OBJECTIVEPainful 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 METHODSWe 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. RESULTSTrial 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 < 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 < 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 < 0.001 and P < 0.05). One SCS patient died because of a subdural hematoma. CONCLUSIONSTreatment 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.Painful diabetic peripheral neuropathy (PDPN) is a common complication of diabetes mellitus (DM), and prevalence of PDPN ranges from 10 to 26% (1-3). In many patients, the pain is of such intensity that it has a major impact on patients' health-related quality of life (HRQoL) and functional ability, including interference with general activity, mood, mobility, work, social relations, sleep, and enjoyment of life (4).

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.

Corresponding authors: Maarten van Beek, m.vanbeek@maastrichtuniversity.nl, and Maarten van Kleef, maarten.van.kleef@mumc.nl.

SCS seems to be an efficacious and feasible treatment for intractable PDP. In this exploratory study, it was not possible to predict the treatment outcome using clinical sensory testing. These results justify performing a randomized clinical trial.

Available literature shows promising results for the pain-relieving effect of spinal cord stimulation in painful diabetic polyneuropathy. The outcome of a randomized clinical trial is needed before spinal cord stimulation can be considered to be integrated in the standardized treatment algorithm.