An interventional study of StimRouter Neuromodulation System in Chronic Pain and Hemiplegic Shoulder Pain, sponsored by Bioness Inc. Terminated at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-01-06.
Sponsored by Bioness Inc · Not applicable, Interventional, and Treatment
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)
Secondary Outcomes
707 studies on the registry are indexed under Shoulder Pain; 152 are open to participants now.
This study's enrollment of 6 is below the median of 60 across 561 interventional studies indexed under Shoulder Pain.
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Exclusion Criteria:
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).
Device: StimRouter Neuromodulation System
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.
Also known as: StimRouter
Brief Pain Inventory (BPI) Change
The Brief Pain Inventory (BPI) form is a standard pain assessment tool based on a 0 to 10 scale. The Average Pain at Rest (BPI question number 5) score will be assessed at Baseline and approximately 3 months after programming (therapy start) to determine if there is a significant reduction in average pain with the addition of StimRouter TM treatment to standard of care.
Time frame: Change from Baseline at Month 3
Patient Global Impression of Change (PGIC) Change
Patient Global Impression of Change (PGIC) survey assesses perceived overall change in a combination of pain and life quality
Time frame: Change from Baseline at Month 3
Patient Satisfaction
Patient Satisfaction will be measured by a numeric (i.e., 1-5) rating scale (NRS)
Time frame: Month 3
Standardized Shoulder Questionnaire (Shoulder Q) Change
Change in difficulty level (on a scale from 0 to 3) or ability (yes/no) for completing normal day-to-day activities such as combing hair or lifting an 8 pound container to the shoulder level without bending the elbow, as measured by the Shoulder Q standardized questionnaire.
Time frame: Change from Baseline at Month 3
Plan to share: No
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This study is terminated, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.
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Bioness Inc