Low‐energy differential target multiplexed SCS derivative reduces pain and improves quality of life through 12 months in patients with chronic back and/or leg pain.

Introduction: Energy‐reducing spinal cord stimulation (SCS) approaches have the potential to impact patient experience with rechargeable and non‐rechargeable SCS devices through reducing device recharge time or enhancing device longevity. This prospective, multi‐center study evaluated the safety, ef...

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Publicado en:Pain Practice Vol. 25; no. 1; pp. 1 - 14
Autores principales: Peacock, Jeffery, Provenzano, David, Fishman, Michael, Amirdelfan, Kasra, Bromberg, Todd, Schmidt, Todd, White, Thomas, Grewal, Prabhdeep, Justiz, Rafael, Calodney, Aaron, El‐Naggar, Amr, Shah, Binit, Esposito, Michael, Gatzinsky, Kliment, Kallewaard, Jan Willem, Poree, Lawrence, Cleland, Andrew, Rice, Calysta, Theis, Erin, Noel, Kate
Formato: clinical trial research tables/charts Journal Article
Publicado: Wiley-Blackwell Jan2025
Acceso en línea:Ver este registro en EBSCOhost
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      pub: Wiley-Blackwell
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        atl: Low‐energy differential target multiplexed SCS derivative reduces pain and improves quality of life through 12 months in patients with chronic back and/or leg pain.
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          Peacock, Jeffery
          Provenzano, David
          Fishman, Michael
          Amirdelfan, Kasra
          Bromberg, Todd
          Schmidt, Todd
          White, Thomas
          Grewal, Prabhdeep
          Justiz, Rafael
          Calodney, Aaron
          El‐Naggar, Amr
          Shah, Binit
          Esposito, Michael
          Gatzinsky, Kliment
          Kallewaard, Jan Willem
          Poree, Lawrence
          Cleland, Andrew
          Rice, Calysta
          Theis, Erin
          Noel, Kate
        affil: Pain Management, Novant Health, Winston‐Salem North Carolina,, USA
      sug:
        subj:
          Back Pain Therapy
          Chronic Pain Therapy
          Spinal Cord Stimulation Evaluation
          Spinal Cord Stimulation Methods
          Quality of Life
          Treatment Outcomes
          Patient Safety
          Human
          United States
          Female
          Male
          Middle Age
          Aged
          Clinical Trials
          Prospective Studies
          Multicenter Studies
          Visual Analog Scaling
          Questionnaires
          Time Factors
          Pain Measurement
          Pain Management
          Patient Satisfaction
          Scales
          Data Analysis Software
          Confidence Intervals
          Descriptive Statistics
          Middle Aged: 45-64 years
          Aged: 65+ years
          Female
          Male
      ab: Introduction: Energy‐reducing spinal cord stimulation (SCS) approaches have the potential to impact patient experience with rechargeable and non‐rechargeable SCS devices through reducing device recharge time or enhancing device longevity. This prospective, multi‐center study evaluated the safety, effectiveness, and actual energy usage of differential target multiplexed (DTM) endurance therapy, a reduced energy DTM SCS derivative. Methods: Subjects who reported an overall pain visual analog score (VAS) of ≥6/10 cm and an Oswestry Disability Index score of 21–80 out of 100 at baseline with moderate to severe chronic, intractable back and/or leg pain were eligible. Evaluation visits occurred at 1, 3, 6, and 12 months post‐device activation. The primary objective was to characterize change in overall pain intensity, as measured by VAS, from baseline to 3‐month visit. Results: Fifty‐seven subjects enrolled at 12 US sites from November 2020 through June 2021, 35 were implanted with a rechargeable SCS device, and 27 completed the 12‐month visit. Subjects experienced a 50.4% mean reduction in overall pain from baseline at the 3‐month follow‐up that was sustained through 12 months. Additional outcomes including changes in overall, back, and leg pain intensity, quality of life, disability, therapy satisfaction, safety, and current battery usage are shown through 12‐month follow‐up. Conclusion: The use of DTM endurance SCS therapy in this study resulted in reductions in pain relief through 12 months, demonstrating that energy‐reducing stimulation patterns can provide clinical benefit. Clinically effective, reduced energy SCS derivatives have the potential to impact patient experience through either reduced recharge requirements or increased device longevity.
      pubtype: Academic Journal
      doctype:
        clinical trial
        research
        tables/charts
        Journal Article
      ougenre: Article
    language: English
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