The objective of this study is to assess the effect Spinal Cord Stimulators have toward improving vascular changes of diabetes mellitus in patients eligible for SCS placement based on their condition of painful diabetic neuropathy; we will evaluate improving their disability and quality of life, improving micro-circulatory changes induced by Diabetes Mellitus (DM), improving macro-circulatory changes induced by DM and improving arterial stiffness of the vessels of the lower extremity.
Patients with DM type 2 of more than 1-year duration
DM stage 3 or less
Patients ≥18 years of age
Refractory painful diabetic peripheral neuropathy of the lower extremities
Patients on anticoagulants
Patients with active infections
Patients with HbA1>10
Psychiatric disorders and cognitive dysfunctions
Patients that have been seen in the diabetic foot clinic will be evaluated for participation in the study once they have been referred to one of our pain clinics. The study will focus on enrolling patients in early stages of DM 2 with no neuropathic ulcers or arterial calcification.
Case-only
Prospective
Not listed
Improve vascular changes
Improve vascular changes (macroscopic: color, edema, ulceration, etc)
Vascular improvement on lower extremities with the Ankle Brachial Index (ABI)
Collect data on possible macrovascular improvement in lower extremities by performing the ABI test
Vascular improvement on lower extremities with the Toe Brachial Index (TBI)
Collect data on possible macrovascular improvement in lower extremities by performing the TBI test
Vascular improvement on lower extremities with the Doppler Flowmetry
Collect data on possible macrovascular improvement in lower extremities by performing the Doppler Flowmetry
Show Improvement in pain in patients with painful diabetic neuropathy
Improve pain in patients with painful diabetic neuropathy by using the Numeric Rating Scale (NRS) that ranges from 0-10 on the pain scale.
Patients' Global Impression of Change (PGIC)
Patient satisfaction using PGIC from baseline to 6 weeks
Health-related quality of life (H-RQol)
Quality of life from baseline to 6 weeks
Oswestry Low Back Pain Disability Questionnaire (ODI)
Functional capacity using the ODI from baseline to 6 weeks
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