Comparing the Efficacy of Duloxetine with High Tone Power Therapy in Diabetic Peripheral Neuropathic Pain: A Double-Blind Randomized Phase III Clinical Trial

Background and Objective: Diabetic neuropathy pain is a common pain condition that has a major negative impact on health-related quality of life. However, despite many studies, it remains difficult to treat neuropathic pain. This study aimed to compare the efficacy of duloxetine with high tone power therapy (HTPT) in diabetic peripheral neuropathic pain. Materials and Methods: The study is a single-centre, phase III clinical trial comparing the effect of HTPT versus treatment with duloxetine in diagnosed diabetic neuropathy patients between October ۲۰۱۹ to December ۲۰۲۰. In the case group, the HTPT was used with a four-second duration for ۳۰ minutes daily. This treatment was continued twice a week for ۱۰ sessions. The control group received duloxetine (۳۰ mg/m۲ once a day). The treatment response was assessed based on the VAS score. Results: The results showed that in both groups, there was a significant reduction in pain severity. In HTPT group, the average pain decreased from ۷.۳۶ to ۴.۶ and in duloxetine group from ۷.۷ to ۴.۸. During ۸ measurements after the intervention; decrease in VAS score was higher in HTPT group (۵.۶) than in duloxetine group (۶.۵) in the first and fourth times after the intervention (P-Value=۰.۰۱). Further analysis demonstrated a positive correlation between pain severity and age so that, the pain also increases with  advancing age. Conclusion: The results of the present study showed that both duloxetine and high tone therapies are safe and effective methods for neuropathic pain relief.

Keywords:

Diabetic neuropathy , Duloxetine , TENS