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

Rachel Slangen; Nicolaas C. Schaper; Catharina G. Faber; Elbert A. Joosten; Carmen D. Dirksen; Robert T. van Dongen; Alfons G. Kessels; Maarten van Kleef

doi:10.2337/dc14-0684

journal article Oct 10, 2014

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

Rachel Slangen Nicolaas C. Schaper

Catharina G. Faber

Elbert A. Joosten Carmen D. Dirksen Robert T. van Dongen Alfons G. Kessels Maarten van Kleef

Diabetes Care Vol. 37 No. 11 pp. 3016-3024 · American Diabetes Association

View at Publisher Save 10.2337/dc14-0684

Abstract

OBJECTIVE
Painful diabetic peripheral neuropathy (PDPN) is a common complication of diabetes mellitus. Unfortunately, pharmacological treatment is 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 a multicenter randomized clinical trial in 36 PDPN patients with severe lower limb pain not responding to conventional therapy. Twenty-two patients were randomly assigned to SCS in combination with the best medical treatment (BMT) (SCS group) and 14 to BMT only (BMT group). The SCS system was implanted only if trial stimulation was successful. Treatment success was defined as ≥50% pain relief during daytime or nighttime or “(very) much improved” for pain and sleep on the patient global impression of change (PGIC) scale at 6 months.

RESULTS
Trial stimulation was successful in 77% of the SCS patients. Treatment success was observed in 59% of the SCS and in 7% of the BMT patients (P &lt; 0.01). Pain relief during daytime and during nighttime was reported by 41 and 36% in the SCS group and 0 and 7% in the BMT group, respectively (P &lt; 0.05). Pain and sleep were “(very) much improved” in 55 and 36% in the SCS group, whereas no changes were seen in the BMT group, respectively (P &lt; 0.001 and P &lt; 0.05). One SCS patient died because of a subdural hematoma.

CONCLUSIONS
Treatment success was shown in 59% of patients with PDPN who were treated with SCS over a 6-month period, although this treatment is not without risks.

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References

Details

Published: Oct 10, 2014
Vol/Issue: 37(11)
Pages: 3016-3024

Authors

R

Rachel Slangen

Department of Anesthesiology and Pain Medicine, Maastricht University Medical Centre, Maastricht, the Netherlands

N

Nicolaas C. Schaper

Department of Internal Medicine, Maastricht University Medical Centre, Maastricht, the Netherlands

C

Catharina G. Faber

Department of Neurology, Maastricht University Medical Centre, Maastricht, the Netherlands

E

Elbert A. Joosten

Department of Anesthesiology and Pain Medicine, Maastricht University Medical Centre, Maastricht, the Netherlands

C

Carmen D. Dirksen

Department of Clinical Epidemiology and Medical Technology Assessment, Maastricht University Medical Centre, Maastricht, the Netherlands; CAPHRI School of Public Health and Primary Care, Maastricht University, Maastricht, the Netherlands

R

Robert T. van Dongen

Department of Anesthesiology, Pain, and Palliative Care, Radboud University Medical Centre, Nijmegen, the Netherlands

A

Alfons G. Kessels

Department of Clinical Epidemiology and Medical Technology Assessment, Maastricht University Medical Centre, Maastricht, the Netherlands

M

Maarten van Kleef

Department of Anesthesiology and Pain Medicine, Maastricht University Medical Centre, Maastricht, the Netherlands; Department of Anesthesiology, Free University of Amsterdam, Amsterdam, the Netherlands

Cite This Article

Rachel Slangen, Nicolaas C. Schaper, Catharina G. Faber, et al. (2014). Spinal Cord Stimulation and Pain Relief in Painful Diabetic Peripheral Neuropathy: A Prospective Two-Center Randomized Controlled Trial. Diabetes Care, 37(11), 3016-3024. https://doi.org/10.2337/dc14-0684

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

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