Nalu Medical presented interim data from the “landmark” COMFORT randomised controlled trial (RCT)—indicating long-term and holistic pain management outcomes with its peripheral nerve stimulation (PNS) system—at the recent North American Neuromodulation Society (NANS) annual meeting (18–21 January, Las Vegas, USA).
The ongoing COMFORT RCT is a post-market, open-label, “minimal-risk”, multicentre clinical study focused on evaluating the effectiveness of PNS therapy to treat chronic pain in the shoulder, low back, knee, or ankle/foot, with the Nalu neurostimulation system. As per a Nalu press release, the study is designed to develop three-year data to demonstrate the sustained pain relief and quality-of-life improvements achievable with the Nalu PNS system.
Interim 12-month pain relief data from a total of 15 patients showed that 87% of subjects were responders (≥50% pain relief), and found an average pain reduction of 73%.
In addition, holistic outcomes from 72 patients at three months revealed that 98% of subjects using Nalu PNS experienced ≥50% pain relief and/or reported improvement, compared with 21% of subjects who did not use Nalu PNS (p<0.001). Some 93% of subjects using Nalu PNS also experienced ≥50% pain relief and/or reduced disability compared with 35% in those who did not use Nalu PNS (p<0.001).
“Clinicians recognise the value of combining pain relief with functional outcomes to provide a more comprehensive assessment of device effectiveness in treating chronic, intractable pain,” said John Hatheway (Northwest Pain Care, Spokane, USA), first author and presenter of this oral report from COMFORT. “In the COMFORT RCT, we are measuring variables that present this broader picture. Results show that the Nalu PNS system is truly unique. For the first time, clinicians have access to advanced technology that enables us to offer effective long-term therapy to a broader range of patients.”
“We are thrilled to see such promising results from our advanced micro-IPG [implantable pulse generator] in a rigorous RCT setting,” added Nalu chief executive officer Tom West. “The COMFORT RCT is intended to provide reliable evidence of the sustained effectiveness and impact on quality of life provided by Nalu PNS therapy, and to expand the use of Nalu PNS to patients for whom physicians have limited options. Our approach to this research underscores our commitment to take a leadership role in generating evidence for continued and extended application of effective PNS therapy for chronic pain sufferers.”