Effectiveness of the frequency rhythmic electrical modulation system for the treatment of chronic and painful venous leg ulcers in older adults.

Frequency rhythmic electrical modulation system (FREMS) is an innovative type of transcutaneous electrotherapy used in a rehabilitation setting for the treatment of pain, especially in diabetic patients. In a randomized clinical trial, we tested the hypothesis that FREMS is effective in the treatment of chronic and painful venous leg ulcers in 20 older patients. Group A (10 patients) received FREMS and topical treatment, whereas group B (10 patients) received topical treatment alone. Over a period of 3 consecutive weeks, 15 treatment sessions were done for each group. Wound healing and tissue repair were evaluated with the Visitrack digital planimetry system and photos. Pain was evaluated using the Visual Analogic Scale (VAS). The measurements were done at baseline and after 5, 10, and 15 days of treatment, with follow-up measurements after 15 and 30 days from the last treatment session. Group A showed a statistically significant decrease in ulcer area during the treatment and follow-up. The VAS score showed a statistically significant decrease after 5 and 10 days of treatment. Group B showed a statistically decrease in ulcer area after 5, 10, and 15 days of treatment with a reduction of VAS score only at 15 days of follow-up. At the end of the treatment, the comparison of the change in ulcer area and the change in VAS score of each group showed a statistically significant difference between groups, suggesting the therapeutic and analgesic efficacy of FREMS in reducing pain and area of chronic venous leg ulcers in older adults. Further investigation is needed to determine its reproducibility in larger case series or randomized clinical trials with longer follow-up periods.

RCT Entities:   Population Interventions Outcomes