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

Neuromodulation. 2023 Jul;26(5):1074-1080. doi: 10.1016/j.neurom.2022.12.003. Epub 2022 Dec 31.

Abstract

Objective: This study aimed to evaluate the long-term effects of spinal cord stimulation (SCS) in patients with painful diabetic polyneuropathy (PDPN).

Materials and methods: This 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.

Results: Pain 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.

Conclusion: This 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.

Keywords: Long-term care; neuromodulation; pain management; painful diabetic neuropathy; spinal cord stimulation.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Diabetes Mellitus*
  • Diabetic Neuropathies* / therapy
  • Follow-Up Studies
  • Humans
  • Pain
  • Prospective Studies
  • Quality of Life
  • Spinal Cord
  • Spinal Cord Stimulation*
  • Treatment Outcome