Table 3 Exclusion criteria

To participate in the study, subjects must not meet any of the following exclusion criteria:

 1. Have a diagnosis of a lower limb mononeuropathy (e.g., causalgia and tibial or peroneal neuropathies), have had a lower limb amputation other than toes because of diabetes, or have large (≥3 cm) or gangrenous ulcers (or both) of the lower limbs.

 2. Have an average pain intensity of at least 3 out of 10 cm on the visual analog scale in the upper extremities because of diabetic neuropathy at enrollment.

 3. Currently have a hemoglobin A1c (HbA_1c) of more than 10%.

 4. Have a body mass index of more than 45.

 5. Currently prescribed a daily opioid dosage of more than 120 mg morphine equivalents.

 6. Have a medical condition or pain in other area(s), not intended to be treated in this study, that could interfere with study procedures, accurate pain reporting, and/or confound evaluation of study endpoints, as determined by the investigator (such as primary headache, fibromyalgia, post-herpetic neuralgia, osteoarthritis, peripheral vascular disease, or small vessel disease).

 7. Have a current diagnosis of a progressive neurological disease such as multiple sclerosis, chronic inflammatory demyelinating polyneuropathy, rapidly progressive arachnoiditis, brain or spinal cord tumor, central deafferentation syndrome, complex regional pain syndrome, acute herniating disc, severe spinal stenosis, and brachial plexus injury, as determined by the investigator.

 8. Have a current diagnosis or condition such as a coagulation disorder, bleeding diathesis, platelet dysfunction, low platelet count, severely diminished functional capacity due to underlying cardiac/pulmonary disease, symptomatic uncontrolled hypertension, progressive peripheral vascular disease, or uncontrolled diabetes mellitus that presents excess risk for performing the procedure, as determined clinically by the investigator.

 9. Have experience with spinal cord stimulation, dorsal root ganglion stimulation, peripheral nerve field stimulation, or peripheral nerve stimulation for chronic intractable pain.

 10. Have significant spinal stenosis, objective evidence of epidural scarring and/or any signs or symptoms of myelopathy as determined by the investigator on the basis of magnetic resonance imaging (MRI) conducted within the past 12 months.

 11. Any history of surgery on the posterior elements (laminectomy, posterior fusion), resulting in a compromised epidural space, as determined by the investigator.

 12. Be benefitting from an interventional procedure or surgery (or both) to treat lower limb pain. (Subjects should be enrolled at least 30 days from last benefit.)

 13. Have an existing drug pump or another active implantable device such as a pacemaker or both.

 14. Have a condition currently requiring or likely to require the use of diathermy or MRI that is inconsistent with Senza system guidelines in the Physician’s Manual.

 15. Have either a metastatic malignant neoplasm or untreated local malignant neoplasm.

 16. Have a life expectancy of less than 1 year.

 17. Have a local infection at the anticipated surgical entry site or an active systemic infection.

 18. Be pregnant or plan to become pregnant during the study. Women of childbearing potential who are sexually active must use a reliable form of birth control, be surgically sterile, or be at least 2 years post-menopausal.

 19. Have within 6 months of enrollment a significant untreated addiction to dependency-producing medications, alcohol, or illicit drugs.

 20. Be concomitantly participating in another clinical study.

 21. Be involved in an injury claim under current litigation.

 22. Be a recipient of temporary Social Security Disability Insurance benefits because of chronic pain.

 23. Have a pending or approved worker’s compensation claim.

 24. Have evidence of an active disruptive psychological or psychiatric disorder or other known condition significant enough to impact perception of pain, compliance with intervention and/or ability to evaluate treatment outcome, as determined by a psychologist in the last 12 months.