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Treating Chronic, Intractable Pain with a Miniaturized Spinal Cord Stimulation System: 1-Year Outcomes from the AUS-nPower Study During the COVID-19 Pandemic.
Salmon, John; Bates, Daniel; Du Toit, Neels; Verrills, Paul; Yu, James; Taverner, Murray G; Mohabbati, Vahid; Green, Matthew; Heit, Gary; Levy, Robert; Staats, Peter; Kottalgi, Shilpa; Makous, James; Mitchell, Bruce.
Afiliación
  • Salmon J; Pain Management, Pain Care Perth, Perth Cottesloe, WA, Australia.
  • Bates D; Pain Management, Metro Pain Group, Melbourne, VIC, Australia.
  • Du Toit N; Pain Management, Metro Pain Group, Melbourne, VIC, Australia.
  • Verrills P; Pain Management, Metro Pain Group, Melbourne, VIC, Australia.
  • Yu J; Pain Management, Sydney Spine and Pain, Sydney, NSW, Australia.
  • Taverner MG; Pain Management, Frankston Pain Management, Frankston, VIC, Australia.
  • Mohabbati V; Pain Management, Sydney Pain Management Centre, Sydney, NSW, Australia.
  • Green M; Pain Management, Pain Medicine of South Australia, Adelaide, SA, Australia.
  • Heit G; Department of Neurosurgery, Hue University of Medicine and Pharmacy, Hue, Vietnam.
  • Levy R; Neurosurgery, Institute for Neuromodulation, Boca Raton, FL, USA.
  • Staats P; Premier Pain Centers, Shrewsbury, NJ, USA.
  • Kottalgi S; Clinical Department, Nalu Medical, Inc, Carlsbad, CA, USA.
  • Makous J; Makous Research, LLC, Carlsbad, CA, USA.
  • Mitchell B; Pain Management, Metro Pain Group, Melbourne, VIC, Australia.
J Pain Res ; 17: 293-304, 2024.
Article en En | MEDLINE | ID: mdl-38274409
ABSTRACT

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 improved SCS outcomes and a drop in incidence of IPG-pocket pain.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Tipo de estudio: Clinical_trials Aspecto: Patient_preference Idioma: En Revista: J Pain Res Año: 2024 Tipo del documento: Article País de afiliación: Australia Pais de publicación: Nueva Zelanda
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Tipo de estudio: Clinical_trials Aspecto: Patient_preference Idioma: En Revista: J Pain Res Año: 2024 Tipo del documento: Article País de afiliación: Australia Pais de publicación: Nueva Zelanda