StimRouter™ for Pain Management in Post-stroke Shoulder Pain

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 as within 50cm of the iso-center or 16 cm of the MR coil as measured from the edge of the MRI coil.
• •Any metallic implant in the immediate area intended for implant (e.g. TSR)
• •Has demand-type cardiac pacemaker, defibrillator, or electrical nerve implant
• •Potential need for diathermy at the implant site
• •Potential need for therapeutic ultrasound at the implant site
• •Patients who have already been implanted with StimRouter TM prior to study enrollment
• •Presence of a documented condition or abnormality that could compromise the safety of the patient
• •Life expectancy of less than 1 year