Cleveland, Ohio – June 10, 2026 – 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.
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