For the approval as a medical device as well as in the framework of the PMCF, various studies were conducted to clarify efficacy, safety and mechanism of action.
A first clinical study on a chronic pain population confirms a good efficacy in the reduction of various chronic pain symptoms. Based on this, the clinical follow-up study in 8 centres shows similarly good results.
Elosan therapy does indeed have a positive impact on pain experience in different chronic pain conditions, which is very encouraging considering the treatment resistance of chronic pain. Given the current precarious social and economic impact of chronic pain disorders, effective, low-cost and low side-effect alternative treatment modalities are of utmost relevance.
The additional challenge is that due to the novelty of the treatment modality, no systematic basic studies exist yet regarding the underlying mechanisms of action. The Innosuisse project is therefore conducting a systematic investigation into the mechanism of action.
Comment by the principal investigator of the pivotal study
"The treatment with the Elosan therapy cabin C1 expands the spectrum of therapy options for patients with chronic and acute pain by an effective, side-effect-free, well-tolerated and non-medicinal physical treatment option. The therapy is time-saving, can be delegated and is not stressful or dangerous for the patients."
Petra Hoederath, MD
Head of Multimodal Pain Therapy
Hirslanden Clinic Stephanshorn, St.Gallen