Chair of Complementary Medicine, Center of Internal Medicine, Rostock University Medicine, Ernst-Heydemann-Straße 6, 18057 Rostock, Germany.
Evid Based Complement Alternat Med. 2013;2013:679248. doi: 10.1155/2013/679248. Epub 2013 Oct 3.
The objective of this study is to assess the safety of treatment with vibration massage using a deep oscillation device and the effects on symptom severity and quality of life in patients with primary fibromyalgia syndrome (FMS). Outpatients with FMS performed an observational prospective study with visits 2-4 weeks after the last treatment (control) and after further 2 months (follow-up). Patients were treated with 10 sessions of 45 min deep oscillation massage, 2/week. Primary outcome parameters were safety and tolerability (5-level Likert scale (1 = very good)) (after each treatment session and at control visit). Secondary outcome parameters were symptom severity (Fibromyalgia Impact Questionnaire (FIQ), pain) and quality of life (SF-36). Seventy patients (97.1% females) were included. At control visit, 41 patients (58.6%) reported 63 mild and short-lasting adverse events, mainly worsening of prevalent symptoms such as pain and fatigue. Tolerability was rated as 1.8 (95% confidence interval: 1.53; 2.07). Symptoms and quality of life were significantly improved at both control and follow-up visits (at least P < 0.01). In conclusion, deep oscillation massage is safe and well tolerated in patients with FMS and might improve symptoms and quality of life rather sustained.
本研究旨在评估使用深层振动按摩设备进行振动按摩治疗的安全性，并观察其对原发性纤维肌痛综合征（FMS）患者症状严重程度和生活质量的影响。门诊 FMS 患者进行了一项观察性前瞻性研究，在最后一次治疗（对照）后 2-4 周以及进一步 2 个月（随访）时进行访视。患者接受了 10 次 45 分钟深层振动按摩治疗，每周 2 次。主要结局参数是安全性和耐受性（5 级李克特量表（1=非常好））（每次治疗后和对照访视时）。次要结局参数为症状严重程度（纤维肌痛影响问卷（FIQ）、疼痛）和生活质量（SF-36）。70 例患者（97.1%为女性）入选。在对照访视时，41 例患者（58.6%）报告了 63 例轻度和短暂的不良事件，主要是疼痛和疲劳等常见症状加重。耐受性评分为 1.8（95%置信区间：1.53;2.07）。症状和生活质量在对照和随访访视时均显著改善（至少 P<0.01）。总之，深层振动按摩在 FMS 患者中安全且耐受性良好，可能会改善症状和生活质量，且改善效果持续。
