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

Abstract

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.

Keywords:

• microcurrent therapy
• pain
• anxiety
• sleep disturbances

Acknowledgments

Mrs. Annemarie Blam contributed as investigator in the study; she performed the remote study visits with the participants and verified the inclusion/exclusion criteria. Mrs. Stephanie Reddig drafted some essential study documents, performed the submission to the ethics committee and contributed to data management activities. Mr. Georg Salcher reviewed the first draft version of this report.

Disclosure

PM is an employee of Healy GmbH, the sponsor of the study. WW received consulting fees from Healy GmbH. The authors report no other conflicts of interest in this work.