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) - Report - MDSpire
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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)
Clinical Report: 60-Day Percutaneous PNS vs Standard Care in Chronic Low Back Pain
Overview
This multicenter pragmatic randomized controlled trial demonstrated that percutaneous 60-day peripheral nerve stimulation (PNS) significantly improved pain relief in chronic low back pain (CLBP) patients compared to usual care with standard interventional management. At 3 months post-treatment, 55% of PNS-treated participants achieved ≥50% pain reduction versus 26% in the usual care group, with sustained benefits through 6 months.
Background
Chronic low back pain (CLBP) is a prevalent condition causing significant disability and reduced quality of life. Treatment options vary widely, including physical therapy, injections, ablations, neurostimulation, and surgery, but effectiveness is often limited. Percutaneous 60-day PNS targeting lumbar medial branch nerves has shown promise in prior smaller studies for providing meaningful pain relief and functional improvement. This trial aimed to provide comparative effectiveness data between 60-day PNS and standard interventional care in a real-world insured population with refractory CLBP.
Data Highlights
Outcome
60-Day PNS Group (n=112)
Usual Care Group (n=110)
Statistical Significance
≥50% Pain Reduction at 3 Months
55% (95% CI: 45-65)
26% (95% CI: 17-34)
P < .001
Improvements in Disability, Pain Interference, Quality of Life
Greater improvements observed
Less improvement
Not specified
Duration of Pain Relief and Functional Improvement
Sustained through 6 months
Not sustained
Not specified
Key Findings
55% of patients receiving 60-day PNS achieved ≥50% pain relief at 3 months compared to 26% with usual care (P < .001).
PNS treatment led to greater improvements in disability, pain interference, and health-related quality of life.
Analgesic consumption was reduced more significantly in the PNS group.
Pain relief and functional benefits from PNS were sustained through 6 months post-treatment.
The study enrolled 230 patients with refractory CLBP randomized 1:1 to PNS or usual care.
The trial was multicenter, pragmatic, and designed to reflect real-world clinical decision making.
Clinical Implications
Percutaneous 60-day PNS targeting lumbar medial branch nerves offers a superior alternative to standard interventional care for patients with refractory chronic low back pain, providing substantial and sustained pain relief and functional improvement. Clinicians should consider this modality as part of a multimodal pain management strategy, especially for patients who have failed multiple prior therapies.
Conclusion
This pragmatic RCT confirms that 60-day percutaneous PNS is more effective than usual care with standard interventions in reducing pain and improving function in CLBP patients, with benefits sustained through 6 months. These findings support integration of PNS into clinical practice for refractory CLBP management.
References
RESET Trial Investigators 2024 -- Evaluation of 60-Day Percutaneous Peripheral Nerve Stimulation for Lumbar Medial Branches Versus Standard Interventional Care in Chronic Low Back Pain
by Zachary L McCormick, Denise D Lester, Michael J DePalma, Christopher A Gilmore, Sean Li, Jessica B Jameson, Mehul J Desai, Tristan E Weaver, Shivanand P Lad, Scott J Davidoff, Drew M Trainor, Kasra Amirdelfan, Mitchell P Engle, Timothy R Deer, Thomas S Lee, Francesco Vetri, Meenakshi Bindal, Melissa A Tornero-Bold, Morad N Nasseri, Steven P Cohen, William H Clark, Meredith J McGee, Joseph W Boggs
