To evaluate the effects of Spinal Cord Stimulation (SCS) in treating painful Diabetic Peripheral Neuropathy (pDPN).

The efficacy of conventional medications to treat pain and other sensory deficits in painful diabetic peripheral neuropathy (pDPN) is been recognized to be limited. Further, autonomic dysfunction is a common but often underappreciated complication that can affect various vital functions such as the gastrointestinal (e.g. constipation), genitourinary (e.g. erectile dysfunction), cardiovascular (e.g. orthostatic intolerance) and sudomotor (e.g. sweat gland activity). 

Patients with classical “stocking-and-glove” pDPN pain affecting their lower (primarily) and upper limbs are being treated with Spinal Cord Stimulation (SCS): 4-port system and percutaneous leads at thoracic (T10-T12) and cervical (C5-T1) levels. Assessment as performed pre- and post-SCS implantation (3-, 6- and 12-months), including: i) standard questionnaires related to pain (VAS,NPSI), quality-of-life, sleep and autonomic impairment (BASQ); and ii) objective tests examining neurological function: EMG, nerve conduction studies (NCS), neurological exam (UENS), hands and feet skin conductance and thermography, and small-fiber density quantification.

To date, 11 pDPN subjects have been implanted. At last follow-up (N=8,~8months), patients reported significant relief in: i) pain (VAS from 8.6-to-1.7 in lower-limbs and from 6.2-to-1.1 in upper-limbs, p<0.05); ii) neuropathic symptoms (NPSI from 43-to-8, p<0.05); and iii) autonomic symptoms at multiple functions such as orthostatic, genital/sexual or pupillomotor (BASQ from 27.9-to-16.7; p=0.018). In addition, we observed a progressive neurological recovery in both large- and small-fibers function based on: i) improved exam (UENS from 21-to-13; p=0.027); ii) less severe EMG and largely improved sensory NCS; iii) improved sudomotor function based on feet temperature decrease (from 30.8º-to-26.7º; p=0.04) and increased soles conductance (from 38-to-46 uS).

Our current data indicate that SCS can effectively treat pDPN by eliciting relief of pain, sensory and autonomic symptoms, and restoring large- and small-nerve function.