Table 2 Inclusion criteria

To participate in the study, subjects must meet all of the following inclusion criteria:

 1. Have been clinically diagnosed with diabetes, in accordance with the American Diabetes Association guidelines, as well as painful diabetic neuropathy of the lower limbs, and

  a. are symptomatic despite conservative therapy for a minimum of 12 months

  b. have tried pregabalin (Lyrica®) OR gabapentin (Neurontin®, Gralise®, etc.) administered at an adequate dose and for an appropriate duration in the investigator’s judgement

  c. have tried at least one other class of analgesic medication in addition to pregabalin/gabapentin

  d. are on a stable dosage of analgesic medications for at least 30 days

 2. Average pain intensity of at least 5 out of 10 cm on the visual analog scale in the lower extremities at enrollment.

 3. Have stable neurological status measured by motor, sensory, and reflex function as determined by the investigator.

 4. Be on a stable analgesic regimen, as determined by the investigator, for at least 30 days prior to assessing pain intensity as described in inclusion criterion #2 and be willing to stay on those medications with no dose adjustments until activation of the permanently implanted spinal cord stimulation (SCS) device (10-kHz SCS therapy group) or baseline assessment (conventional medical management–only group).

 5. Be 22 years of age or older at the time of enrollment.

 6. Be an appropriate candidate for the surgical procedures required in this study on the basis of the clinical judgment of the implanting physician.

 7. Be capable of subjective evaluation; able to read and understand English-written questionnaires; and able to read, understand, and sign the written informed consent in English.

 8. Be willing and able to give informed consent.

 9. Be willing and able to comply with study-related requirements, procedures, and scheduled visits.

 10. Have adequate cognitive ability to use a patient programmer and recharger as determined by the investigator.