Der Schmerz
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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. ⋯ 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.