Background Conventional treatment for painful peripheral diabetic neur
opathy is largely symptomatic and often ineffective, with unacceptable
side-effects. We tested electrical spinal-cord stimulation for the ma
nagement of chronic neuropathic pain, Methods Ten diabetic patients wh
o did not respond to conventional treatment (mean age 51 [SD 9.3] year
s, six with type II diabetes, mean duration of diabetes 12 [6.3] years
, mean duration of neuropathy 5 [2.1] years) were studied. The electro
de was implanted in the thoracic/lumbar epidural space. Immediate neur
opathic pain relief was assessed by visual analogue scale (VAS) after
connecting the electrode, in a random order, to a percutaneous electri
cal stimulator or to a placebo stimulator, Exercise tolerance was asse
ssed on a treadmill. Findings Eight subjects had statistically signifi
cant pain relief with the electrical stimulator (p<0.02) and were ther
efore converted to a permanent system, Statisically significant relief
of both background and peak neuropathic pain was achieved at 3 months
(n=7, p=0.016), at 6 months (n=7, p=0.03), and at the end of the stud
y (14 months, n=7, background pain p=0.06, peak pain p=0.03). One pati
ent died 2 months after the start of the study of unrelated cause whil
e continuing to benefit from treatment and another patient ceased to b
enefit at 4 months. McGill pain questionnaire scores with the stimulat
or turned off did not change significantly from baseline scores, indic
ating that the severity of the underlying pain was unaltered. However,
with the stimulator turned on, there was a statistically significant
(p<0.05) improvement in all four components of the score, by the end o
f the study. At the end of the study, six patients continued to gain s
ignificant pain relief and used the stimulator as the sole treatment f
or their neuropathic pain. For example, median background and peak pai
n scores at the end of study, were, respectively, 77 and 81 with the s
timulator off and 23 and 20 with the stimulator on. Exercise tolerance
significantly improved at 3 months (n=7, median % increase 85 [IQR, 6
2-360], p=0.015) and at 6 months (n=6, 163 [61-425], p=0.0007). Electr
ophysiological tests, vibration perception-threshold, and glycaemic co
ntrol were unchanged. Interpretation Electrical spinal-cord stimulatio
n offers a new and effective way of relieving chronic diabetic neuropa
thic pain and improves exercise tolerance. The technique should be con
sidered in patients with neuropathic pain who do not respond to conven
tional treatment.