October 28, 2014
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Spinal cord stimulation may relieve painful diabetic peripheral neuropathy

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Spinal cord stimulation could improve pain and sleep symptoms for patients with diabetes and peripheral neuropathy previously unresponsive to conventional therapy, according to research published in Diabetes Care.

Success was seen in more than half of patients with painful diabetic peripheral neuropathy (PDPN) treated with spinal cord stimulation (SCS) and best medical treatment in a study by researchers in the Netherlands, but the therapy carries risk, they said. 

“Our findings show that in PDPN patients, SCS in combination with best medical treatment results in clinically relevant pain relief over a 6-month period,” the researchers wrote.

Rachel Slangen, a PhD student at Maastricht University Medical Centre, and colleagues conducted a multicenter randomized clinical trial involving 36 patients with severe lower limb pain not responding to therapy.

The researchers assigned 22 patients to SCS in combination with best medical treatment (SCS group) and 14 to best medical treatment only (BMT group). A trial was done to determine stimulation success and target those patients to receive an implanted SCS system.

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, both at 6 months.

Trial stimulation was successful in 77% of SCS patients. Treatment success was seen in 59% of the SCS group and 7% of the BMT group (P<.01). Pain relief during daytime was reported by 41% of patients in the SCS group vs. 0% in the BMT group, whereas relief during the night was observed by 36% of patients in the SCS group vs. 7% in the BMT group (P<.05). In the SCS group, pain and sleep were “(very) much improved” in 55% and 36% of patients, but no changes were seen in the BMT group (P<.001 and P<.05, respectively).

No differences were observed in health-related quality of life with SCS. One SCS patient died due to a subdural hematoma.

“The most common complications related to SCS are hardware related … infection, subcutaneous hematomas and cerebrospinal fluid leak,” the researchers wrote; they found only a single example of subdural hematoma after an SCS implant in a literature review.

“Given the invasive nature of SCS, our data underscore that SCS reduced pain but should be applied as a last resort treatment and only should be carried out in specialized centers by a specialist with excellent experience in performing SCS treatment,” they wrote.

Disclosure: The study was supported by Medtronic.