SPR® Therapeutics Publishes Study on SPRINT® PNS's Effect on Postoperative Knee Pain

SPR Therapeutics, LLC has announced the results of a multicenter double-blind randomized, placebo-controlled trial examining the effects of the SPRINT PNS System on patients with moderate-to-severe postoperative pain following knee replacement surgery. Published in the journal Neuromodulation, the study focuses on peripheral nerve stimulation (PNS) as a treatment for chronic knee pain after total knee arthroplasty (TKA).

The trial evaluated the efficacy of a 60-day PNS treatment, with the primary endpoint being the proportion of participants who experienced at least a 50% reduction in pain during the last four weeks of treatment compared to their baseline levels. The study also included an objective performance measure, namely a six-minute walk test, to compare participants' walking abilities before and after the treatment period.

Key findings from the study showed significant improvements in both pain relief and functional performance:

1. Pain Relief: Participants receiving PNS treatment experienced significantly greater pain relief compared to the placebo group by the end of the treatment period. Specifically, 60% (12 out of 20) of the PNS group met the primary endpoint of at least 50% pain reduction, compared to only 24% (5 out of 21) in the placebo group. On average, the PNS group reported 54% pain relief, while the placebo group reported only 26%.

2. Functional Performance: The six-minute walk test results showed that the PNS group had a 47% improvement in walking ability by the end of the treatment, whereas the placebo group experienced a 9% decline. This objective measure underscores the functional benefits of PNS therapy.

The study reported no serious or unexpected adverse events related to the treatment. Most adverse events were minor dermatological issues, such as skin irritation from bandaging, affecting both groups similarly.

Total knee arthroplasty is a widely-used procedure for addressing severe knee conditions, with the number of surgeries expected to increase significantly by 2040. Despite its success, 10-20% of patients continue to experience significant postoperative pain beyond three months after the surgery, which impacts their recovery, return to work, and adds to healthcare costs.

Dr. David Dickerson, the study's author and Section Chief for Pain Medicine at Endeavor Health Medical Group, emphasized the significance of PNS therapy in reducing chronic knee pain and improving patients' quality of life, as evidenced by the improvements in walking ability. Maria Bennett, President, CEO, and Founder of SPR Therapeutics, highlighted the unmet need for effective postoperative pain management solutions and the potential for the SPRINT PNS System to address this gap.

The SPRINT PNS System represents a shift in chronic pain treatment, offering a non-invasive, drug-free alternative that reconditions the central nervous system to provide long-lasting pain relief. The system, cleared for use up to 60 days, has been extensively studied for various types of pain, including those associated with low back, knee, shoulder, post-amputation, and postoperative conditions. It is recognized as a preferred option by leading pain management centers.

SPR Therapeutics, Inc., headquartered in Cleveland, OH, with additional offices in Chapel Hill, NC, and Minneapolis, MN, is committed to providing minimally invasive, non-opioid pain treatment options. The company’s leadership team brings extensive experience in the pain management and medical technology sectors, unified by the mission to improve patients' lives through innovative pain treatment solutions.

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