Spinal Cord Stimulation and Pain Relief in Painful Diabetic Peripheral Neuropathy: A Prospective Two-Center Randomized Controlled Trial

• DOI: 10.2337/dc14-0684
• Publication Date: 2014-09-12T06:58:44Z
• Authors: Rachel Slangen; Nicolaas C. Schaper; Catharina G. Faber; Elbert A. Joosten; Carmen D. Dirksen; Robert T. van Dongen; Alfons G. Kessels; Maarten van Kleef
• Keywords: Radboudumc 18: Healthcare improvement science RIHS: Radboud Institute for Health Sciences; INVOLVEMENT; Adult; Male; CLINICAL IMPORTANCE; RECOMMENDATIONS; VALIDATION; 03 medical and health sciences; 0302 clinical medicine; Diabetic Neuropathies; QUALITY-OF-LIFE; Humans; Pain Management; Prospective Studies; POPULATION; Aged; Spinal Cord Stimulation; Middle Aged; PREVALENCE; 3. Good health; HEALTH UTILITIES; COMMUNITY; Treatment Outcome; Lower Extremity; POLYNEUROPATHY; Female

OBJECTIVE Painful diabetic peripheral neuropathy (PDPN) is a common complication of diabetes mellitus. Unfortunately, pharmacological treatment often partially effective or accompanied by unacceptable side effects, and new treatments are urgently needed. Small observational studies suggested that spinal cord stimulation (SCS) may have positive effects. RESEARCH DESIGN AND METHODS We performed multicenter randomized clinical trial in 36 PDPN patients with severe lower limb pain not responding to conventional therapy. Twenty-two were randomly assigned SCS combination the best medical (BMT) (SCS group) 14 BMT only (BMT group). The system was implanted if successful. Treatment success defined as ≥50% relief during daytime nighttime “(very) much improved” for sleep on patient global impression change (PGIC) scale at 6 months. RESULTS Trial successful 77% patients. observed 59% 7% (P < 0.01). Pain reported 41 36% group 0 group, respectively 0.05). 55 whereas no changes seen 0.001 P One died because subdural hematoma. CONCLUSIONS shown who treated over 6-month period, although this without risks.