BACKGROUND The new physical Elosan therapy is designed to provide patients with chronic pain with clear relief, improve their quality of life and reduce the consumption of painkillers. To prove the efficacy and tolerability of this new therapy, a clinical pilot study had to be carried out to certify the Elosan Therapy Cabin as a medical device, since despite extensive literature research no equivalent product or therapy could be identified. METHODOLOGY In an open, randomized, clinical comparison study at three pain medical centers in Switzerland, a total of 39 patients with chronic pain (duration >6 months; intensity >50 mm visual analog scale (VAS) according to Borg) in two groups (21 verum, 18 control) were included in the study. The verum group received a 4-min Elosan therapy over a period of 28 days twice/week in addition to the further applied individual standard therapy. The control group continued to receive only their individual standard therapy. The primary target parameter was that the pain reduction in the verum group after 8 treatments should be at least 20 mm (100 mm partial VAS pain scale) more than in the control group. The secondary target parameters were a change in quality of life based on the Short Form (SF) 12 questionnaire and a relevant reduction in pain medication. RESULTS The most important result was in-group pain reduction (measured VAS score), which was highly significant in the Elosan group (p = 0.001). The treatment effect corresponded on average to a pain reduction of almost 25% with simultaneous administration of standard drug therapy. Overall, 2.5 times more patients in the Elosan group compared to the control group experienced a reduction of the VAS score of more than 20 mm (= pain reduction of at least 30%). Nevertheless, statistical significance was not fully achieved in the primary endpoint (p = 0.102). The result of the SF 12 questionnaire showed efficacy in the physical area, subitem: "Physical pain", which improved significantly in the verum group (p = 0.001). The total value of SF 12 in the mental area was significantly better in the Elosan treatment group than in the reference group (p = 0.016). The improvement in pain sensation was highly significantly better in the verum group (p = 0.001). Finally, about four times more patients in the Elosan group were able to reduce their pain medication towards the end of the study.

中文翻译：

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Elosan-Therapie

背景 新的物理 Elosan 疗法旨在为慢性疼痛患者提供明显的缓解，提高他们的生活质量并减少止痛药的消耗。为了证明这种新疗法的有效性和耐受性，必须进行一项临床试验研究，以证明 Elosan Therapy Cabin 是一种医疗设备，因为尽管进行了大量文献研究，但仍无法确定等效的产品或疗法。方法学 在瑞士三个疼痛医疗中心进行的一项开放、随机、临床比较研究中，共有 39 名慢性疼痛患者（持续时间 >6 个月；根据 Borg 的强度 >50 mm 视觉模拟量表 (VAS)）分为两组（ 21 名真人，18 名对照）被包括在研究中。除了进一步应用的个体标准治疗外，verum 组在 28 天的时间内每周两次接受 4 分钟的 Elosan 治疗。对照组继续仅接受他们个人的标准治疗。主要目标参数是 verum 组在 8 次治疗后的疼痛减轻应至少比对照组多 20 mm（100 mm 部分 VAS 疼痛量表）。次要目标参数是基于简表 (SF) 12 问卷的生活质量变化和相关的止痛药减少。结果 最重要的结果是组内疼痛减轻（测量的 VAS 评分），这在 Elosan 组中非常显着（p = 0.001）。治疗效果与同时给予标准药物治疗的疼痛平均减少近 25% 相对应。全面的，与对照组相比，Elosan 组患者的 VAS 评分降低超过 20 毫米（= 疼痛减轻至少 30%）的患者多 2.5 倍。然而，主要终点并未完全达到统计显着性（p = 0.102）。SF 12 问卷的结果显示在身体区域的疗效，子项：“身体疼痛”，在 verum 组中显着改善（p = 0.001）。Elosan 治疗组的精神区 SF 12 总值显着优于参考组（p = 0.016）。verum 组的痛觉改善明显更好（p = 0.001）。最后，在研究结束时，Elosan 组中能够减少止痛药的患者增加了大约四倍。与对照组相比，Elosan 组患者的 VAS 评分降低超过 20 毫米（= 疼痛减轻至少 30%）5 倍。然而，主要终点并未完全达到统计显着性（p = 0.102）。SF 12 问卷的结果显示在身体区域的疗效，子项：“身体疼痛”，在 verum 组中显着改善（p = 0.001）。Elosan 治疗组的精神区 SF 12 总值显着优于参考组（p = 0.016）。verum 组的痛觉改善明显更好（p = 0.001）。最后，在研究结束时，Elosan 组中能够减少止痛药的患者增加了大约四倍。与对照组相比，Elosan 组患者的 VAS 评分降低超过 20 毫米（= 疼痛减轻至少 30%）5 倍。然而，主要终点并未完全达到统计显着性（p = 0.102）。SF 12 问卷的结果显示在身体区域的疗效，子项：“身体疼痛”，在 verum 组中显着改善（p = 0.001）。Elosan 治疗组的精神区 SF 12 总值显着优于参考组（p = 0.016）。verum 组的痛觉改善明显更好（p = 0.001）。最后，在研究结束时，Elosan 组中能够减少止痛药用量的患者增加了约四倍。