MyBack - effectiveness and implementation of a behavior change informed exercise programme to prevent low back pain recurrences: a hybrid effectiveness-implementation randomized controlled study protocol.

Autor: Pires D; Instituto Politécnico de Setúbal, Escola Superior de Saúde, Setúbal, Portugal. diogo.pires@ess.ips.pt.; Comprehensive Health Research Centre, NOVA Medical School, Universidade Nova de Lisboa, Lisboa, Portugal. diogo.pires@ess.ips.pt., Duarte S; Instituto Politécnico de Setúbal, Escola Superior de Saúde, Setúbal, Portugal.; Comprehensive Health Research Centre, NOVA Medical School, Universidade Nova de Lisboa, Lisboa, Portugal.; NOVA National School of Public Health, Public Health Research Centre, Comprehensive Health Research Center, CHRC, NOVA University Lisbon, Lisboa, Portugal., Rodrigues AM; Comprehensive Health Research Centre, NOVA Medical School, Universidade Nova de Lisboa, Lisboa, Portugal.; EpiDoC Unit, NOVA Medical School, NOVA University of Lisbon, Lisboa, Portugal.; Unidade de Reumatologia, Hospital dos Lusíadas, Lisboa, Portugal., Caeiro C; Instituto Politécnico de Setúbal, Escola Superior de Saúde, Setúbal, Portugal.; Comprehensive Health Research Centre, NOVA Medical School, Universidade Nova de Lisboa, Lisboa, Portugal., Canhão H; Comprehensive Health Research Centre, NOVA Medical School, Universidade Nova de Lisboa, Lisboa, Portugal.; EpiDoC Unit, NOVA Medical School, NOVA University of Lisbon, Lisboa, Portugal.; Unidade de Reumatologia, CHULC Hospital Santo António dos Capuchos, Lisboa, Portugal., Branco J; Comprehensive Health Research Centre, NOVA Medical School, Universidade Nova de Lisboa, Lisboa, Portugal.; EpiDoC Unit, NOVA Medical School, NOVA University of Lisbon, Lisboa, Portugal.; Serviço de Reumatologia do Hospital Egas Moniz-Centro Hospitalar Lisboa Ocidental, Lisboa, Portugal., Alves J; NOVA National School of Public Health, Public Health Research Centre, Comprehensive Health Research Center, CHRC, NOVA University Lisbon, Lisboa, Portugal., Marques M; Comprehensive Health Research Centre, NOVA Medical School, Universidade Nova de Lisboa, Lisboa, Portugal., Aguiar P; NOVA National School of Public Health, Public Health Research Centre, Comprehensive Health Research Center, CHRC, NOVA University Lisbon, Lisboa, Portugal., Fernandes R; Instituto Politécnico de Setúbal, Escola Superior de Saúde, Setúbal, Portugal.; Comprehensive Health Research Centre, NOVA Medical School, Universidade Nova de Lisboa, Lisboa, Portugal.; LBMF, CIPER, Faculdade de Motricidade Humana, Universidade de Lisboa, Cruz-Quebrada, Dafundo, Portugal., Sousa RD; Comprehensive Health Research Centre, NOVA Medical School, Universidade Nova de Lisboa, Lisboa, Portugal., Cruz EB; Instituto Politécnico de Setúbal, Escola Superior de Saúde, Setúbal, Portugal.; Comprehensive Health Research Centre, NOVA Medical School, Universidade Nova de Lisboa, Lisboa, Portugal.
Jazyk: angličtina
Zdroj: BMC musculoskeletal disorders [BMC Musculoskelet Disord] 2024 Jun 05; Vol. 25 (1), pp. 440. Date of Electronic Publication: 2024 Jun 05.
DOI: 10.1186/s12891-024-07542-7
Abstrakt: Background: Low back pain (LBP) is a common health condition and the leading cause of years lived with disability worldwide. Most LBP episodes have a favourable prognosis, but recurrences within a year are common. Despite the individual and societal impact related to LBP recurrences, there is limited evidence on effective strategies for secondary prevention of LBP and successful implementation of intervention programmes in a real-world context. The aim of this study is to analyse the effectiveness of a tailored exercise and behavioural change programme (MyBack programme) in the secondary prevention of LBP; and evaluate acceptability, feasibility and determinants of implementation by the different stakeholders, as well as the implementation strategy of the MyBack programme in real context.
Methods: This protocol describes a hybrid type I, randomized controlled trial to evaluate the effectiveness and implementation of MyBack programme in the context of primary health care. The Behaviour Change Wheel framework and FITT-VP principles will inform the development of the behaviour change and exercise component of MyBack programme, respectively. Patients who have recently recovered from an episode of non-specific LBP will be randomly assigned to MyBack and usual care group or usual care group. The primary outcome will be the risk of LBP recurrence. The secondary outcomes will include disability, pain intensity, musculoskeletal health, and health-related quality of life. Participants will be followed monthly for 1 year. Costs data related to health care use and the MyBack programme will be also collected. Implementation outcomes will be assessed in parallel with the effectiveness study using qualitative methods (focus groups with participants and health providers) and quantitative data (study enrolment and participation data; participants adherence).
Discussion: To our knowledge, this is the first study assessing the effectiveness and implementation of a tailored exercise and behaviour change programme for prevention of LBP recurrences. Despite challenges related to hybrid design, it is expected that data on the effectiveness, cost-effectiveness, and implementation of the MyBack programme may contribute to improve health care in patients at risk of LBP recurrences, contributing to direct and indirect costs reduction for patients and the health system.
Trial Registration Number: NCT05841732.
(© 2024. The Author(s).)
Databáze: MEDLINE
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