Local Vibrational Therapy for Essential Tremor Reduction: A Clinical Study
| العنوان: | Local Vibrational Therapy for Essential Tremor Reduction: A Clinical Study |
|---|---|
| المؤلفون: | Mantas Venslauskas, Vaidotas Gudžiūnas, Edgaras Stankevičius, Ovidijus Laucius, Silvijus Abramavicius, Antanas Vaitkus |
| المساهمون: | MDPI AG (Basel, Switzerland) |
| المصدر: | Medicina; Volume 56; Issue 10; Pages: 552 Medicina, Basel : MDPI, 2020, vol. 56, iss. 10, art. no. 552, p. 1-9 Medicina Volume 56 Issue 10 Medicina, Vol 56, Iss 552, p 552 (2020) |
| بيانات النشر: | Multidisciplinary Digital Publishing Institute, 2020. |
| سنة النشر: | 2020 |
| مصطلحات موضوعية: | Essential Tremor, Vibration, Article, Clinical study, vibrational therapy, 03 medical and health sciences, 0302 clinical medicine, Pharmacotherapy, Interquartile range, local hand-arm vibration, Tremor, Lack of efficacy, Clinical endpoint, Medicine, Humans, Prospective Studies, mechanical vibration, Adverse effect, lcsh:R5-920, Essential tremor, business.industry, essential tremor, essential tremor treatment, General Medicine, Device use, medicine.disease, 030210 environmental & occupational health, Anesthesia, Quality of Life, lcsh:Medicine (General), business, 030217 neurology & neurosurgery |
| الوصف: | Background and objectives: tremor is an unintentional and rhythmic movement of any part of the body that is a typical symptom of Essential Tremor (ET). ET impairs the quality of life of patients and is treated with pharmacotherapy. We investigated the tremor reduction efficacy of an innovative vibrational medical device (IMD) in ET patients. Materials and Methods: we conducted a prospective, single-center, single-arm, pragmatic study in ET patients with an extended safety study to evaluate the efficacy and safety of the Vilim Ball&mdash a local hand-arm vibration device that produces vibrations in the frequency range of 8&ndash 18 Hz and amplitude from 0 to 2 mm. The primary endpoint was the decrease in the power spectrum after device use. The secondary endpoints were safety outcomes. Results: In total, 17 patients with ET were included in the main study, and no patients withdrew from the main study. The tremor power spectrum (m2/s3 Hz) was lower after the device use, represented as the mean (standard deviation): 0.106 (0.221) median (Md) 0.009 with the interquartile range IQR, 0.087 vs. 0.042 (0.078) Md = 0.009 with the IQR 0.012 Wilcoxon signed-rank test V = 123 and p = 0.027. Seven patients reported that vibrational therapy was not effective. Two patients reported an increase in tremor after using the device. In the extended safety study, we included 51 patients: 31 patients with ET and 20 with Parkinsonian tremor, where 48 patients reported an improvement in tremor symptoms and 49 in function. No serious adverse events were reported, while two patients in the Parkinsonian tremor group reported a lack of efficacy of the proposed medical device. Conclusions: the device reduces essential tremor in some patients and is safe to use in ET. |
| وصف الملف: | application/pdf |
| اللغة: | English |
| تدمد: | 1648-9144 1010-660X |
| DOI: | 10.3390/medicina56100552 |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::8e6db9ef2a95a9c1fe86797f98f0d8c8 |
| حقوق: | OPEN |
| رقم الأكسشن: | edsair.doi.dedup.....8e6db9ef2a95a9c1fe86797f98f0d8c8 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 16489144 1010660X |
|---|---|
| DOI: | 10.3390/medicina56100552 |