RT Journal Article
T1 Effects of a web application based on multimedia animations to support therapeutic exercise for rotator cuff-related shoulder pain: protocol for an open-label randomised controlled trial
A1 Pérez-Porta, Irene
A1 Flórez-García, Mariano Tomás
A1 García-Pérez, Fernando
A1 Fernández-Matías, Rubén
A1 Pérez-Manzanero, M Ángeles
A1 Araujo-Narváez, Aurora María
A1 Urraca-Gesto, M Alicia
A1 Fernández-Lagarejos, César
A1 Plaza Manzano, Gustavo
A1 Pérez-Fernández, Elia
A1 Velasco-Arribas, María
AB IntroductionRotator cuff-related shoulder pain (RCRSP) is the most common cause of shoulder pain. Currently, exercise is proposed as the first-line treatment for patients suffering from RCRSP. However, adherence to therapeutic exercise programmes can be poor in the long term in a home setting. The aim of this study is to evaluate the effects of adding video animations to a traditional paper-based exercise programme.Methods and analysisA single-centre, randomised, open-labelled clinical trial will be conducted in a hospital in Spain. Adults aged between 18 and 80 years diagnosed with RCRSP who meet the eligibility criteria will be included. Patients (n=132) will be randomised into two groups, with both receiving paper-based exercises, and the experimental group will also be provided with video animations. The participants will receive seven face-to-face physical therapy sessions and will be asked to perform the exercises at home for 6 months. The primary outcome measure will be the Shoulder Pain and Disability Index, measured at baseline, 3 weeks, 3 months (primary analysis) and 6 months. Secondary outcomes will be the patient’s pain intensity during the last week (rest, during movement and at night); expectations of improvement; satisfaction with treatment; impression of improvement; perceived usability, usefulness and satisfaction of multimedia animations; and adherence to exercises. Generalised least squares regression models with an autoregressive-moving average lag one correlation structure will be implemented, with an intention-to-treat analysis.Ethics and disseminationThis study has been approved by the ethics committee of Hospital Universitario Fundación Alcorcón (Madrid, Spain), reference number CI18/16. All participants will sign an informed consent. The results will be published in a peer-reviewed scientific journal.Trial registrationClinicalTrials.gov,NCT05770908.
PB BMJ Publishing Group Ltd
SN 2044-6055
YR 2024
FD 2024-07-02
LK https://hdl.handle.net/20.500.14352/121334
UL https://hdl.handle.net/20.500.14352/121334
LA eng
NO Pérez-Porta I, Flórez-García MT, García-Pérez F, Fernández-Matías R, Pérez-Manzanero MÁ, Araujo-Narváez AM, et al. Effects of a web application based on multimedia animations to support therapeutic exercise for rotator cuff-related shoulder pain: protocol for an open-label randomised controlled trial. BMJ Open. 2024;14(7).
NO Este ensayo ha recibido financiación del Instituto de Salud Carlos III y la Unión Europea (PI19/01490). El financiador no tiene influencia en el diseño, ejecución, análisis o publicación de los resultados del estudio.
DS Docta Complutense
RD 16 jun 2025