High Frequency PNS Stimulation Study for Back and Leg Pain

Inclusion criteria * Subject is ≥ 18 years of age at time of informed consent; * Subjects have been diagnosed with predominant, chronic, intractable back pain with a VAS \> 50 mm (on a 100-mm scale); * Subjects have been diagnosed with predominant, chronic, intractable back pain for at least 6 months before study participation; * Based on the medical opinion of the Principal Investigator, subject has a stable pain medication regiment; * Based on the medical opinion of the Principal Investigator, there is no evidence of anatomic abnormalities that could jeopardize the placement of the device or pose a hazard to the subject; * Subject is willing to undergo surgical implant procedure, attend visits as scheduled, and comply with the study requirements; * Subject is willing and able to operate the patient programmer, recharging equipment and has the ability to undergo study assessments and provide accurate responses; * Based on the opinion of the implanter, subject is a good surgical candidate for the implant procedure; * Subject is male or non-pregnant female; * Subject is deemed to be neuro-psycho-socially appropriate for implantation therapies based of the assessment of a clinical psychologist and principal investigator, using face-to-face encounters and the psychological testing described in the measures; * Patient is capable of giving informed consent. Exclusion criteria * Obvious mechanical instability related to pain (diagnosed by imaging taken within the past 6 months);…