Long-Term Evaluation of Spinal Cord Stimulation in Patients With Painful Diabetic Polyneuropathy: An Eight-to-Ten–Year Prospective Cohort Study

Abstract

ObjectiveThis study aimed to evaluate the long-term effects of spinal cord stimulation (SCS) in patients with painful diabetic polyneuropathy (PDPN). Materials and MethodsThis prospective cohort study was the eight-to-ten–year follow-up of a previously performed pilot and randomized controlled trial on the effects of SCS in PDPN, initiated by the multidisciplinary pain center of Maastricht University Medical Center+. The study population consisted of a subgroup of patients who still used SCS treatment ≥ eight years after implantation (n = 19). Pain intensity scores (numeric rating scale [NRS]) during the day and night and data on secondary outcomes (ie, quality of life, depression, sleep quality) were reported during yearly follow-up consultations. Long-term efficacy of SCS was analyzed by comparing the most recently obtained data eight to ten years after implantation with those obtained at baseline. ResultsPain intensity, day and night, was significantly (p < 0.01) reduced by 2.3 (NRS 6.6–4.3) and 2.2 (NRS 6.8–4.6) points, respectively, when comparing the long-term data with baseline. Moreover, for > 50% of patients, the pain reduction was > 30%, which is considered clinically meaningful. No differences were found regarding the secondary outcomes. ConclusionThis eight-to-ten–year follow-up study indicates that SCS can remain an effective treatment in the long term to reduce pain intensity in a subcohort of patients with PDPN who still had an SCS device implanted after eight years.