Introduction Restless Legs Syndrome (RLS) is a sensorimotor neurological condition characterized by an uncontrollable urge to move the legs that interferes with falling and staying asleep. For the over 5 million Americans with clinically significant RLS, these symptoms occur multiple nights per week, significantly impair quality of life, increase the prevalence of depression and anxiety, and increase suicide risk. FDA-approved medications for RLS are associated with progressively worsening RLS symptoms and numerous adverse events, whereas existing medical device treatments have limited efficacy. Methods We evaluated a novel neurostimulation intervention for RLS developed by Noctrix Health; electrical stimulation was applied non-invasively and bilaterally to the peroneal nerve of patients with moderate-to-severe primary RLS. Stimulation parameters were engineered to maximize therapeutic efficacy while minimizing interference with sleep. To assess the therapeutic efficacy of this technique, we conducted a multi-site randomized patient-blinded crossover trial comparing active neurostimulation treatment to a sham device. Following a lab visit for calibration, optimization, and training, each patient was instructed to self-administer each treatment - active and sham - for 14 consecutive nights at home. Results Active neurostimulation treatment resulted in a clinically significant reduction in RLS severity of 4.2 points on the International RLS Rating Scale (IRLS) relative to sham (P<0.01), comparable to FDA-approved medications. Moreover, 79% of patients demonstrated a clinically significant improvement on the Clinical Global Impressions-Improvement scale (CGI-I) compared to 7% for sham (P<0.01). Conclusion To our knowledge, this is the first sham-controlled study demonstrating a clinically significant reduction in RLS severity resulting from a non-pharmacological intervention. This therapeutic effect was sustained over 2-weeks of in-home patient-administered usage, indicating consistent efficacy. A medical device based on this technology could be a promising alternative or complement to medications. Support Funding was provided by Noctrix Health, Inc.
Early sport specialization (ESS) is common among adolescent athletes due to desire of reaching elite status; however, the long-term impact of ESS on sports injury (SI) rates is not fully understood. We performed a systematic review and meta-analysis of the literature to evaluate the effect of ESS on SI rates during elite sport participation. Search included PubMed, Web of Science, SPORTDiscus, EMBASE, Cochrane, CINAHL, ERIC, and Medline databases. Preferred Reporting Items for Systematic Reviews and MetaAnalyses (PRISMA) guidelines were followed to identify published peer-reviewed articles from inception to 23 March 2023. Eligible studies reported numbers of elite athletes in collegiate, national, and professional teams in ESS and their counterpart category, as well as the portion of each group with at least one SI. Studies on concussion or non-contact injuries, or without explicit injury reports during elite sprot participation were excluded. Five articles were included in the review; 3 reported SIs on collegiate and 2 reported on professional athletes. A total of 3087 athletes were included (ESS = 45%). The overall effect was not significant and demonstrated that ESS athletes had a lower odd (OR=0.7) of a SI during elite sport participation. Articles with clear reports are scarce, and thus limit the impact of the findings in this study. High heterogeneity was evident in this analysis, largely due to lack of standardized terminology, evaluation, and data representation. Prospective studies that consider diverse athlete population of the same sport are warranted.
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