Electrical stimulation therapy through stocking electrodes for painful diabetic neuropathy: a double blind, controlled crossover study.

AIMS: Peripheral neuropathy affects more than a third of diabetic patients, of whom a significant minority will have disabling symptoms. The aim of this study was to assess the efficacy of pulsed-dose electrical stimulation (through stocking electrodes) in the treatment of painful diabetic neuropathy.
METHODS: Thirty patients with painful diabetic neuropathy were consecutively randomised to wear silver-plated nylon-dacron stocking electrodes for 8 h a night for 6 weeks (pulsed electric current of 50 micro amps delivered by a microcomputer). The control, identical stockings received an insignificant current (5 micro amps). Pre-treatment, weekly and end-of-treatment pain and sleep disturbance scores were recorded.
RESULTS: Fourteen patients completed the study (the 16 non-completers withdrew during the first phase). Mean (+/- sd) age: 57.5 +/- 10.5 years; HbA(1c): 8.3 +/- 1.4%; median (IQR) duration of diabetes: 14.5 (7.6-19.3) years; duration of neuropathy: 4 (3-7) years. Active treatment and control produced similar reductions in pain scores [median (IQR): 40.1 (4.7-97.7)% vs. 49.2 (0.2-91.1)%, P = 0.70] and sleep disturbance scores [median (IQR): 31.1 (-4.6 to 85.4)% vs. 42.6 (-16.2 to 91.1)%, P = 0.70]. Non-completers (seven on active treatment, nine on control) withdrew for similar reasons (inconvenience, exacerbation of symptoms, dermatitis).
CONCLUSIONS: There is no evidence from these results that this treatment is more effective than control in the treatment of painful diabetic neuropathy. Copyright 2004 Diabetes UK

RCT Entities:   Population Interventions Outcomes