Ensayos clínicos

Inclusion Criteria:

• Type 2 diabetes mellitus.
• Refractory predominantly lower extremity neuropathic pain for > 1 year.
• Presence of length dependent peripheral neuropathy on sudomotor testing (Q-SWEAT).
• Completed spinal cord stimulation trial with 40% or greater pain reduction from baseline.
• Failed medication trials or contraindication to gabapentinoid medications (gabapentin, pregabalin) and/or serotonin/norepinephrine reuptake inhibitors (tricyclic antidepressant (TCA) or duloxetine or venlafaxine).
• Average pain score on a visual analog scale (VAS) of ≥ 5 (with 0 representing no pain and 10 the worst pain imaginable).
• Appropriate surgical candidate for SCS56.

Exclusion Criteria: 

• Severe Autonomic Neuropathy as measured by the composite autonomic scoring scale (10 point scale) with a score ≥ 752.
• History of sympathectomy.
• Uncontrolled arterial hypertension (Systolic Blood Pressure >160).
• Baseline Foot TcPO2 < 10 mmHg to exclude patients with severe peripheral arterial disease.
• Hemoglobin A1c > 8%.
• Stable opioid regimen with oral morphine equivalent ≥ 100 mg/day.
• Alternative principle cause for peripheral neuropathy or lower extremity neuropathic pain.
• Disruptive psychiatric disorder (screened for during preoperative psychiatric evaluation).
• Pending litigations.
• Women of child bearing potential unwilling to use contraception or found to be pregnant as part of perioperative screening.
• Patients unable to hold medications that would impact autonomic testing.