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Pain. 2014 Nov;155(11):2426-31. doi: 10.1016/j.pain.2014.08.031. Epub 2014 Aug 29.

Spinal cord stimulation in patients with painful diabetic neuropathy: a multicentre randomized clinical trial.

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Department of Neurosurgery, Medisch Spectrum Twente, Enschede, The Netherlands; Department of Clinical Neurophysiology, University of Twente, The Netherlands; Stichting Neurobionics Foundation, Enschede, The Netherlands. Electronic address:
Department of Anesthesiology, Aarhus University Hospital, Aarhus, Denmark.
Department of Anesthesiology, St Jansdal Ziekenhuis, Harderwijk, The Netherlands.
Department of Anesthesiology, St Antonius Ziekenhuis, Nieuwegein, The Netherlands.
Department of Anesthesiology, Virga Jessa Hospital, Hasselt, Belgium.
Department of Functional Neurosurgery and Stereotaxy, Heinrich-Heine University, Düsseldorf, Germany.
Department of Anesthesiology, Odense University Hospital, Odense, Denmark.
Department of Neurosurgery, Medisch Spectrum Twente, Enschede, The Netherlands; Stichting Neurobionics Foundation, Enschede, The Netherlands.


Painful diabetic neuropathy (PDN) is a peripheral neuropathic pain condition that is often difficult to relieve. Spinal cord stimulation (SCS) is a proven effective therapy for various types of mixed neuropathic conditions, yet effectiveness of SCS treatment for PDN is not well established. To our knowledge, ours is the first multicentre randomized controlled trial investigating the effectiveness of SCS in patients with PDN. Sixty patients with PDN in the lower extremities refractory to conventional medical therapy were enrolled and followed for 6 months. They were randomized 2:1 to best conventional medical practice with (SCS group) or without (control group) additional SCS therapy, and both groups were assessed at regular intervals. At each follow-up visit, the EuroQoL 5D, the short form McGill Pain Questionnaire (SF-MPQ) and a visual analogue scale (VAS, ranging 0-100) to measure pain intensity were recorded. The average VAS score for pain intensity was 73 in the SCS group and 67 in the control group at baseline. After 6 months of treatment, the average VAS score was significantly reduced to 31 in the SCS group (P<.001) and remained 67 (P=.97) in the control group. The SF-MPQ and EuroQoL 5D questionnaires also showed that patients in the SCS group, unlike those in the control group, experienced reduced pain and improved health and quality of life after 6 months of treatment. In patients with refractory painful diabetic neuropathy, spinal cord stimulation therapy significantly reduced pain and improved quality of life.


Diabetes mellitus; Diabetic peripheral polyneuropathy; Neuromodulation; Neuropathic pain; Randomized controlled trial; Spinal cord stimulation

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