SPR Therapeutics' 14-Month Data from Trial Shows Significant, Durable Impacts
SPR Therapeutics, a private medical device company focused on treating pain and improving the quality of life for patients suffering from acute or chronic pain, announced the peer-reviewed publication of final patient-reported outcomes from the largest prospective, multicenter trial completed to date of temporary peripheral nerve stimulation (PNS) for chronic low back pain.
Titled “Durable patient-reported outcomes following 60-day percutaneous peripheral nerve stimulation (PNS) of the medial branch nerves,” the study has been published in Interventional Pain Medicine, the official journal of the Spine Intervention Society (SIS) and includes data through the final 14-month follow-up (12 months after the 2-month PNS treatment).
“Some of this study’s most important findings are the continued durability and impacts beyond the 60-day SPRINT® PNS treatment period. These outcomes reinforce our belief that chronic low back pain involves sensitization of neural processes in the central nervous system and further our understanding of how targeted PNS may recondition central sensitization with the potential to provide pain relief that lasts long after the removal of the percutaneous PNS leads,” said Meredith McGee, PhD, Manager of Research and Development at SPR Therapeutics. “Other pain treatments that mask pain without addressing the underlying central sensitization typically require retreatment or permanent peripheral nerve stimulation.”
The primary objective of this prospective multicenter clinical trial was to evaluate the responses of chronic low back pain patients receiving percutaneous PNS of the medial branch nerves. The durability of long-term effects following temporary PNS treatment are characterized in this report. Key findings of the clinical study included:
The proportion of participants experiencing clinically meaningful improvement in one or more of the outcomes was 77 percent at 14 months. In addition, 58 percent of participants had clinically meaningful improvement in two or more outcomes at 14 months.
75 percent of participants who reported taking opioids at baseline reported reductions in opioid consumption in the months after PNS.
75 percent of participants said they “agreed” or “strongly agreed” that they would have pursued treatment with SPRINT PNS earlier in their care pathway if it had been available.
No serious, unanticipated study-related adverse events occurred. The most common adverse events were mild skin irritation or pruritis at the bandage or stimulator’s mounting pad.
Read more about the trial here