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)