Position-Adaptive Stimulation and Improved Pain Relief: Results of the RestoreSensor Study Lynn Webster, MD Lifetree Clinical Research and Pain Clinic,

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Presentation transcript:

Position-Adaptive Stimulation and Improved Pain Relief: Results of the RestoreSensor Study Lynn Webster, MD Lifetree Clinical Research and Pain Clinic, Salt Lake City, UT David Schultz, MD MAPS Applied Research Center, Edina, MN Mark Sun, PhD Medtronic, Inc., Minneapolis, MN Ye Tan, MS Version 2.0, 30 Nov 2012

Presenter Disclosure Information Employee at Medtronic, Inc. RestoreSensor clinical study manager Version 2.0, 30 Nov 2012

Background For many patients, the intensity of spinal cord stimulation changes with body position1-3 Position-related changes in stimulation intensity may limit therapy efficacy and patient satisfaction4 A position-adaptive stimulation feature was developed to address these challenges Olin JC, Kidd DH, North RB. Postural changes in spinal cord perceptual thresholds. Neuromodulation. 1998;1:171–175. Cameron T, Aló KM. Effects of posture on stimulation parameters in spinal cord stimulation. Neuromodulation. 1998;1:177–183. 3. Abejón D, Feler C. Is impedance a parameter to be taken into account in spinal cord stimulation? Pain Physician. 2007;10:533–540. 4. Kuechmann C, Valine T, Wolfe D. Could automatic position-adaptive stimulation be useful in spinal cord stimulation? 2009. Poster presented at: 6th Congress of the European Federation of ISAP® Chapters (EFIC); September 9–12, 2009; Lisbon, Portugal. Version 2.0, 30 Nov 2012

Background RestoreSensor study demonstrated the clinical benefits of position-adaptive stimulation5 5. Schultz DM, Webster L, Kosek P, Dar U, Tan Y, Sun M. Sensor-driven position-adaptive spinal cord stimulation for chronic pain. Pain Physician. 2012;15:1-12. Version 2.0, 30 Nov 2012

Study Design Version 2.0, 30 Nov 2012

Patients Patients enrolled: N = 79 at 10 US study centers Age: 52.6 (27 - 85) years Female: 60%, N = 47 Male: 40%, N = 32 Baseline average NPRS scores: 6.1 (2.7 - 10) Version 2.0, 30 Nov 2012 6

Pain Etiologies Version 2.0, 30 Nov 2012

Dual Primary Efficacy Objective Improved pain relief with no loss of convenience and/or Improved convenience with no loss of pain relief Version 2.0, 30 Nov 2012

Assessment of Pain Relief: Primary Efficacy Objective Assessment: Two Separate 5-Point Likert Scales Assessment of Pain Relief: Assessment of Convenience: 1 2 3 4 5 Much worse Somewhat worse No difference Somewhat better Much better Much less Somewhat less No difference Somewhat more Much more Version 2.0, 30 Nov 2012

Composite Primary Efficacy Results: Improved Pain Relief and/or Convenience 86.5% p<0.001 Predefined acceptance threshold Version 2.0, 30 Nov 2012 10

Improved Pain Relief Version 2.0, 30 Nov 2012

Improved Convenience Version 2.0, 30 Nov 2012

Conclusions Position-adaptive stimulation improved pain relief and/or convenience for most patients when compared with conventional stimulation Reported improvements in pain relief and/or convenience may lead to greater overall patient satisfaction with spinal cord stimulation therapy Version 2.0, 30 Nov 2012