An App-Delivered Self-Management Program for People With Low Back Pain: Protocol for the selfBACK Randomized Controlled Trial

JMIR Research Protocols - Tập 8 Số 12 - Trang e14720
Louise Fleng Sandal1, Mette Jensen Stochkendahl1,2, Malene Jagd Svendsen1,3, Karen Wood4, Cecilie K. Øverås5,1, Anne Lovise Nordstoga5, Morten Villumsen5, Charlotte Diana Nørregaard Rasmussen3, Barbara I. Nicholl4, Kay Cooper6, Per Kjær1, Frances S Mair4, Gisela Sjøgaard1, Tom Ivar Lund Nilsen5, Jan Hartvigsen1,2, Kerstin Bach7, Paul Jarle Mork5, Karen Søgaard1
1Department of Sport Science and Clinical Biomechanics, University of Southern Denmark, Odense, Denmark
2Nordic Institute of Chiropractic and Clinical Biomechanics, Odense, Denmark
3National Research Centre for the Working Environment, Copenhagen, Denmark
4Institute of Health and Wellbeing, University of Glasgow, Glasgow, United Kingdom
5Department of Public Health and Nursing, Norwegian University of Science and Technology, Trondheim, Norway
6School of Health Sciences, Robert Gordon University, Aberdeen, United Kingdom
7Department of Computer Science, Norwegian University of Science and Technology, Trondheim, Norway

Tóm tắt

Background Low back pain (LBP) is prevalent across all social classes, in all age groups, and across industrialized and developing countries. From a global perspective, LBP is considered the leading cause of disability and negatively impacts everyday life and well-being. Self-management is a recommended first-line treatment, and mobile 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 made available for the user via an app intended to support tailored self-management of nonspecific 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 nonspecific LBP. Methods This is a single-blinded, randomized 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 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-centered 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 8 weeks. Participants are randomized 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, 6 weeks, and 3, 6, and 9 months. The primary end point is difference in pain-related disability between the intervention group and the control group assessed by the Roland-Morris Disability Questionnaire at 3 months. Results The trial opened for recruitment in February 2019. Data collection is expected to be complete by fall 2020, and the results for the primary outcome are expected to be published in fall 2020. Conclusions This RCT will provide insights regarding the benefits of supporting tailored self-management of LBP through an app 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 nonspecific LBP and inform future interventions for other painful musculoskeletal conditions. Trial Registration ClinicalTrial.gov NCT03798288; https://clinicaltrials.gov/ct2/show/NCT03798288 International Registered Report Identifier (IRRID) DERR1-10.2196/14720

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Tài liệu tham khảo

10.1016/S0140-6736(17)32154-2

10.1016/j.berh.2013.10.007

10.1177/101053950301500202

Maniadakis, N, 2000, Pain, 84, 95, 10.1016/S0304-3959(99)00187-6

10.1016/S0140-6736(18)30480-X

10.1007/s00586-017-5099-2

10.1016/j.jbspin.2011.03.019

Savigny, P, 2009, BMJ, 338, b1805, 10.1136/bmj.b1805

10.7326/M16-2367

Bernstein, IA, 2017, BMJ, 356, i6748, 10.1136/bmj.i6748

Barlow, J, 2002, Patient Educ Couns, 48, 177, 10.1016/S0738-3991(02)00032-0

Lorig, KR, 2003, Ann Behav Med, 26, 1, 10.1207/S15324796ABM2601_01

10.1002/acr.21737

10.1016/j.pec.2016.07.029

10.2196/rehab.9032

10.1080/09638280701189895

10.2196/jmir.5692

10.1016/j.cpr.2013.03.004

Hayden, JA, 2005, Ann Intern Med, 142, 776, 10.7326/0003-4819-142-9-200505030-00014

10.1186/s12911-016-0359-3

10.1016/j.berh.2017.04.002

10.2196/jmir.7290

10.2196/resprot.9379

Chan, A, 2013, BMJ, 346, e7586, 10.1136/bmj.e7586

Eysenbach, G, 2013, Stud Health Technol Inform, 192, 657

10.1016/j.cmpb.2017.05.010

10.1089/dia.2015.0413

Bartholomew, LK, 1998, Health Educ Behav, 25, 545, 10.1177/109019819802500502

Roland, M, 1983, Spine (Phila Pa 1976), 8, 145, 10.1097/00007632-198303000-00005

Roland, M, 1983, Spine (Phila Pa 1976), 8, 141, 10.1097/00007632-198303000-00004

Roland, M, 2000, Spine (Phila Pa 1976), 25, 3115, 10.1097/00007632-200012150-00006

10.1016/j.jclinepi.2005.03.018

Stratford, PW, 1994, Phys Ther, 74, 528, 10.1093/ptj/74.6.528

10.1093/ije/dys095

Waddell, G, 1993, Pain, 52, 157, 10.1016/0304-3959(93)90127-B

10.1016/j.ejpain.2005.12.008

Ahlstrom, L, 2010, Scand J Work Environ Health, 36, 404, 10.5271/sjweh.2917

10.1111/sms.12611

10.2519/jospt.2012.3953

10.2174/1874620901104010014

Cohen, S, 1983, J Health Soc Behav, 24, 385, 10.2307/2136404

Brooks, R, 1996, Health Policy, 37, 53, 10.1016/0168-8510(96)00822-6

10.1186/1471-2474-14-53

10.1016/j.jad.2008.06.026

Swinkels-Meewisse, EJCM, 2003, Man Ther, 8, 29, 10.1054/math.2002.0484

10.1002/acr.20543

10.1016/j.jval.2014.07.001

10.1016/S0140-6736(11)60937-9

10.1186/s12891-015-0787-8

10.1503/cmaj.111271

10.1155/2014/106102

10.1007/s00586-006-0128-6

Fitzmaurice, G, 2004, Applied Longitudinal Analysis, 187

10.1136/bmj.e5840

10.1186/1471-2288-12-35

10.1016/j.jclinepi.2013.11.011

10.2196/jmir.6714

10.1177/0038038509103208

10.1186/s13012-018-0758-1

RE-AIM2019-09-23http://www.re-aim.org

10.1186/1745-6215-11-32

10.1016/j.spinee.2017.04.008

10.1038/s41746-018-0076-7

10.1038/s41746-019-0109-x

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JMIR Research Protocols

Tập 8 Số 12

e14720

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