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)

Category	Detail
Condition	Refractory chronic low back pain (CLBP)
Key Mechanisms	Nociceptive, neuropathic, and nociplastic pain processes targeted by percutaneous peripheral nerve stimulation of lumbar medial branch nerves
Target Population	Adults with moderate to severe refractory CLBP confined to the lumbar region without radiation, having failed at least two prior pain therapies
Care Setting	Multicenter outpatient settings including academic and private practice sites across the United States

Percutaneous 60-day peripheral nerve stimulation (PNS) resulted in 55% of participants achieving ≥50% pain reduction at 3 months versus 26% with usual care (P < .001).
PNS produced greater improvements in disability, pain interference, health-related quality of life, and analgesic consumption sustained through 6 months.
This pragmatic randomized controlled trial met its primary endpoint demonstrating superiority of 60-day PNS over standard interventional management for CLBP.

Identify patients with moderate to severe refractory CLBP confined to the lumbar region without radiation.
Confirm prior use of at least two types of pain therapies including medications, physical therapy, injections, or ablations.

Consider percutaneous 60-day peripheral nerve stimulation targeting lumbar medial branch nerves for patients with refractory CLBP.
Usual care may include physician-directed standard interventional management such as injections, ablations, or physical therapy.

Assess pain reduction at 3 months post-treatment to evaluate response (≥50% pain relief considered clinically meaningful).
Monitor functional outcomes including disability, pain interference, quality of life, and analgesic use through 6 months.

Review safety data as per institutional protocols; study reported no specific adverse events in abstract but full safety profile available in appendices.
Consider patient selection criteria carefully to minimize risks associated with invasive procedures.

Patients with refractory chronic low back pain who have failed multiple prior therapies and have active health insurance coverage.

Percutaneous 60-day PNS offers superior pain relief and functional improvement compared to usual care, with sustained benefits up to 6 months.

Use shared decision-making incorporating patient preferences and clinical evidence when selecting PNS versus standard care.
Ensure thorough patient screening to confirm eligibility criteria including pain duration, severity, and prior treatment history.
Follow standardized protocols for PNS implantation and post-procedure monitoring to optimize outcomes.

Clinical Scorecard: Evaluation of 60-Day Percutaneous Peripheral Nerve Stimulation for Lumbar Medial Branches Versus Standard Interventional Care in Chronic Low Back Pain: Results from a Multicenter Pragmatic Randomized Controlled Trial (RESET)