5 Frequency Rhythmic Electrical Modulation System (FREMS), a possible additional treatment for patients with therapy resistant diabetic neuropathy?
Schepens, M.E.W., Heijster, J.H., Imholz, B.P.M.
Locatie(s): Auditorium 2
Categorie(ën): Parallelsessie
Introduction: Diabetic neuropathy (DN) is a complication of diabetes mellitus (DM) that will occur in a significant part of the patients. Twenty-one percent of the patients with DN will eventually develop painful neuropathy. There are multiple pharmacological therapies available for painful DN, but these are not always sufficient. One of the alternative treatments is Frequency Rhythmic Electrical Modulation System (FREMS), which stimulates vasomotor activity and the production of neovascular growth factors. The effect on pain management has been demonstrated by two randomised controlled trials.
Aim of the study: A phase IV study to evaluate the effect of FREMS therapy on painful DN resistant to pharmacological treatments and to determine predictive factors for a response to FREMS therapy.
Materials and Methods: Seventy patients who had been unsuccessfully treated for DN according to the DN guideline were included and received FREMS therapy during ten sessions of forty minutes in fourteen days.The patients were seen at least three days before (control) and one (M1) and three (M3) months after treatment. They were evaluated for pain (neuropathic pain symptom inventory (NPSI)), quality of life (EQ-5 score), vibration perception (biothesiometer), mobility (sensewear) and the presence of glycation end products (AGEs) (AGE reader). We examined the following possible predictive factors: absolute pain score in rest, duration of DM, the average vibration threshold measured at the hallux and the presence of AGEs.
Results: Absolute pain scores were significantly improved after one and three months compared to control (p < 0,001). After one month the NPSI score was diminished with at least fifty percent in 23/70 patients and with at least thirtyfive percent in half of the patients. After three months the NPSI score was diminished with at least fifty percent in 19/66 patients and with at least thirty percent in half of the patients. The quality of life also improved significantly (M1 p = 0,001, M3 p = 0,01). There were no significant changes in vibration perception and mobility. There were no significant correlations found between the examined predictive factors and the response to FREMS therapy.
Conclusion: For patients with painful DN who do not respond to traditional pharmacological treatments, FREMS therapy may prove to be a valid alternative for over one third of the patients.