Presented at the 2012 AAPM Annual Meeting « Back

Automatic Position-Adaptive Spinal Cord Stimulation: Advantages and Clinical Benefits Reported in the RestoreSensor Study

David M. Schultz, MD, dschultz@painphysicians.com¹, Peter Kosek, MD², Robert Wailes, MD³, Kenneth H. Rogers, DO⁴, Sanghamitra Basu, MD⁵, Mark Sun, PhD⁶, Ye Tan, MS⁶, Mary Robischon, RN⁶, (1) MAPS Applied Research Center, Edina, Minnesota, (2) Pain Consultants of Oregon, Eugene, Oregon, (3) Pacific Pain Medicine Consultants, Oceanside, California, (4) Advanced Pain Consultants, Vorhees, New Jersey, (5) Sans Pain Clinic, North Las Vegas, Nevada, (6) Medtronic, Inc., Minneapolis, Minnesota

Introduction: The clinical benefits of spinal cord stimulation have been previously reported. Patient and physician assessments of the advantages of a novel position-adaptive stimulation feature collected in the context of a clinical study are reported here. Materials and Methods: Patients were implanted with the RestoreSensor™ neurostimulator with an optional position-adaptive stimulation feature (AdaptiveStim™, Medtronic, Inc., Minneapolis, MN) and randomized to receive 6 weeks of therapy with either conventional programming or position-adaptive stimulation followed by crossover for 6 additional weeks. At final follow-up, patients independently answered questions about position-adaptive stimulation. Physicians also assessed the benefits of position-adaptive stimulation for each patient. Results: Of the 71 patients (average age 52.4 years, 58% female) who responded to the questions about position-adaptive stimulation, most reported improved comfort during position changes (80.3%, N = 57) and improved control of therapy (57.8%, N = 41). Six patients (8.5%) indicated no improvements. A total of 87.3% (N = 62) of patients preferred position-adaptive stimulation compared with conventional programming. A total of 90.1% (N = 64) of patients intended to leave position-adaptive stimulation on all or most of the time or to turn it on or off as needed after study completion. Physicians reported position-adaptive stimulation added clinical benefit for 88.7% of patients. The adverse event profiles did not differ between study arms and were similar to those previously reported. Conclusions: Most patients reported one or more advantages of position-adaptive neurostimulation, preferred position-adaptive stimulation over conventional programming, and intended to continue using the feature. Physician assessments corroborated patient-reported benefits.

Funding: The RestoreSensor study was supported by Medtronic Neuromodulation.