Data Published in Interventional Pain Medicine Indicates Participants Who Received SPRINT PNS as Prescribed Were Three Times More Likely to Achieve Meaningful Pain Relief
CLEVELAND, June 10, 2026 (GLOBE NEWSWIRE) -- SPR® announced the publication of “Observations from the RESET Clinical Trial: A Post-Hoc Per Protocol Analysis of Clinical Outcomes with Percutaneous 60-Day Medial Branch PNS in Chronic Low Back Pain” in the journal Interventional Pain Medicine. This publication is a per protocol analysis of the RESET™ clinical trial of over 200 participants, which compares the 60-day SPRINT® Peripheral Nerve Stimulation (PNS) System to a control group receiving standard interventions for the treatment of chronic low back pain, such as physical therapy, injections, or radiofrequency ablation.*
The primary objective of this post-hoc analysis focused on the SPRINT PNS group and evaluated the relationship between treatment delivery (receiving SPRINT PNS as prescribed) and SPRINT PNS outcomes three months after the start of treatment. Secondary objectives included evaluating whether other clinical variables (e.g., age, gender, low back pain duration, response to a medial branch block) were associated with SPRINT PNS outcomes and exploring results among participants with features of two of the most common types of axial back pain, facetogenic and discovertebral (including discogenic) pain.
Key findings of this post-hoc analysis included:
- Per protocol treatment delivery of SPRINT PNS was significantly associated with achieving meaningful pain relief, as those participants had more than three times greater odds of achieving ≥50% reduction in average pain (n=91; p=0.023)
- All other explored variables, including response to a diagnostic medial branch block, were not significantly associated with SPRINT PNS treatment outcomes
- Exploratory cohorts with facetogenic or discovertebral pain features reported reductions in average pain, pain interference, and disability following treatment with SPRINT PNS.
- View the full publication and analysis here
Dr. Sean Li, Premier Pain Centers, Shrewsbury, New Jersey, lead author, and SPR consultant noted, “Results from this per protocol analysis were clear: patients in the RESET study who used SPRINT PNS as prescribed were three times more likely to achieve meaningful pain relief. This is a compelling message about the value of both clinical execution and patient adherence and their potential impact on outcomes. The analysis also adds to the growing literature suggesting that a positive medial branch block may not be required to identify patients with chronic low back pain who are likely to benefit from SPRINT PNS treatment.”
Josh Boggs, PhD, Chief Scientific Officer and SVP of Research & Development said, “Within the RESET study population, patient characteristics such as age, gender, and baseline scores were not significantly associated with outcomes, suggesting that many patients meeting the study criteria can respond well to SPRINT PNS when the treatment is delivered as prescribed. The exploratory analysis also found positive outcomes among patients with features of facetogenic and discovertebral pain, with benefits sustained through six months. Overall, these results add clinical context about chronic low back pain patients who may benefit from SPRINT PNS.”
All study adverse events were non-serious (mild or moderate) and were followed to resolution, as reported previously.
*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 Peripheral Nerve Stimulation (PNS) System is indicated for pain management in adults who have severe intractable chronic pain of peripheral nerve origin, as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach. It is intended to be implanted for up to 60 days and provide sustained pain relief for up to three months after the end of treatment. The SPRINT PNS System is not intended to be placed in the region innervated by the cranial and facial nerves. Refer to our Indications for Use page for the SPRINT System’s additional indication referencing acute pain.
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.
Product and brand names/logos are registered or common law trademarks of SPR. Visit our Trademarks page for more information.
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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
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