Funding for this research was provided by:
Received: 18 December 2017
Accepted: 25 January 2018
First Online: 2 March 2018
Ethics approval and consent to participate
: The trial protocol, the informed consent forms and other requested documents have been reviewed and approved by the Capitol Regional Ethics Committee in Denmark (H-16016763) with respect to the scientific content and the compliance to the applicable health science regulations. Safety reports, containing a list of all serious side effects and serious events, will be sent to the ethics committee. Within 90 days after completion of the study, the sponsor and the primary investigator will inform the ethics committee that the study is closed. Consent or assent At the end of the medical examination, the treating orthopaedic specialist or the cooperating nurse will introduce the trial to patients fulfilling the eligibility criteria. Patients will be informed about the request for participation in the trial, and will be provided with participant information and a brochure on test subject’s rights. As soon as possible thereafter, patients will be contacted by one of the investigators. A final eligibility screening will be conducted and eligible patients will be offered a meeting to provide oral information about the trial, their rights as test subjects and the possibility to ask clarifying questions. Patients are offered deliberation time before being asked to sign written consent forms regarding willingness to participate. Consent or assent – ancillary studies In the oral information and in the participant information sheets, patients will be informed that a 1 year follow-up is planned for all participants, and that this is covered by the written consent forms. Data for the 1 year follow-up will, in part, be collected through text messages, using the SMS-trackSuperscript removed (data hosted at a BFIH certified data centre that meets the ISO 27002 standards). Through answers to auto-generated standardized SMS questions, patients will be asked to report sick leave due to their shoulder disorder (weekly). Questions regarding surgery, if any, for SIS (yearly), the EQ-5D-3 L questionnaire (yearly), and all questions from the SPADI questionnaire (after 6 months and 1 year) will be administered using the REDCapSuperscript removed system. Confidentiality All study-related information on participants will be stored securely on the study site. All completed paper forms will be stored in locked file cabinets before and after data is entered to an electronic database. All electronic participants’ information will be stored on a secured study-specific drive at the study site. Access to the study-specific drive will be limited to users currently working on the project and therefore need access to the secured drive in order to store and/or analyse data. Access will be limited by individual person-specific login and passwords. A list of persons with access to the study-specific drive will be kept up-to-date by the primary investigator. Appointment schedules and any other listings that link participant to other identifying information will be stored separately in the hospital’s secured intranet system or in separate locked file cabinets in an area with limited access. Study information will not be released outside of the study without the permission of the relevant participant. The study will be reported to and approved by the Danish Data Protection Agency before start of inclusion, and will adhere to the “Act on Processing Personal Data”. Ancillary and post-trial care In general, no ancillary or post-trial care is provided to participants in the trial. However, the details of the intervention will be made public shortly after the trial is over, and the intervention could therefore be replicated by physiotherapists in ordinary settings.
: Written informed consent for publication of images in the intervention leaflet was obtained from the person appearing on the pictures. A copy of the consent form is available for review by the Editor of this journal.
: The authors declare that they have no competing interests.
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