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Sensor-driven position-adaptive spinal cord stimulation for chronic pain.

David M Schultz1, Lynn Webster, Peter Kosek

  • 1MAPS Applied Research Center, Edina, MN 55435, USA. dschultz@painphysicians.com

Pain Physician
|January 25, 2012
PubMed
Summary
This summary is machine-generated.

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Automatic position-adaptive spinal cord stimulation (SCS) offers improved pain relief and convenience for patients compared to manual adjustments. This novel SCS therapy enhances comfort during position changes, activity, and sleep, reducing the need for manual programming.

Area of Science:

  • Neuromodulation
  • Pain Management
  • Biomedical Engineering

Background:

  • Spinal cord stimulation (SCS) systems can experience variable neurostimulation intensity with changes in body position.
  • Positional variations in stimulation can lead to overstimulation or understimulation, necessitating frequent manual programming adjustments for patients.
  • This variability presents a practical challenge impacting patient comfort and treatment efficacy in existing SCS therapies.

Purpose of the Study:

  • To evaluate the safety and effectiveness of a novel SCS therapy with automatic position-adaptive stimulation.
  • To compare patient-reported pain relief and convenience between automatic position-adaptive SCS and conventional manual programming.
  • To assess secondary outcomes including pain score changes and the frequency of manual programming adjustments.

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Main Methods:

  • Prospective, multicenter, open-label, randomized crossover study involving ten interventional pain management centers in the US.
  • Seventy-nine patients were implanted with a neurostimulation device capable of both automatic position-adaptive stimulation (AdaptiveStim) and manual programming.
  • Patients underwent a 4-week postoperative period with manual programming, followed by randomization to either manual or adaptive stimulation, with crossover at 6 weeks.

Main Results:

  • 86.5% of patients achieved improved pain relief or convenience with automatic position-adaptive SCS compared to manual programming (p < 0.001).
  • A statistically significant 41% reduction in daily amplitude adjustment programming button presses was observed with adaptive stimulation (p = 0.002).
  • Functional improvements included enhanced comfort during position changes (80.3%), improved activity (69%), and better sleep (47.9%), with no significant difference in adverse events.

Conclusions:

  • Automatic position-adaptive SCS is a safe and effective therapy for improving patient-reported pain relief and convenience.
  • The system effectively mitigates issues related to stimulation intensity variations caused by body position changes.
  • This technology offers a significant advancement over conventional manual programming for spinal cord stimulation.