The SPRINT PNS System provides peripheral nerve stimulation treatment percutaneously for up to 60 days. SPRINT PNS has been shown to provide a majority of patients with sustained pain relief following up to 60-days of PNS treatment in various prospective studies across multiple pain indications. For patients with sustained pain relief, SPRINT PNS may prevent the need for implantation of a permanent neurostimulation system.
With the growing use of the SPRINT PNS System in broader clinical practice, leading interventional pain physicians and clinical researchers explored the effectiveness and long-term impact of this short-term PNS treatment.
Evaluating the Effectiveness and Long-Term Impact of 60-Day PNS Treatment for Pain Relief
Patients who previously received a 60-day PNS treatment were asked to participate in a retrospective, cross-sectional survey. This is the largest data set of real-world evidence regarding the effectiveness and long-term impact of the 60-day PNS treatment delivered by the SPRINT PNS System.
The survey results included the responses of 354 SPRINT PNS System patients who opted-in to provide data and who completed treatment between March 2018 and December 2020. (A total of 2,028 patients were offered the chance to participate in the survey). Among the survey respondents, the most common pain treatment areas included pain in the low back, shoulder, knee, and foot/ankle regions.
The survey assessed the following:
- Worst pain (Brief Pain Inventory Question #3, BPI-3)
- Average pain (BPI-5)
- Percent pain relief (BPI-8)
- Changes in medication usage
- Patient Global Impression of Change (PGIC)
In accordance with recent evidence-based guidance regarding the importance of evaluating multiple dimensions of potential benefit in patients (e.g., pain intensity, quality of life, physical function) responders were defined by reporting a ≥50% reduction in pain and/or clinically significant improvement in Quality of Life as assessed using the Patient Global Impression of Change (PGIC).
Survey Results Demonstrate Support for Short-Term PNS for Treating Various Pain Conditions with Sustainable Relief
The survey results demonstrated significant pain relief across a wide range of patients, consistent with previously published clinical studies assessing short-term percutaneous PNS.
Sustained Long-Term Improvements Reported in a Majority of Survey Respondents
35% of Respondents Treated with Short-Term PNS Stopped or Reduced Opioid Usage
As mentioned above, the survey noted reductions in both opioid usage and gabapentinoid usage. More specifically at the time of the survey, 35 percent (n=56/160) of respondents who were using opioids at baseline stopped or reduced opioid usage, and 32 percent (n=58/183) of respondents who were using gabapentin had stopped or reduced gabapentin usage.
“These findings validate the potential of the SPRINT PNS System to provide relief that enables patients to reduce or stop opioid use,” said Nate Crosby, PhD, Sr. Research Project Manager at SPR Therapeutics. “In the midst of the ongoing opioid crisis, physicians are in need of more minimally-invasive treatment options that can also be opioid-sparing. This real-world evidence supports that SPRINT can help fill that role.”
Conclusion: Real-world Evidence Provides Further Validation of Prior Research Regarding the Sustained Effects Following the 60-day Treatment Provided by the SPRINT PNS System
These survey findings present the largest body of real-world evidence to-date supporting the prolonged effectiveness of 60-day PNS treatment. The findings here are consistent with the outcomes previously published across multiple prospective clinical trials. And the real-world data coupled with the published clinical trial outcomes support the use of a 60-day PNS treatment across a wide range of pain conditions in broader clinical practice.
“Demonstration of clinical trial outcomes that translate into broader clinical practice is important to validating the utility of pain treatments like the SPRINT PNS System, both to maximize patient benefit while ensuring that physicians know what to expect when they recommend SPRINT PNS to their patients,” said lead author Dr. Matthew Pingree. “These survey results help us understand the benefits patients are receiving from 60-day PNS treatment in the real-world setting and corroborate peer-reviewed publications regarding clinical trials.”
Moreover, these data reveal the potential for short-term PNS to serve as a non-opioid (and potentially opioid-sparing) pain treatment option with the potential for sustained pain relief that may prevent the need for a permanently implanted system.
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The SPRINT PNS System is indicated for up to 60 days in the back and/or extremities for: (i) Symptomatic relief of chronic, intractable pain, post-surgical and post-traumatic acute pain; (ii) Symptomatic relief of post-traumatic pain; and (iii) Symptomatic relief of post-operative pain. The SPRINT PNS System is not intended to treat pain in the craniofacial region.
Physicians should use their best judgment when deciding when to use the SPRINT PNS System. For more information see the SPRINT PNS System IFU. Most common adverse events are skin irritation and erythema. Results may vary. Rx Only.
Results may vary. Important safety & risk information: https://bit.ly/2FU92NH