Hi, I'm Dr. Steven Falowski, I am a functional neurosurgeon out of Lancaster, Pennsylvania. I have a practice specializing in neuromodulation, but I'm also bringing you a new unique concept to talk about restorative neurostimulation for chronic low back pain and using that as a disease modifying therapy. Chronic low back pain is a burden on society globally. It's been estimated to account for about 30% of chronic low back pain cases. There's a high economic cost that's associated with this, which leads to a significant burden to those suffering from this chronic condition, putting a burden on patients as well as healthcare. Those with mechanical nociceptive chronic low back pain have had very limited successful options for their pain control within even medical management. Options did not exist that bridged the gap between conservative care and more invasive procedures. But even so, more importantly, options were not available for those patients who were deemed non-surgical chronic low back pain. So typically, spine stability occurs through balanced proprioceptive and mechanical feedback. Mechanical chronic low back pain, it's under repeated structural and tissue damage where the nociceptors relate pain to the brain. In turn, the brain redistributes motor control demands repeatedly, inhibiting muscles in the painful region while simultaneously exciting the more external or superficial muscles for stability. This constant motor control disruption typically leads to muscle dysfunction, particularly in the multifidus, which is the strongest stabilizer of the spine and obviously lies adjacent to the spinal structures. Multifidus dysfunction that has failed rehabilitation has been shown to respond well to neurostimulation of the medial branch of the L2 dorsal rami to affect the multifidus muscle. This is also known as restorative neurostimulation. This implantable restorative neurostimulation has shown effectiveness in curtailing mechanical chronic low back pain that arises from multifidus dysfunction. So therefore, the aim of this study was to evaluate the published data from three major restorative neurostimulative clinical trials and look at its effects on the pain ratings based on response, as well as ODI and even quality of life measures. You can see that with these three major studies, it spans multiple countries, including the US, Germany, UK, and Australia. Pain ratings, disability, and quality of life were collected on a cohort of 261 patients who had complete assessments preoperatively, as well as 6, 12, and 24 months postoperatively across the three studies. As you can imagine, the inclusion and exclusion criteria were varied across these studies, so therefore, the minimum requirements for inclusion were identified. Results from the complete data after two years were also statistically significant from baseline and demonstrated that 65% of the cohort reduced their pain by half of the recorded baseline responses. In addition, 60% were classified as remitters. What this means is that they rated their chronic low back pain at less than or equal to 2.5 on the VAS scale or 3 on the NRS scale. The ODI significantly improved from 41 at baseline to 21 at two years. 60% of the cohort significantly improved their ODI by greater than 15 points. The EQ5D significantly improved from 0.5 to 0.769, which approximated the US average normal quality of life, which sits at 0.82. Additionally, ages were assigned quartiles to compare the oldest quartile to the three younger quartiles from the 261-patient cohort. Now the key takeaways from this analysis were that regardless of age, there were consistent improvements in pain from the VAS and or the NRS at all time points compared to baseline. Significantly significant improvements in disability from the ODI and quality of life from the EQ5D were seen at all assessment time points compared to baseline. And when older patients use restorative neurostimulation for their mechanical, chronic, low back pain, and multifidus dysfunction, the likelihood of a meaningful improvement was consistent with younger ages and published outcomes. Finally, patients with a history of one or two radiofrequency ablations were also compared to those without radiofrequency ablations within this 261-patient cohort. Both groups had similar improvements in ODI over the two years, as well as similar improvements in quality of life based on the EQ5D, all of which were statistically significant from baseline. So in conclusion, evidence across multiple clinical studies has showed significant positive changes in patient-reported outcomes regardless of age and regardless of whether you've had a prior one or two radiofrequency ablations. This is true after having two years of restorative neurostimulation. Restorative neurostimulation provides a treatment option where none has existed before between the failure of conservative, optimal medical management, and then further invasive treatments. It's also now available for those patients who are deemed non-surgical low back pain patients. Patients using restorative neurostimulation long-term for their multifidus dysfunction and mechanical, chronic, low back pain have had sustained pain relief, improved function, and improved quality of life that was previously not available to them. Thank you for your attention for this landmark data.

neurosurgeon

restorative neurostimulation

chronic low back pain

implantable neurostimulation

multifidus muscle dysfunction