Efficacy and Safety of TENS and Duloxetine in Patients with Painful Diabetic Neuropathy: A Single Blind Randomized Clinical Trial

Abstract: Background and Objective: Both duloxetine (DLX) and transcutaneous electrical nerve stimulation (TENS) are recommended as safe and effective treatments for diabetic peripheral neuropathic pain. However, these methods have not been compared. This study aimed to compare the efficacy of treatment by DLX and TENS in diabetic neuropathy pain relief. Materials and Methods: This survey was performed on 60 eligible diabetic patients randomly divided into two groups of DLX (20, 40, and 60 mg/day for weeks 1, 2, and 3-12, respectively), and TENS (20 min,80 HZ, 50 Amp, 0.2 ms Square pulses 2-3 times sensory threshold). The participants were evaluated according to the numerical rating scale (NRS) after four and twelve weeks of treatment. Moreover, adverse drug reactions were documented during the study period. Results: Baseline demographic data had no significant difference between the two groups (P≥0.05). The average NRS scores were significantly lower in the DLX group in both measurement times. At the end of weeks four (P=0.01) and 12 (P=0.001), the trend of changes was significant from baseline to the third month (P=0.0001). No patient in the TENS group reported any side effects, while 18% did in the DLX group. Conclusion: We found that both DLX and TENS were effective and safe for the management of painful diabetic neuropathy. The DLX seemed to be better, compared to TENS. However, in some conditions, such as drug intolerance or contraindication for medications, TENS could be a proper intervention. Keywords: Duloxetine, Painful diabetic neuropathy, TEN