RESET™ Clinical Trial Demonstrates Superior Pain Relief with SPRINT® PNS Compared to Standard Interventional Management for Chronic Low Back Pain
The study met its Primary Endpoint of pain relief and showed that SPRINT PNS delivered significant improvements in patient-centric secondary endpoints
CLEVELAND, Nov. 04, 2025 (GLOBE NEWSWIRE) -- Published in the journal Pain Medicine, “Comparison of Percutaneous 60-Day Peripheral Nerve Stimulation of the Lumbar Medial Branches to Usual Care with Standard Interventional Management for Chronic Low Back Pain – a Multicenter Pragmatic Randomized Controlled Trial (RESET)” presents the results of a landmark clinical trial comparing 60-day SPR® SPRINT PNS treatment to a control group receiving standard interventions for the treatment of chronic low back pain, such as physical therapy, injections, or radiofrequency ablation (RFA).
This study, funded in part by the Department of Defense*, included 222 patients randomized into two groups. The study successfully met its primary endpoint, with a greater proportion of patients treated with SPRINT PNS achieving ≥50 percent pain relief three months after the start of treatment versus those treated with standard interventions.
The SPRINT PNS group experienced superior outcomes versus the control group for all secondary endpoints and quality of life metrics collected including disability as measured by the Oswestry Disability Index (ODI), pain interference, health-related quality of life, and reductions in analgesic medication usage. Additionally, the significantly greater improvements in pain, disability, and pain interference in the SPRINT PNS group were sustained through at least six months compared to those in the control group.
In this study, no serious, unanticipated study-related adverse events occurred in any participants and the most common adverse event in the SPRINT PNS group was skin irritation.
“The RESET Study is designed to provide clinicians with valuable insight into how SPRINT PNS may perform in the treatment of chronic low back pain versus standard interventions and better understand how SPRINT PNS fits in the ideal care continuum,” said Dr. Denise Lester, Board-Certified Anesthesiologist and Pain Management physician. “I seek to offer my patients the best treatment for their pain and this Level 1 study suggests that patients may be twice as likely to experience clinically substantial pain relief with 60-day PNS versus long-standing, standard approaches.”
“As the largest randomized controlled trial of SPRINT PNS to date, the RESET Study has demonstrated clinically meaningful and statistically superior reductions in pain and improvements in quality of life for participants,” said Maria Bennett, President, CEO, and Founder of SPR. “These strong results, along with the extensive clinical evidence across more than 150 peer-reviewed publications, including controlled trials and real-world evidence, suggest SPRINT PNS is a viable first-line, minimally invasive option for the treatment of chronic low back pain.”
View the full publication here.
* The vast majority of funding for this clinical trial was from 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.
About the SPRINT PNS System
The SPR® SPRINT® PNS System 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
SPR 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. SPR – Solutions for pain. Inspired by life.™
SPR Contacts:
Dave Folkens
Public Relations
Dave.Folkens@SPRPainRelief.com
612.978.6547