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Diabetes Care. 2018 Jan;41(1):32-38. doi: 10.2337/dc17-0983. Epub 2017 Nov 6.

Severity of Neuropathy Is Associated With Long-term Spinal Cord Stimulation Outcome in Painful Diabetic Peripheral Neuropathy: Five-Year Follow-up of a Prospective Two-Center Clinical Trial.

Author information

1
Department of Anesthesiology and Pain Medicine, Maastricht University Medical Centre, Maastricht, the Netherlands m.vanbeek@maastrichtuniversity.nl maarten.van.kleef@mumc.nl.
2
Department of Anesthesiology and Pain Medicine, Maastricht University Medical Centre, Maastricht, the Netherlands.
3
Department of Anesthesiology, Rijnstate Hospital, Arnhem, the Netherlands.
4
Department of Internal Medicine, Maastricht University Medical Centre, Maastricht, the Netherlands.
5
Department of Neurology, Maastricht University Medical Centre, Maastricht, the Netherlands.
6
Department of Clinical Epidemiology and Medical Technology Assessment, Maastricht University Medical Centre+, Maastricht, the Netherlands.
7
Care and Public Health Research Institute School for Public Health and Primary Care, Maastricht University, Maastricht, the Netherlands.
8
Department of Anesthesiology, Pain, and Palliative Care, Radboud University Medical Centre, Nijmegen, the Netherlands.

Abstract

OBJECTIVE:

Evidence from prospective studies for long-term treatment efficacy of spinal cord stimulation (SCS) in painful diabetic peripheral neuropathy (PDPN) is not available. We report prospective data on the effect of SCS on pain ratings, treatment success and failure, and complications during a 5-year follow-up in patients with PDPN.

RESEARCH DESIGN AND METHODS:

Patients with PDPN (n = 48) were included in this prospective multicenter study. The Michigan Diabetic Neuropathy Score (MDNS) was used to assess the severity of neuropathy. Numerical rating scale (NRS) score for pain, Patient's Global Impression of Change (PGIC), and treatment success (50% reduction of NRS score or significant PGIC) during 5 years of follow-up were evaluated. Complications of SCS were reported, and associations between baseline characteristics and SCS trial success or failure during a 5-year follow-up were investigated by using survival analyses.

RESULTS:

Treatment success was observed in 55% of patients after 5 years. Median duration of SCS treatment was 60 months (minimum 1 month, maximum 60 months), and 80% of patients with a permanent implant still used their SCS device after 5 years. Higher MDNS was associated with treatment failure during the 5-year follow-up (hazard ratio 3.9 [95% CI 1.3-11.6]; P = 0.014).

CONCLUSIONS:

SCS is successful in reducing chronic pain symptoms in the lower extremities of patients with PDPN up to 5 years after initiation of treatment. Furthermore, 80% of patients with PDPN still use their SCS device after 5 years. Moreover, the severity of neuropathy is associated with a higher chance of long-term treatment failure during a 5-year follow-up.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT01162993 NCT00802022.

PMID:
29109298
DOI:
10.2337/dc17-0983
[Indexed for MEDLINE]

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