al.), or the retrospective chart review (Gutierrez et al.).
*This work was supported by the Office of the Assistant Secretary of Defense for Health Affairs through the Peer Reviewed Medical Research Program under Award No. W81XWH-18-1-0800. Opinions, interpretations, conclusions and recommendations are those of the author and are not necessarily endorsed by the Department of Defense.
**This work was supported by The Office of the Assistant Secretary of Defense for Health Affairs, through the Peer Reviewed Orthopaedic Research Program under Award No. W81XWH1810799. Opinions, interpretations, conclusions and recommendations are those of the author and are not necessarily endorsed by the Department of Defense.
Drs. Gilmore, Eshraghi, Sheth, and Gutierrez are consultants for SPR Therapeutics.
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.
SPR Contacts:
Michelle McDonald
Vice President – Marketing
mmcdonald@sprtherapeutics.com
844.378.9108
Dave Folkens
Public Relations
dfolkens@sprtherapeutics.com
612.978.6547
