[Elosan therapy : A new treatment option for chronic pain].

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.