Funding for this research was provided by:
Rittal Foundation (no number)
J. J. Darboven (No number)
Bürgerstiftung Siegen (No number)
Article History
Received: 9 March 2020
Accepted: 5 October 2020
First Online: 15 October 2020
Ethics approval and consent to participate
: The study is registered in the German Clinical Trial Register under DRKS00017010 and will be conducted in accordance with principles enunciated in the current Declaration of Helsinki (DoH) and the guidelines of Good Clinical Practice (GCP) issued by the International Conference on Harmonisation (ICH). Ethics approval has been obtained for the study, and any amendment will be duly submitted for approval. Approved protocol amendments are forwarded to the therapists, and they are trained accordingly when it comes to conducting the study. The trial registry and the Ethics Committee will be informed accordingly.Participation in the study is voluntary, and the participants will be informed of the study conditions in detail and an opportunity will be given to discuss and clarify specific questions. Ethical challenges may arise as a result of randomisation. However, the control group is offered a minimal intervention consisting of 3 units after the follow-up period.The study participants are informed that their disease- and personal data will be stored in pseudonymized form and used for scientific evaluation. The study participants have the right to be informed about the stored data. The therapists sign a self-commitment for confidentiality.
: Not applicable.
: The authors declare that they have no competing interests.