Measured Adherence Effect of Sling Treatment on Reported Outcomes
Research type
Research Study
Full title
Quantifying Sling Wear Adherence using Inertial Sensors and Impact on Reported Outcomes after Shoulder Surgery
IRAS ID
315132
Contact name
Harvinder Singh
Contact email
Sponsor organisation
University Hospitals of Leicester NHS Trust
Clinicaltrials.gov Identifier
153817, EDGE ID
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
A shoulder sling is routinely worn after shoulder surgery (whether for the repair of shoulder rotator tendons, or shoulder joint replacement for advanced wear and tear). It is not known if this sling wear actually has any bearing on the patient's function later on.
Asking patients about their duration of sling wear is not reliable as they may inadvertently over or underestimate their compliance. A simple yet effective way is to observe sling wear by suturing motion sensors in the slings worn by patients that would detect motion patterns related to sling donning and doffing.
The first part of this study was performed on normal volunteers who understood the aim of the study, to confirm the accuracy of these sensors in correctly identifying sling wear duration. Volunteers were asked to wear the pre-fitted slings but to freely take them off as per their convenience and to log their sling donning and doffing times. The accuracy of these sensors was confirmed to be over 97% by comparing measurements from these sensors with the duration logged by the volunteers themselves.Our study aims to use these proven high-accuracy pre-fitted slings in a clinical scenario. We will be consenting patients who had elective shoulder surgery to wear these pre-fitted slings to accurately observe their actual sling wear duration during the recommended treatment period. Patient questionnaires would be used to determine their outcomes and function at specific time points after the completion of the recommended sling wear duration. This will increase our understanding of adherence to the recommended sling wear and whether patient compliance after these surgeries has any bearing on patient outcomes and function.
This will help in future clinical practice by guiding a unique and accurate evidence-based recommendation for sling wear after shoulder surgeries and avoiding over or under-treatment with routine slings.
REC name
London - City & East Research Ethics Committee
REC reference
23/LO/0290
Date of REC Opinion
4 Jul 2023
REC opinion
Further Information Favourable Opinion