Trialing of ISS in Patients With CRPS

Exclusion Criteria

• •1. Systemic infection.
• •2. Any other active implanted device.
• •3. Evidence of serious neurological, psychological or psychiatric disorders.
• •4. Previous posterior decompressive laminectomy that precludes appropriate posterior epidural placement of stimulation lead(s).
• •5. Patient who are pregnant, breast-feeding or women of childbearing potential with positive pregnancy tests.
• •6. Human immunodeficiency virus (HIV) infection or a clinically significant infection.
• •7. A clinically significant disorder such as cerebrovascular disease, pulmonary infarction, ischemic heart disease, cardiac dysrhythmia, myocardial infarction, or congestive heart failure or any other as determined by the investigator.
• •8. Uncontrolled diabetes, uncontrolled pulmonary disease, or uncontrolled hypertension.
• •9. Patients who have evidence of major psychiatric disease, mental disorder, drug dependency, alcohol dependency, or substance abuse disorders.
• •10. Patients who have progressive neurological disease such as multiple sclerosis, chronic inflammatory demyelinating polyneuropathy, rapidly progressive arachnoiditis, acute herniated disc, or any other as determined by investigator.
• •11. Medical condition or pain in other body areas determined by the Investigator as interfering with study procedures, accurate pain reporting, and/or confound evaluation of study end points.
• •12. Concurrent participation in another clinical study.
• •13. Involvement in an injury or disability claim under current litigation or a pending or approved workers' compensation claim.
• •14. Escalating or changing pain condition over the last 30 days that creates difficulty of pain evaluation by the patient.