Table 1.

Inclusion/exclusion criteria

Inclusion criteria

• Ability to provide informed consent • Aged 22 years or older • Chronic intractable neuropathic pain of the trunk and/or limbs • Baseline average daily overall pain score of ≥60 on the Visual Analog Scale collected with the 7-day Pain Diary • Failed ≥3 documented medically supervised treatments (including, but not limited to, physical therapy, acupuncture, etc.) as well as treatment with ≥2 classes of medication • Stable pain-related medication regimen 4 weeks prior to the screening evaluation • Deemed a good candidate for SCS by the investigator • Deemed a suitable study candidate by a psychologist or psychiatrist • Agrees not to add to or increase pain medication during the study • Willing to cooperate with the study requirements, including compliance with the regimen and completion of all office visits • Female candidates of child-bearing potential agree to commit to the use of an effective method of contraception for the duration of the study

Exclusion criteria

• Current participation in a clinical trial with an active treatment arm • History of a neurostimulation trial or implanted system • Presence of an infusion pump or any implantable neurostimulator • Overall Beck Depression Inventory II score is >24 or, at the screening visit, a score of 3 on Question 9 relating to suicidal thoughts or wishes • Receiving, applying for, or considering workers’ compensation or involved in disability litigation • Concurrent clinically significant or disabling chronic pain problem that requires additional treatment • Existing medical condition that is likely to require repetitive MRI evaluation • Existing medical condition that is likely to require the use of diathermy • History of cancer requiring active treatment in the past 6 months • Pain originating from peripheral vascular disease • Participant is immunocompromised • Documented history of allergic response to titanium or silicone • Documented history of substance (narcotics, alcohol, etc.) abuse or dependency in the 6 months prior to baseline • Pregnancy (confirmed by positive urine/blood test)

MRI magnetic resonance imaging, SCS spinal cord stimulation