Sponsor study identifier
interventional
6
1 country
2
Study Start
July 1, 2018
Actual (reported)Primary Completion
November 20, 2020
Actual (reported)Study Completion
November 20, 2020
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 20, 2020
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 18, 2017
Actual (reported)March 28, 2017
Actual (reported)July 1, 2018
Actual (reported)November 20, 2020
Actual (reported)November 20, 2020
Actual (reported)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.
Change from Baseline at Month 3
Patient Global Impression of Change (PGIC) Change
Change from Baseline at Month 3
Patient Satisfaction
Month 3
Standardized Shoulder Questionnaire (Shoulder Q) Change
Change from Baseline at Month 3
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).
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
University of Miami
Miami, Florida, 33136, United States
University of Utah
Salt Lake City, Utah, 84123, United States
Keith McBride
Bioness Inc
6 participants (actual enrollment reported by the registry).
First Submitted
March 18, 2017
First Posted
March 28, 2017
Study Start
July 1, 2018
Actual (reported)EMPOWER: Randomized Trial of Online Chronic Pain Management Program to Reduce Reliance on Opioid Analgesic Medications
Contact the study team to confirm eligibility.
Primary Completion
November 20, 2020
Actual (reported)Study Completion
November 20, 2020
Actual (reported)Last Updated
January 6, 2021
Record last verified: 2020-12
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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