StimRouter™ for Pain Management in Post-stroke Shoulder Pain (NCT03093935) | Clinical Trial Compass
TerminatedNot Applicable
StimRouter™ for Pain Management in Post-stroke Shoulder Pain
Stopped: Lack of subject participation
United States6 participantsStarted 2018-07-01
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Male or female age ≥18 years and confirmed diagnosis of stroke
* Competent to provide consent and comply with study requirements
* Minimum 3 months of severe chronic focal post-stroke shoulder pain
* Stable regimen of pain medications for \>4 weeks prior to implant and willing to maintain equivalent dosage throughout the study
* A mean score of \> 4 on the Brief Pain Inventory short form, question 3 (BPI-SF3)
* Capable and willing to follow all study-related procedures
* Able to tolerate surface stimulation as demonstrated by motor level response at shoulder
Exclusion Criteria:
* Patients who decline to provide written consent or to attend follow-up visits
* Shoulder pathology (e.g. rotator cuff tear, frozen shoulder etc) at target limb
* Evidence of a primary central or regional pain pattern inclusive of shoulder
* Diagnosed/confirmed shoulder dysfunction
* Botox or other neurolytic agent injections in last 3 months
* Any confounding neurologic conditions affecting the upper limb
* Evidence or history of skin infections
* History of adverse reactions to local anesthetics (e.g. lidocaine) or adhesives
* Patients who have an active systemic infection or are immunocompromised
* Patients who are pregnant, intend to become pregnant, are breastfeeding or of child-bearing potential and not practicing a medically-approved method of birth control
* Currently requiring or likely to require Magnetic Resonance Imaging (MRI) within the MRI exclusion zone defined …