Nalu Medical has revealed findings from a landmark clinical trial evaluating its Nalu peripheral nerve stimulation (PNS) system, utilising the company’s proprietary micro-implantable pulse generator (micro-IPG) to treat chronic pain patients.
Nalu’s COMFORT study is a post-market, multicentre randomised controlled trial (RCT) assessing pain reduction and functional outcomes across a variety of peripheral pain targets. The primary endpoint was met, showing that Nalu PNS outperformed conventional care alone (p<0.001).
The results, which Nalu states highlight “sustained therapeutic efficacy and safety”, have been published in Regional Anesthesia and Pain Medicine. In the study, 88% of patients using Nalu PNS achieved ≥50% pain relief at six months (n=46). In addition, patients using Nalu PNS showed a 70% average pain reduction, and outcomes were consistent across all anatomical areas in the study, including shoulder, low-back, knee and foot/ankle pain.
Nalu PNS delivered clinically meaningful functional outcome benefits in addition to significant pain relief. According to the company, 98% of patients reported overall improvement, 70% reported quality-of-life improvement, 80% reported reduction in depression, and 72% reported reduction in disability.
“For the first time, interventional pain management clinicians can confidently provide SCS [spinal cord stimulation]-level outcomes with a PNS system that is proven with RCT data,” said John Hatheway (Northwest Pain Care, Spokane, USA), lead author of the study. “In addition to significant pain reduction, the COMFORT study demonstrated meaningful improvements in quality of life, mood, and functionality.”
In COMFORT, there were no reports of pocket pain—a common concern with traditional implanted neurostimulation devices. There were also no serious device-related adverse effects and the vast majority of patients found the external components comfortable to wear, Nalu claims.
The ongoing COMFORT RCT will monitor patients over a three-year period and another study, COMFORT 2, is currently enrolling patients with anticipated completion of enrolment in 2024. Together, COMFORT and COMFORT 2 are intended to enrol the largest cohort to date of RCT subjects comparing the responder rate of Nalu PNS combined with conventional care to the responder rate of conventional care alone. As such, Nalu says it is “leading the charge” to develop level-one evidence supporting PNS therapy.
“Our dedication to rigorous research cements our leadership in the field,” said Tom West, chief executive officer and president of Nalu. “The clinical outcomes unveiled by the COMFORT RCT study demonstrate that our technology yields unparalleled benefits for chronic pain patients, setting a new standard of care for PNS.”
