SPR Therapeutics announced the results of a study of its FDA-cleared SPRINT Peripheral Nerve Stimulation (PNS) System for the treatment of post-amputation residual limb pain and phantom limb pain.
The study, published in Regional Anesthesia and Pain Medicine, demonstrated that short-term PNS therapy may provide enduring, clinically significant pain relief, reduce opioid use, and improve quality of life in patients with post-amputation pain.
All study participants underwent the minimally invasive ultrasound-guided placement of SPR’s MicroLeads, which are constructed using a 100-micron wire, about the size of a human hair. Participants were randomized to receive SPRINT PNS therapy or placebo for four weeks. The placebo group then crossed over and all study participants received PNS for four subsequent weeks. A study participant was considered a success if he or she reported significant pain relief of at least 50 percent during the first four weeks.
The study demonstrated that a significantly greater proportion of the participants who received SPRINT PNS experienced significant pain relief (58 percent) compared to 14 percent of those who received placebo. The delivery of therapy for four additional weeks in the SPRINT PNS group resulted in 67 percent of the participants reporting significant pain relief. While prospective follow-up is ongoing, of those participants who completed follow-up at 12 months, 80 percent reported continued relief with an average pain reduction of 76 percent. Furthermore, opioid use among moderate to high users (which represented about a quarter of the participants) decreased by more than 70 percent in the SPRINT PNS group compared to less than 1 percent in the placebo group.
“Post-amputation pain has traditionally been one of the most challenging neuropathic conditions we treat as interventional pain management specialists,” stated Christopher Gilmore, MD, of the Center for Clinical Research and principal author. “The data clearly demonstrate that the SPRINT PNS System is a safe and effective treatment option for post-amputation pain, with the potential to produce pain relief that endures well beyond the 60-day therapy period, after which the leads are withdrawn. Given the durability of pain relief we’re observing with SPRINT, many patients will appreciate that a permanently implanted system may be avoided. The non-opioid and minimally invasive nature of SPRINT also bodes well for its use early in the care continuum for other painful neuropathic conditions.”
The study was funded by a grant from the United States Department of Defense.