Feasibility study of an evaluation tool for tendonitis of the shoulder

This study has been completed as a pilot study with the hopes that a future larger study could be considered to look at the prospect of having a clinical evaluation tool which would expedite clinical management of shoulder issues and limit unnecessary use of imaging.

An examination protocol had been developed with some reference to the shoulder anatomy and functions, and with the idea supported by literature that several examination tools would always be better than the occasional single, named test, leading to a diagnosis. Some comments were made by kinesiologists to support the principles used and a smaller retrospective trial done previously by the investigator had supported the idea of looking deeper into this tool.

Participants were limited to community or teaching center community based family practices that are associated with McMaster Family Practice in Halton and Hamilton areas.

Ethics approval was obtained, and finances were approved and tracked for administration staff and uninsured radiology expenses, and potential patient travel expenses.

Physician participants were introduced to the study via emails, personal contact through general educational meetings, and through specially arranged meetings as part of continuing staff education events, to educate on the topic and tool. Case studies were created to demonstrate concepts, and flow sheets and diagrams of movements and anatomy were shared.

Information guides on the protocol and consent process were printed for physician and patient participants. For enrolled patients, a clinical examination flow sheet was used to score various diagnostic entities to see if a certain clinical diagnosis was suggested by the tool, which could be tendonitis of any kind (vs. other causes such as osteoarthritis),  and subtypes such as supraspinatus, infraspinatus, subscapularis or other.

The clinical flow sheets were faxed to the study administrator, including gender, age, physician ID, patient ID for physician use of results at later times. Patients would have ultrasound bookings with our approved sites made with their permission through the help of the administrator, and an offer was available for parking reimbursement.

Ultrasound results were later matched by case number and a flow sheet showing the anonymized demographics and clinical diagnosis and ultrasound presumed gold standard diagnosis. 2×2 tables were made comparing pos neg clinical diagnosis to pos neg ultrasound diagnosis. We could note that after seeing some of the imaging reports in this smaller sample size, we decided to document from this data the reports where findings showed some pathology in the expected areas, which would imply some unseen underlying tendonitis may be possible, such as local bursitis around a tendon. The data (taking into account that prevalence of tendonitis clinical diagnosis was not an issue) could be looked at for measure of the clinical tool for sensitivity, specificity, etc.

The other focus of this study was the protocol itself. One challenge was recruitment of physician participants who may have lacked confidence to do the evaluations. We offered a survey to participants of those invited who may not have participated in the study to look with some directed and some open-ended questions on the experience with the hopes of improving efficiency and ease of future study participation. Feedback was collected informally but allowed the process to involve and that real-time feedback proved to be preferred over after-the-fact questioning which did not result in any new ideas coming forth.