SCS for the Treatment Of Chronic Pain of the Upper Extremities

Key Inclusion Criteria:

• Have been diagnosed with chronic, intractable pain of an upper extremity of neuropathic origin, which has been refractory to conservative therapy for a minimum of 3 months.
• Have an average pain intensity (over a period of 7 days) of an upper extremity of ≥ 5 out of 10 cm on the Visual Analog Scale (VAS) at enrollment.
• Be on stable pain medications for at least 28 days and be willing to stay on those medications with no dose adjustments until activation of the permanently implanted SCS device.
• Be 18 years of age or older at the time of enrollment.
• Be an appropriate candidate for the surgical procedures required in this study.
• Be capable of subjective evaluation, able to read and understand English-written questionnaires, and are able to read, understand and sign the written inform consent in English.
• Have stable neurological status measured by motor, sensory and reflex function.

Key Exclusion Criteria:

• Have a medical condition or pain in other area(s), not intended to be treated with SCS, that could interfere with study procedures.
• Have a current diagnosis of a progressive neurological disease.
• Have a current diagnosis or condition such as a coagulation disorder, bleeding diathesis, platelet dysfunction, progressive peripheral vascular disease or uncontrolled diabetes mellitus that presents excess risk for performing the procedure.
• Have mechanical spine instability as determined.
• Have significant stenosis, based on MRI.
• Have an existing drug pump and/or another active implantable device (switched on or off) such as a pacemaker or other SCS devices.
• Have a condition currently requiring or likely to require the use of whole body MRI or diathermy.
• Be pregnant (if female and sexually active, subject must be using a reliable form of birth control, be surgically sterile or be at least 2 years post-menopausal).
• Have within 6 months of enrollment a significant untreated addiction to dependency producing medications, alcohol or illicit drugs.
• Be involved in an injury claim under current litigation.
• Have a pending or approved worker's compensation claim.
• Have evidence of an active disruptive psychological or psychiatric disorder or other known condition significant enough to impact perception of pain, compliance of intervention and/or ability to evaluate treatment outcome, as determined by a psychologist.