OBJECTIVE: Aim of the study was to verify the efficacy of "mesodiencephalic" modulation (MDM), as named by the commercial promoters, in reducing symptoms accompanying painful diabetic neuropathy and in improving mental health.
METHODS: 32 patients with type 1 and 2 diabetes mellitus, with painful neuropathy, were enrolled in the prospective, double-blind, placebo-controlled, cross-over study. The modulation was performed using MDM electrotherapeutic device (ZAT a.s), sham modulation was used as a placebo. Pain relief (visual analogue scale-VAS; total symptom score-TSS) and changes in mental state (Beck Depression Inventory-BDI-II; OSWESTRY and SF-36 questionnaires) were evaluated.
RESULTS: The study was completed by 30 patients. Pain evaluation: VAS: pain relief was statistically insignificantly higher after real (R) compared to sham (S) modulation (-0.7 vs. -0.3; p=0.06), effect of both modulations was equal after 1 month (-0.4 vs. 0.0; p=0.46). TSS: the effect of R and S modulation did not differ immediately after the procedure (-1.3 vs. -1.0; p=0.27), nor after 1 month (-1.5 vs. -0.34; p=0.9). Psychological tests: according to SF-36, the physical health improved considerably after R compared to S (2.5 vs. -2.0; p<0.01), however, changes in the mental health were equal (-1.5 vs. 0.0; p=0.78). Oswestry (0 vs. 0; p=0.95) and BDI-II (-0.5 vs. -1.0; p=0.42) were comparable after R and S modulation. Order of the procedures (R vs. S) did not affect results.
CONCLUSION: The study did not demonstrate any positive effect of MDM on painful diabetic neuropathy compared to placebo, relative to pain or mental state evaluations. The study emphasizes the need of using placebo-controlled studies, especially when testing a new analgesic drug or a method for pain modulation.