A Safety Study for Long-Time Use of a Novel Pain Management Device, AT-04

Abstract

Abstract Fibromyalgia is a common chronic pain disorder characterized by widespread pain and tenderness in mostly tendon attachments with unknown etiology. Treatment of fibromyalgia is mainly drug and other treatments, especially cognitive behavioral therapy and exercise therapy combined. However, drugs for fibromyalgia have, in general, broad adverse effects. Thus, an unmet medical need remains for effective therapeutic modalities for fibromyalgia. We have recently developed a new magnetic medical device (project code “AT”) that has alternating magnetic fields and stimulates the affected area for pain relief. In the pilot study, AT treatment (twice daily for 10 min) tended to reduce the mean NRS (Numerical Rating Scale) pain score. Moreover, we demonstrated long treatment (30 min) suppressed LPS-induced (Lipopolysaccharide-induced) mRNA IL-6 expression compared with 10-min treatment in vitro. These results assumed that long treatment has high efficiency. To evaluate the safety of long time (120 min/day) AT treatment for 12 weeks. Single center, prospective, open-label, single-arm, intervention study to demonstrate the safety of long-time use of AT in 5 healthy Japanese volunteers to 12 weeks. During the intervention period, all of the adverse events were measured. The represents of AT treatment was 99.8 % in 5 subjects. The average and median exposure time of the study device was 135 min per day and 132 min per day, respectively. There were 3 nonserious adverse events and no serious adverse events during this study. This study tested long-time use of AT among 5 healthy subjects in Japan and showed that it did not pose any significant safety concerns. Because there are in-house in vitro data suggesting that the longer exposure of AT achieves a greater effect, the result of this study may allow us to conduct further studies to confirm more effectiveness and safety of long-time use of AT in a larger scale of clinical trial.