StimRouter™ for Pain Management in Post-stroke Shoulder Pain

Adults age 18 or over with severe intractable chronic shoulder pain subsequent to stroke will be included. Pain relief will be measured after using StimRouter stimulation therapy targeting the axillary nerve. Existing/pre-study pain medications must be either maintained, reduced throughout the trial. Study Design is prospective, multi-center and will include 50 subjects The primary endpoint will be a clinically relevant pain reduction (30%) in pain score at 3 months after initiating stimulation in at least 50% of patients with no increase in pain medication. Primary Outcomes: Reduction of average pain at rest measured by numeric scale (BPI-SF5) Secondary Outcomes 1. Change in Worst Pain (BPI-SF3) 2. Least Pain \& Pain Right Now (BPI - SF 4,6) 3. Patient Global Impression of Change (PGIC) 4. Patient Satisfaction questionnaire 5. Shoulder Q Data Collection Points 1\) Baseline 2) Month 1 post-programming 3) Month 2 post-programming 4) Month 3 post-programming 5) Month 6 post-programming Data Analysis Analyses will be made to evaluate differences in outcomes compared to baseline measures, with primary endpoint at Month 3 * Standard statistical estimation and inference will be undertaken for the observed treatment effect. * All adverse events will be tabulated by their frequencies and proportions.