This Registry study will prospectively evaluate the long-term effectiveness, safety, and tolerability of the StimRouter Neuromodulation System, along with evaluating the technical performance of StimRouter, surgical outcomes, health-related quality of life, concomitant medical use, and subject's impression of improvement.
This is a prospective, open-label, long-term, multi-center registry. Up to 173 subjects with chronic pain related to peripheral nerve will be enrolled by approximately 15 qualified sites. Subjects who are eligible for a StimRouter will be enrolled in order to evaluate the subject's experience at pre-implant, the implant, and post-implant for up to 24 months. Based on routine care, subjects will be seen at day of implant, within 2 weeks post-implant, 3 months post-implant, 6 months post-implant, 9 months post implant, 12 months post-implant, and 24 month post-implant.
Study Type
OBSERVATIONAL
Enrollment
62
An implantable neuromodulation device that treats chronic peripheral nerve pain.
University of California San Diego
La Jolla, California, United States
California Orthopedics & Spine
Larkspur, California, United States
Stanford University
Redwood City, California, United States
Change in Pain from Screening through 6 Months
Change from baseline to 6 months post-permanent implant in aversge pain assessed by using a Numeric Rating Scale
Time frame: Month 6
Change in Pain Severity post-implantation
Average change from baseline to month 6 post-implantation in Pain Severity score as measured through the BPI-SF
Time frame: Month 6
Change in Pain Interference post-implantation
Average change from baseline to month 6 post-implantation in Pain Interference score as measured through the BPI-SF
Time frame: Month 6
Change in Health-related Quality of Life
Average change from baseline to month 6 in health-related quality of life as assess by the VR-12 questionnaire
Time frame: MOnth 6
Change in Patient Global Impression of change
Average change from baseline to month 6 in patient global impression of change (PGIC)
Time frame: Month 6
Patient Treatment Satisfaction
Overall patient treatment satisfaction survey
Time frame: Month 6
Pain medication use
Decrease in chronic pain related medication intake at month 6 when compared to baseline
Time frame: Month 6
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Stamford Hospital
Stamford, Connecticut, United States
International Spine,Pain and Performance Center
Washington D.C., District of Columbia, United States
Warner Orthopedics
Baton Rouge, Louisiana, United States
Albert Einstein/Moss Rehab
Elkins Park, Pennsylvania, United States
Valley Sports and Spine Clinic
Blacksburg, Virginia, United States
Advocate Aurora Health
Oshkosh, Wisconsin, United States