Treating Chronic, Intractable Pain with a Miniaturized Spinal Cord Stimulation System: 1-Year Outcomes from the AUS-nPower Study During the COVID-19 Pandemic
By Admin | January 23, 2024
John Salmon,1 Daniel Bates,2 Neels Du Toit,2 Paul Verrills,2 James Yu,3 Murray G Taverner,4 Vahid Mohabbati,5 Matthew Green,6 Gary Heit7 ,† Robert Levy,8 Peter Staats,9 Shilpa Kottalgi,10 James Makous,11 Bruce Mitchell2
1Pain Management, Pain Care Perth, Perth Cottesloe, WA, Australia; 2Pain Management, Metro Pain Group, Melbourne, VIC, Australia; 3Pain Management, Sydney Spine and Pain, Sydney, NSW, Australia; 4Pain Management, Frankston Pain Management, Frankston, VIC, Australia; 5Pain Management, Sydney Pain Management Centre, Sydney, NSW, Australia; 6Pain Management, Pain Medicine of South Australia, Adelaide, SA, Australia; 7Department of Neurosurgery, Hue University of Medicine and Pharmacy, Hue, Vietnam; 8Neurosurgery, Institute for Neuromodulation, Boca Raton, FL, USA; 9Premier Pain Centers, Shrewsbury, NJ, USA; 10Clinical Department, Nalu Medical, Inc, Carlsbad, CA, USA; 11Makous Research, LLC, Carlsbad, CA, USA
†Gary Heit passed away in February 2023
Correspondence: John Salmon, Pain Management, Pain Care Perth, 2/89 Forrest Street, Perth Cottesloe, WA, 6011, Australia, Tel +61 428 246 846, Fax +61 8 92845759, Email Salmon8@bigpond.com
Purpose: Spinal cord stimulation (SCS) is a highly effective treatment for chronic neuropathic pain. Despite recent advances in technology, treatment gaps remain. A small SCS system with a miniaturized implantable pulse generator (micro-IPG; < 1.5 cm3 in volume) and an externally worn power source may be preferred by patients who do not want a large, implanted battery. We report here the long-term outcomes from the first-in-human study evaluating the safety and performance of a new neurostimulation system.
Patients and Methods: This was a prospective, multi-center, open-label, single-arm study to evaluate this SCS system, in the treatment of chronic, intractable leg and low-back pain. Consented subjects who passed screening continued on to the long-term phase of the study. One-year, patient-reported outcomes (PRO’s) such as pain (Numeric Rating Scale, NRS), functional disability, quality of life, and mood were captured.
Results: Twenty-six (26) evaluable subjects with permanent implants were included in this analysis. The average leg pain NRS score decreased from 6.8 ± 1.2 at baseline to 1.1 ± 1.2 at the end of the study (p < 0.001), while the average low-back pain NRS score decreased from 6.8 ± 1.2 to 1.5 ± 1.2 (p < 0.001). The responder rate (proportion with ≥ 50% pain relief) was 91% in the leg(s) and 82% in the low back. There were significant improvements in functional disability (Oswestry Disability Index) and in mood (Beck Depression Inventory), demonstrating a 46% and 62% improvement, respectively (p < 0.001). Eleven-point Likert scales demonstrated the wearable to be very comfortable and very easy to use.
Conclusion: There were considerable challenges conducting a clinical study during the COVID-19 pandemic, such as missed study programming visits. Nevertheless, subjects had significant PRO improvements through 1-year. The small size of the implanted device, along with a proprietary waveform, may allow for...(More)
For more info please read, Treating Chronic, Intractable Pain with a Miniaturized Spinal Cord Stimulation System: 1-Year Outcomes, by Dove Press
