StimRouter Neuromodulation System includes an implanted lead which provides peripheral nerve stimulation for chronic pain. Post-stroke shoulder pain patients will be the focus of this study. After meeting inclusion/exclusion criteria, approximately 50 enrolled patients will participate in the study through 6 months of follow-up. Various measures will be used to assess patient response to use of the device.
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)
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.
- StimRouter Neuromodulation System Device
Other Names: StimRouter Intervention Desc: The StimRouter Neuromodulation System is indicated for pain management in adults who have severe intractable chronic pain of peripheral nerve origin, as an adjunct to other modes of therapy (e.g., medications). The StimRouter is not intended to treat pain in the craniofacial region. ARM 1: Kind: Experimental Label: StimRouter Neuromodulation System Description: All eligible patients who are enrolled in this study will be treated with StimRouter stimulation therapy as part of standard of care for the entire duration of the study (6 months) and observed for post-market population-specific data. Standard recommended stimulation parameters for post-stroke shoulder pain include settings to elicit sensory response (paresthesia) as well as motor response (muscle contraction).
|Type||Measure||Time Frame||Safety Issue|
|Primary||Brief Pain Inventory (BPI) Change||Change from Baseline at Month 3|
|Secondary||Patient Global Impression of Change (PGIC) Change||Change from Baseline at Month 3|
|Secondary||Patient Satisfaction||Month 3|
|Secondary||Standardized Shoulder Questionnaire (Shoulder Q) Change||Change from Baseline at Month 3|
- Bioness Inc Lead