RESET Trial Shows SPRINT PNS Delivers Superior Pain Relief for Chronic Low Back Pain Compared to Standard Care
核心洞察
The RESET clinical trial, published in Pain Medicine, demonstrated that SPRINT PNS (搜索) achieved superior pain relief compared to standard interventional treatments in 222 patients with chronic low back pain (搜索).
A greater proportion of patients treated with 60-day SPRINT PNS (搜索) achieved ≥50% pain relief at three months versus those receiving standard care including physical therapy, injections, or radiofrequency ablation.
The SPRINT PNS (搜索) group showed sustained improvements in pain, disability, and quality of life metrics through six months, with no serious adverse events reported.
The landmark RESET clinical trial has demonstrated that SPR (搜索)'s SPRINT PNS (搜索) system delivers superior pain relief compared to standard interventional treatments for chronic low back pain (搜索), according to results published in Pain Medicine. The multicenter pragmatic randomized controlled trial included 222 patients and represents the largest study of SPRINT PNS technology to date.
Trial Design and Primary Results
The RESET study compared 60-day SPRINT PNS (搜索) treatment to standard interventional management approaches including physical therapy, injections, and radiofrequency ablation (RFA). The trial successfully met its primary endpoint, with a greater proportion of patients treated with SPRINT PNS achieving ≥50% pain relief three months after treatment initiation compared to those receiving standard interventions.
The study was funded primarily 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, highlighting the technology's potential significance for military and civilian applications.
Comprehensive Secondary Endpoint Success
Beyond the primary pain relief measure, the SPRINT PNS (搜索) group demonstrated superior outcomes across all secondary endpoints and quality of life metrics. These improvements included:
- Reduced disability as measured by the Oswestry Disability Index (ODI)
- Decreased pain interference with daily activities
- Enhanced health-related quality of life
- Reduced analgesic medication usage
Notably, the significantly greater improvements in pain, disability, and pain interference observed in the SPRINT PNS (搜索) group were sustained through at least six months compared to the control group, suggesting durable therapeutic benefits.
Safety Profile and Clinical Significance
The trial reported no serious, unanticipated study-related adverse events in any participants. The most common adverse event in the SPRINT PNS (搜索) group was skin irritation, consistent with the minimally invasive nature of the treatment.
"The RESET Study is designed to provide clinicians with valuable insight into how SPRINT PNS (搜索) may perform in the treatment of chronic low back pain (搜索) 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."
Technology and Clinical Impact
The SPRINT PNS (搜索) System represents what SPR (搜索) describes as a "First-Line PNS" option designed to recondition the central nervous system without requiring permanent implants, nerve destruction, or carrying addiction risks. The 60-day treatment has been studied extensively across multiple pain conditions including low back pain, knee pain, shoulder pain, post-amputation pain, and chronic and acute postoperative pain.
"As the largest randomized controlled trial of SPRINT PNS (搜索) 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 (搜索). "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 (搜索)."
Clinical Applications and Indications
The SPRINT PNS (搜索) 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, and symptomatic relief of postoperative pain. The system is not intended for placement in regions innervated by cranial and facial nerves.
SPR (搜索), headquartered in Cleveland, Ohio, positions itself as addressing a critical unmet need for drug-free, surgery-free treatment options for the millions suffering from chronic pain (搜索). The company's approach represents a non-opioid, minimally invasive alternative in the evolving pain management landscape.