Fernández-Jané, Carles http://orcid.org/0000-0002-0317-0967
Vilaró, Jordi
Funding for this research was provided by:
Professional College of Physiotherapists of Catalonia (R03/16)
Socientat Científica d'acupuntura de Catalunya i les Balears (2016)
Article History
Received: 5 March 2019
Accepted: 26 September 2019
First Online: 11 December 2019
Ethics approval and consent to participate
: This protocol was approved by the research ethics committee of each centre (identification codes 2018/8153/I and CEI 17/97), has been registered in ClinicalTrials.gov (NCT02998957) and will be published in open access. All protocol modifications will be informed to all lead investigators and reported in the final manuscript. All patients will be informed about the nature of the study, its objective, and the possible adverse effects of the treatments as well as their voluntary participation. All patients must sign an informed consent form. The patients will be able to leave the study whenever they want without any detriment to their health care. The data collected during the study will be treated in accordance with the LOPD, Regulation (EU) n°2016 / 679 of the European Parliament and European Council on data protection (RGPD) that came into force on 25 May 2018. Data monitoring is not needed as the treatment used is expected to have a low safety risk. For the same reason, no interim analysis or stopping guidelines or post-trial care and compensations are considered. No additional insurance was needed for this trial since the TENS device is regularly used in the rehabilitation department. Results of the trial will be disseminated via publication. Authorship eligibility will be considered in accordance with the International Committee of Medical Journal Editors criteria. A professional writer will be used to review the final manuscript.
: Not applicable.
: The authors declare that they have no competing interests.