Presented at the 2013 AAPM Annual Meeting « Back

The Role of Convenience in the Efficacy of Position-Adaptive Stimulation: Results of the RestoreSensor Study

Lynn R. Webster, MD, lrwebstermd@gmail.com¹, David M. Schultz, MD², Ye Tan, MS³, Mark Sun, PhD³, (1) CRILifetree, Salt Lake City, Utah, (2) MAPS Medical Pain Clinics, Minneapolis, Minnesota, (3) Medtronic, Inc., Minneapolis, Minnesota

Introduction: Convenience in making programming adjustments to compensate for position-related changes in neurostimulation plays an important role in overall patient satisfaction with spinal cord stimulation (SCS) therapy. The previously reported RestoreSensor study demonstrated that position-adaptive stimulation (AdaptiveStim, Medtronic, Inc., Minneapolis, MN) improved pain relief with no loss of convenience and/or improved convenience with no loss of pain relief for 86.5% of patients. We report on a sub-analysis of the convenience aspect of the primary efficacy objective. Methods: Patients in the IRB-approved RestoreSensor study experienced position-adaptive stimulation or conventional stimulation separately for 6 weeks. Patients then rated pain relief and convenience separately on 5-point Likert scales and also assessed functional benefits of position-adaptive stimulation. The number of programming adjustments for stimulation amplitude made in each study arm was recorded. Results: Of the 74 patients included in an intent-to-treat analysis, 64 (86.5%) reported that position-adaptive stimulation was more convenient: 51 (68.9%) reported it was much more convenient and 13 (17.6%) reported it was somewhat more convenient, compared to conventional stimulation. The reported improvement in convenience was mirrored by self-reported functional improvements in comfort during position change (80.3%) and control of therapy (57.8%). Additionally, patients reduced the number of button presses for stimulation amplitude adjustment by 40.7% during position-adaptive stimulation compared to conventional stimulation. Conclusions: Position-adaptive stimulation improved the convenience of SCS therapy for most patients in the RestoreSensor study. The results from other study objectives corroborate that convenience plays an important role in functional improvements and overall satisfaction with SCS therapy.

Funding: The RestoreSensor study was supported by Medtronic Neuromodulation.