Presented at the 2013 AAPM Annual Meeting « Back

Improved Pain Relief with 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: The effectiveness of spinal cord stimulation in the management of chronic back pain has been documented in a large body of literature including prospective randomized controlled trials. The RestoreSensor neurostimulator with the AdaptiveStim feature (Medtronic, Inc., Minneapolis, MN) was developed to automatically address the problem of variation in the intensity of neurostimulation with body position. Patient benefits of the new feature could include added convenience and/or improved pain relief. We previously reported that 86.5% of patients met the primary efficacy objective when using the AdaptiveStim feature. We report on a sub-analysis assessing only improved pain relief. Methods: Patients with chronic trunk and/or leg pain who had a successful trial screening were enrolled in the 12-week IRB-approved study during which they experienced position-adaptive stimulation or conventional stimulation each for 6 weeks. Patients then rated pain relief and convenience separately on 5-point Likert scales. Results: A total of 79 patients were enrolled at 10 study centers in the US. Seventy-six patients were implanted with a RestoreSensor neurostimulator. Of the 74 patients included in an intent-to-treat analysis, 63 (85.1%) reported that position-adaptive stimulation provided better pain relief: 40 (54.1%) reported much better pain relief and 23 (31.1%) reported somewhat better pain relief, compared to conventional stimulation. Conclusions: Use of the position-adaptive stimulation feature resulted in improved pain relief for most patients when compared with conventional stimulation. The results also correlate with previously reported improvements in convenience, supporting the use of the new therapy feature in the management of chronic pain.

Funding: The RestoreSensor study was supported by Medtronic Neuromodulation.