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      Load-Induced Glenohumeral Translation After Rotator Cuff Tears: Protocol for an In Vivo Study

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          Abstract

          Background

          Rotator cuff tears are a common shoulder injury, but they sometimes remain undiagnosed, as symptoms can be limited. Altered shoulder biomechanics can lead to secondary damage and degeneration. In biomechanical analyses, the shoulder (ie, the glenohumeral joint) is normally idealized as a ball-and-socket joint, even though a translation is often observed clinically. To date, no conclusive changes in glenohumeral translation have been reported in patients with rotator cuff tears, and it is unknown how an additional handheld weight that is comparable to those used during daily activities will affect glenohumeral translations in patients with rotator cuff tears.

          Objective

          This study aims to assess the load-induced glenohumeral translation (liTr) in patients with rotator cuff tears and its association with the load-induced changes in muscle activation (liMA).

          Methods

          Patients and asymptomatic controls will be recruited. Participants will fill out health questionnaires and perform 30° arm abduction and adduction trials, during which they will hold different handheld weights of a maximum of 4 kg while motion capture and electromyographic data are collected. In addition, fluoroscopic images of the shoulders will be taken for the same movements. Isometric shoulder muscle strength for abduction and rotation will be assessed with a dynamometer. Finally, shoulder magnetic resonance images will be acquired to assess muscle status and injury presence. The dose-response relationship between additional weight, liTr, and liMA will be evaluated.

          Results

          Recruitment and data collection began in May 2021, and they will last until the recruitment target is achieved. Data collection is expected to be completed by the end of 2022. As of November 2022, data processing and analysis are in progress, and the first results are expected to be submitted for publication in 2023.

          Conclusions

          This study will aid our understanding of biological variations in liTr, the influence of disease pathology on liTr, the potential compensation of rotator cuff tears by muscle activation and size, and the association between liTr and patient outcomes. The outcomes will be relevant for diagnosis, treatment, and rehabilitation planning in patients with rotator cuff tears.

          Trial Registration

          ClinicalTrials.gov NCT04819724; https://clinicaltrials.gov/ct2/show/NCT04819724

          International Registered Report Identifier (IRRID)

          DERR1-10.2196/43769

          Related collections

          Most cited references53

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          Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support.

          Research electronic data capture (REDCap) is a novel workflow methodology and software solution designed for rapid development and deployment of electronic data capture tools to support clinical and translational research. We present: (1) a brief description of the REDCap metadata-driven software toolset; (2) detail concerning the capture and use of study-related metadata from scientific research teams; (3) measures of impact for REDCap; (4) details concerning a consortium network of domestic and international institutions collaborating on the project; and (5) strengths and limitations of the REDCap system. REDCap is currently supporting 286 translational research projects in a growing collaborative network including 27 active partner institutions.
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            The REDCap consortium: Building an international community of software platform partners

            The Research Electronic Data Capture (REDCap) data management platform was developed in 2004 to address an institutional need at Vanderbilt University, then shared with a limited number of adopting sites beginning in 2006. Given bi-directional benefit in early sharing experiments, we created a broader consortium sharing and support model for any academic, non-profit, or government partner wishing to adopt the software. Our sharing framework and consortium-based support model have evolved over time along with the size of the consortium (currently more than 3200 REDCap partners across 128 countries). While the "REDCap Consortium" model represents only one example of how to build and disseminate a software platform, lessons learned from our approach may assist other research institutions seeking to build and disseminate innovative technologies.
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              Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L)

              Purpose This article introduces the new 5-level EQ-5D (EQ-5D-5L) health status measure. Methods EQ-5D currently measures health using three levels of severity in five dimensions. A EuroQol Group task force was established to find ways of improving the instrument’s sensitivity and reducing ceiling effects by increasing the number of severity levels. The study was performed in the United Kingdom and Spain. Severity labels for 5 levels in each dimension were identified using response scaling. Focus groups were used to investigate the face and content validity of the new versions, including hypothetical health states generated from those versions. Results Selecting labels at approximately the 25th, 50th, and 75th centiles produced two alternative 5-level versions. Focus group work showed a slight preference for the wording ‘slight-moderate-severe’ problems, with anchors of ‘no problems’ and ‘unable to do’ in the EQ-5D functional dimensions. Similar wording was used in the Pain/Discomfort and Anxiety/Depression dimensions. Hypothetical health states were well understood though participants stressed the need for the internal coherence of health states. Conclusions A 5-level version of the EQ-5D has been developed by the EuroQol Group. Further testing is required to determine whether the new version improves sensitivity and reduces ceiling effects.
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                Author and article information

                Contributors
                Journal
                JMIR Res Protoc
                JMIR Res Protoc
                ResProt
                JMIR Research Protocols
                JMIR Publications (Toronto, Canada )
                1929-0748
                December 2022
                23 December 2022
                : 11
                : 12
                : e43769
                Affiliations
                [1 ] Department of Orthopaedics and Traumatology University Hospital Basel Basel Switzerland
                [2 ] Department of Biomedical Engineering University of Basel Basel Switzerland
                [3 ] Department of Clinical Research University of Basel Basel Switzerland
                [4 ] Department of Spine Surgery University Hospital Basel Basel Switzerland
                [5 ] Meta-Research Centre Department of Clinical Research University Hospital Basel Basel Switzerland
                [6 ] Department of Radiology University Hospital Basel Basel Switzerland
                [7 ] Institute of Mechanical Systems Zurich University of Applied Sciences Winterthur Switzerland
                Author notes
                Corresponding Author: Eleonora Croci eleonora.croci@ 123456unibas.ch
                Author information
                https://orcid.org/0000-0001-9357-3681
                https://orcid.org/0000-0002-7670-4229
                https://orcid.org/0000-0002-7526-9536
                https://orcid.org/0000-0003-0180-3246
                https://orcid.org/0000-0003-1515-0928
                https://orcid.org/0000-0002-6779-7988
                https://orcid.org/0000-0002-6077-2905
                https://orcid.org/0000-0003-2726-3428
                https://orcid.org/0000-0002-6472-1689
                Article
                v11i12e43769
                10.2196/43769
                9823567
                36563028
                379eab2f-0aaf-4764-83a3-f242fb1d5801
                ©Eleonora Croci, Franziska Eckers, Corina Nüesch, Soheila Aghlmandi, Balazs Krisztian Kovacs, Jeremy Genter, Daniel Baumgartner, Andreas Marc Müller, Annegret Mündermann. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 23.12.2022.

                This is an open-access article distributed under the terms of the Creative Commons Attribution License ( https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on https://www.researchprotocols.org, as well as this copyright and license information must be included.

                History
                : 24 October 2022
                : 23 November 2022
                : 28 November 2022
                : 30 November 2022
                Categories
                Protocol
                Protocol
                Custom metadata
                This paper was peer reviewed by the Swiss National Science Foundation (Bern, Switzerland). See the Multimedia Appendix for the peer-review report;

                abduction,shoulder,rotator cuff,humeral head migration,fluoroscopy,mri,motion capture,dynamometer

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