Comparison of 10 kHz SCS Combined With CMM to CMM Alone in the Treatment of Neuropathic Limb Pain

Inclusion Criteria:

1. Have been clinically diagnosed with painful diabetic neuropathy (PDN) of the lower
limbs.

2. Average pain intensity of ≥ 5 out of 10 cm on the VAS in the lower extremities at
enrollment.

3. Have stable neurological status.

4. Be on a stable analgesic regimen.

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.

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 capable of giving informed consent.

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

Exclusion Criteria:

1. Have a diagnosis of a lower limb mononeuropathy, have had a lower limb amputation, or
have large (≥3 cm) and/or gangrenous ulcers of the lower limbs.

2. Have a BMI ≥ 40.

3. Currently prescribed a daily opioid dosage > 120 mg morphine equivalents.

4. Have a medical condition or pain in other area(s), not intended to be treated in this
study.

5. Have a current diagnosis of a progressive neurological disease such a 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.

6. 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.

7. Have failed prior SCS, dorsal root ganglion (DRG) stimulation, or peripheral nerve
stimulation (PNS) trials for chronic intractable pain.

8. Have significant spinal stenosis, objective evidence of epidural scarring and/or any
signs or symptoms of myelopathy.

9. Any previous history of surgery on the posterior elements (laminectomy, posterior
fusion) resulting in a compromised epidural space.

10. Be benefitting from an interventional procedure and/or surgery to treat lower limb
pain.

11. Have an existing drug pump and/or another active implantable device such as a
pacemaker.

12. 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.

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

14. Have a life expectancy of less than one year.

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

16. 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.

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

18. Be concomitantly participating in another clinical study.

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

20. Be a recipient of Social Security Disability Insurance (SSDI).

21. Have a pending or approved worker's compensation claim.

22. 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.