F. Demartis, R. De Cristofaro, M. R. Fasulo, E. Boccalandro, A. Cobianco, E. Santagostino
Energy for Health [11], 2013
The aim of this study was to verify analgesic effects of High Intensity Laser Therapy (HILT) for the treatment of chronic artrhopathy in adult hemophilic patients and to verify its safety and tolerability. Eleven adult hemophilic patients of any degree with or without inhibitors, diagnosed with chronic artrhopathy, were enrolled in this pilot open-label study by three Hemophilia Treatment Centers. All patients were treated with 3 High Intensity Laser applications/week in the symptomatic joint for 3 consecutive weeks. Clinical evaluations assessed reactions at application site and skin reactions. Outcomes were defined as variations in the Nieschi's and VAS Scores and Hemophilia Joint Health Score 2.0, compared to the baseline, as well as documented adverse events (AE5) and serious adverse events (SAEs). At the end of the study, after 3 weeks of therapy, we recorded a statistically significant decrease of Nieschi's score (-19-2.47) and VAS score (-27.1-30.66) (both at P<0.05), while no statistical difference was observed between the basal and last visit with regard to HJH-2.0 scores, Three local reactions at the site of therapy were reported, two of which were non-severe and one (paresthesia) was of moderate intensity. Three adverse events were experienced, such as transient gonalgia of the right knee that was considered to be possibly related to the study treatment. No bleeding at the site of therapy application was reported. In this pilot study, HILT demonstrated a statistically significant analgesic effect for chronic artrhopaty in hemophilic adult patients: the analgesic effect was evident even after few treatment sessions and it was well tolerated with rare adverse events. Further studies have to be carried out to clarify if different doses and schedule applications could improve the clinical outcomes.
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Decreto Legislativo 24 febbraio 1997, n°46 Articolo 21
1. E' vietata la pubblicità verso il pubblico dei dispositivi che, secondo disposizioni adottate con decreto del Ministro della Sanità, possono essere venduti soltanto su prescrizione medica o essere impiegati eventualmente con l'assistenza di un medico o di altro professionista sanitario.
2. La pubblicità presso il pubblico dei dispositivi diversi da quelli di cui al comma 1 è soggetta ad autorizzazione del Ministero della Sanità. Sulle domande di autorizzazione esprime parere la Commissione di esperti prevista dall'articolo 6, comma 3, del decreto legislativo
30 dicembre 1992, n. 541, che a tal fine è integrata da un rappresentante del Dipartimento del Ministero della Sanità competente in materia di dispositivi medici e da uno del Ministero dell'Industria, del commercio e dell'artigianato.
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