Trialing of ISS in Patients With CRPS

Inclusion criteria

• Capable of giving written informed consent to participate in this clinical study.
• Must be 18 years old or older.
• Predominant pain in one or both of the lower limbs attributed to CRPS or causalgia that has been refractory to conservative therapy for at least 3 months.
• Average pain intensity larger or equal to 6 on the numeric pain rating scale (NPRS).
• Appropriate candidate for spinal cord stimulation as determined by the Investigator.
• Subjects must be on a stable dose of pain medication regimen for at least 1 month.
• Must be able to comply with the requirements of study visits.
• Have cognitive ability of operate the remote control and follow therapy instructions and directions by clinicians.

Exclusion criteria

• Systemic infection.
• Any other active implanted device.
• Evidence of serious neurological, psychological or psychiatric disorders.
• Previous posterior decompressive laminectomy that precludes appropriate posterior epidural placement of stimulation lead(s).
• Patient who are pregnant, breast-feeding or women of childbearing potential with positive pregnancy tests.
• Human immunodeficiency virus (HIV) infection or a clinically significant infection.
• 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.
• Uncontrolled diabetes, uncontrolled pulmonary disease, or uncontrolled hypertension.
• Patients who have evidence of major psychiatric disease, mental disorder, drug dependency, alcohol dependency, or substance abuse disorders.
• 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.
• 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.
• Concurrent participation in another clinical study.
• Involvement in an injury or disability claim under current litigation or a pending or approved workers' compensation claim.
• Escalating or changing pain condition over the last 30 days that creates difficulty of pain evaluation by the patient.