Observational Study to Assesses the Efficacy and Safety of Microcurrent Therapy with a Portable Device in Patients Suffering from Chronic Back Pain, Skeletal System Pain, Fibromyalgia, Migraine or Depression

Purpose: In Germany, there are several microcurrent medical devices that are certified for the treatment of patients suffering from one of the indications chronic back pain, skeletal system pain, fibromyalgia, migraine or depression. While certification is based on controlled, randomized clinical trials, evidence of efficacy and safety under real-world conditions is limited to very few observational studies. To fill this gap, this study was conducted.

Patients and methods: Fifty patients per indication already using the investigational device before study entry were included and followed for a total 6 months. Each participant used the Healy in an individualized schedule to optimize the treatment of his/her special indication. This means that each participant performed on average 1-2 microcurrent applications per day for 20 to 30 minutes each. In all indications, the improvement of health-related quality of life was assessed by the SF-36 questionnaire and other validated indication specific surveys.

Results: In all indications, the improvement of health-related quality of life as assessed by the SF-36 questionnaire was statistically highly significant and clinically relevant. These findings were supported by more specific outcome measures applied in each indication. Only four adverse events related to the application of microcurrent occurred during the trial.

Conclusion: Microcurrent therapy has been demonstrated to be efficient and safe under real-world conditions for the treatment of each of the conditions for which the device is certified.