Pain and Neurological Function Improvements With 10 kHz Spinal Cord Stimulation Treatment of Painful Diabetic Neuropathy

Inclusion criteria

• Has been clinically diagnosed with diabetes, according to the American Diabetes Association guidelines, as well as painful diabetic neuropathy (PDN) of the lower limbs.
• Has pain intensity (over the last 7 days) of ≥5 out of 10 cm on the Visual Analog Scale (VAS) in the lower limbs at both the Enrollment and Baseline Visits.
• Has PDN symptoms that have been present ≥12 months.
• Is currently taking or has tried in the past a gabapentinoid and at least one other class of analgesic with insufficient pain relief or intolerable side effects.
• Has been 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.
• Has painful diabetic sensorimotor polyneuropathy confirmed by modified Toronto Clinical Neuropathy Score (mTCNS) >5 at enrollment. The total score must include presence of foot pain (≥1) and sensory exam findings (≥ 2).
• Has hemoglobin A1c ≤10% as measured at enrollment.
• Is 22 years of age or older at the time of enrollment.
• Is an appropriate candidate for the surgical procedures required in this study based on the clinical judgment of the study physician.
• Is willing to and capable of giving written informed consent.
• Is willing and able to comply with study-related requirements and procedures and attend all scheduled visits.

Exclusion criteria

• Has a diagnosis of a lower limb mononeuropathy (e.g., causalgia, tibial or peroneal neuropathies), has had a lower limb amputation other than toes due to diabetes, or has large (≥3 cm) and/or gangrenous ulcers or active infection of the lower limbs.
• Has an average pain intensity of ≥ 3 out of 10 cm on the VAS in the upper limbs due to diabetic neuropathy at enrollment.
• Has a history of glycemia-related hospitalizations or emergency ward visits including ketoacidosis, hyperosmolar state, severe hypoglycemia in the previous 6 months.
• Uses anticoagulants or antiplatelet agents that cannot be temporarily discontinued prior to the procedure.
• Has unstable cardiovascular disease, including untreated cardiac arrhythmias, myocardial infarction within last 12 months, New York Heart Association (NYHA) Functional Class III or IV heart failure.
• Is currently prescribed a daily opioid dosage > 120 mg morphine equivalents.
• Has a medical condition or diagnosis that is inconsistent with the Senza System guidelines in the Physician's Manual or as per standard clinical practice.
• Has 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, critical limb ischemia due to peripheral vascular disease or small vessel disease).
• Has prior experience with SCS, dorsal root ganglion (DRG) stimulation, peripheral nerve field stimulation (PNfS), or peripheral nerve stimulation (PNS) for chronic intractable pain.
• Has an existing drug pump and/or another active implantable device such as a pacemaker (ok to have an insulin pump or continuous glucose monitor that remains externalized).
• Has 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.
• Has a life expectancy of less than one year.
• Has a local infection at the anticipated surgical entry site or an active systemic infection.
• Is pregnant or plans to become pregnant during the study (participants of child-bearing potential that are sexually active must use a reliable form of birth control).
• Has had within 6 months of enrollment a significant untreated addiction to dependency producing medications, alcohol or illicit drugs.
• Is concomitantly participating in another interventional clinical study.
• Is involved in an injury claim for study-related chronic pain that is under current litigation.
• Is a recipient of temporary Social Security Disability Insurance (SSDI) benefits due to study-related chronic pain.
• Has a pending or approved worker's compensation claim for study-related chronic pain.
• Has 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 the investigator in the last 12 months.
• Has a BMI > 45 at enrollment.