Individually tailored self-management app-based intervention (selfBACK) versus a self-management web-based intervention (e-Help) or usual care in people with low back and neck pain referred to secondary care: protocol for a multiarm randomised clinical trial
Open Access
- 13 September 2021
- Vol. 11 (9), e047921
- https://doi.org/10.1136/bmjopen-2020-047921
Abstract
Introduction Low back pain (LBP) and neck pain (NP) are common and costly conditions. Self-management is a key element in the care of persistent LBP and NP. Artificial intelligence can be used to support and tailor self-management interventions, but their effectiveness needs to be ascertained. The aims of this trial are (1) to evaluate the effectiveness of an individually tailored app-based self-management intervention (selfBACK) adjunct to usual care in people with LBP and/or NP in secondary care compared with usual care only, and (2) to compare the effectiveness of selfBACK with a web-based self-management intervention without individual tailoring (e-Help). Methods and analysis This is a randomised, assessor-blind clinical trial with three parallel arms: (1) selfBACK app adjunct to usual care; (2) e-Help website adjunct to usual care and (3) usual care only. Patients referred to St Olavs Hospital, Trondheim (Norway) with LBP and/or NP and accepted for assessment/treatment at the multidisciplinary outpatient clinic for back or neck rehabilitation are invited to the study. Eligible and consenting participants are randomised to one of the three arms with equal allocation ratio. We aim to include 279 participants (93 in each arm). Outcome variables are assessed at baseline (before randomisation) and at 6-week, 3-month and 6-month follow-up. The primary outcome is musculoskeletal health measured by the Musculoskeletal Health Questionnaire at 3 months. A mixed-methods process evaluation will document patients’ and clinicians’ experiences with the interventions. A health economic evaluation will estimate the cost-effectiveness of both interventions’ adjunct to usual care. Ethics and dissemination The trial is approved by the Regional Committee for Medical and Health Research Ethics in Central Norway (Ref. 2019/64084). The results of the trial will be published in peer-review journals and presentations at national and international conferences relevant to this topic. Trial registration number NCT04463043.Funding Information
- Helse Midt-Norge (2019/34 -629/2020)
- European Union (689043, 777090)
This publication has 51 references indexed in Scilit:
- Measurement of acute nonspecific low back pain perception in primary care physical therapy: reliability and validity of the brief illness perception questionnaireBMC Musculoskeletal Disorders, 2013
- Critical factors in cut-out complication after gamma nail treatment of proximal femoral fracturesBMC Musculoskeletal Disorders, 2013
- The Reliability of a New Sleep Screening Questionnaire for Large Population-Based Studies: The Third Nord-Trøndelag Health StudyThe Open Sleep Journal, 2011
- The PHQ-8 as a measure of current depression in the general populationJournal of Affective Disorders, 2009
- Minimal Clinically Important Change of the Neck Disability Index and the Numerical Rating Scale for Patients With Neck PainSpine, 2007
- The pain self‐efficacy questionnaire: Taking pain into accountEuropean journal of pain, 2007
- Using thematic analysis in psychologyQualitative Research in Psychology, 2006
- A Fear-Avoidance Beliefs Questionnaire (FABQ) and the role of fear-avoidance beliefs in chronic low back pain and disabilityPain, 1993
- EuroQol - a new facility for the measurement of health-related quality of lifeHealth Policy, 1990
- A Study of the Natural History of Back PainSpine, 1983