Effectiveness of an app-delivered self-management program for people with low back pain - a protocol for the selfBACK randomised controlled trial

Sandal, L. F. et al. (2019) Effectiveness of an app-delivered self-management program for people with low back pain - a protocol for the selfBACK randomised controlled trial. JMIR Research Protocols, (doi: 10.2196/14720) (Early Online Publication)

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Background: Low back pain (LBP) is prevalent across all social classes, in all age groups and across industrialised as well as developing countries. From a global perspective LBP is considered the leading cause of disability and it negatively impacts everyday life and wellbeing. Self-management is a recommended first-line treatment and mobile applications (apps) are a promising platform to support self-management of conditions like LBP. In the selfBACK project, we have developed a digital decision support system that is made available for the user via an app and that is intended to support tailored self-management of non-specific LBP. Objective: The trial aims to evaluate the effectiveness of using the selfBACK app to support self-management in addition to usual care (intervention group) versus usual care only (control group) in people with non-specific LBP. Methods: Single-blinded, randomised controlled trial (RCT) with two parallel arms. The selfBACK app provides tailored self-management plans consisting of advice on physical activity, physical exercises and educational content. Tailoring of plans is achieved by using the case-based reasoning (CBR) methodology, which is a branch of artificial intelligence. The core of the CBR methodology is to use data about the current case (participant) along with knowledge about previous and similar cases to tailor the self-management plan to the current case. This enables a person-centred intervention based on what has – and has not been – successful in previous cases. Participants in the RCT are people with LBP, who consulted a health-care professional in primary care within the preceding eight weeks. Participants are randomised to using the selfBACK app in addition to usual care versus usual care only. We aim to include a total of 350 participants; 175 participants in each arm. Outcomes are collected at baseline, six weeks and three, six and nine months. The primary endpoint is difference in pain-related disability between the intervention group and the control group, assessed by the Roland-Morris Disability Questionnaire at three months. Results: The trial opened for recruitment in February 2019. The first results are expected to be published in summer of 2020. Conclusions: This RCT will provide insights regarding the benefits of supporting tailored self-management of LBP through an app which is ubiquitous and available at times convenient for the user. If successful, the intervention has the potential to become a model for the provision of tailored self-management support to people with non-specific LBP and to inform future interventions for other painful, musculoskeletal conditions. Clinical Trial: NCT03798288.

Item Type:Articles
Status:Early Online Publication
Glasgow Author(s) Enlighten ID:Nicholl, Dr Barbara and Mair, Professor Frances and Wood, Miss Karen
Authors: Sandal, L. F., Stochkendahl, M. J., Svendsen, M. J., Wood, K., Øverås, C. K., Nordstoga, A. L., Villumsen, M., Rasmussen, C. D. N., Nicholl, B., Cooper, K., Kjaer, P., Mair, F. S., Sjøgaard, G., Nilsen, T. I. L., Hartvigsen, J., Bach, K., Mork, P. J., and Søgaard, K.
College/School:College of Medical Veterinary and Life Sciences > Institute of Health and Wellbeing > General Practice and Primary Care
Journal Name:JMIR Research Protocols
Publisher:JMIR Publications
ISSN (Online):1929-0748
Published Online:18 May 2019
Copyright Holders:Copyright © 2019 The Authors
First Published:First published in JMIR Research Protocols 2019
Publisher Policy:Reproduced under a Creative Commons License

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Project CodeAward NoProject NamePrincipal InvestigatorFunder's NameFunder RefLead Dept
172430SELFBACKBarbara NichollEuropean Commission (EC)689043HW - General Practice and Primary Care