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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

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. Keywords: back pain; musculoskeletal disorders; pain management.

Trial
Journal Ref. https://pubmed.ncbi.nlm.nih.gov/34518253/
Intervention Other - ADD-ON INTERVENTIONS TO A SPECIALIST CARE WAITING LIST: Usual care Participants randomised to usual care will continue to follow any diagnostic or treatment-related pathways as indicated by healthcare practitioners they may consult during the study period. All patients will eventually undergo a clinical examination at first consultation at the outpatient clinic. Based on this first consultation, a suitable treatment is offered to the patient at the clinicians’ discretion in accordance with current evidence-based guidelines. Treatment options include: no further treatment, adjusted recommendations for primary care treatment, outpatient multimodal rehabilitation, surgery and referral to other medical specialists (eg, orthopaedic, neurosurgery, neurology or rheumatology department). Therefore, the type, modality and length of treatment are expected to vary between patients. The SELFBACK app adjunct to usual care In addition to usual care, participants in this group will have access to the SELFBACK intervention throughout the study period.The SELFBACK app provides self-management tailored by a artificial intelligence algorithm. On a weekly basis, tailoring questions are asked via the app and used to revise the self-management plan for the upcoming week. The weekly plans generated encompass three main components: (1) advice on physical activity based on step counting, (2) educational messages based on a cognitive–behavioural approach, and (3) recommendations on strength and flexibility exercises. Additional resources, such as general information about low back pain / neck pain, mindfulness audios, goal-setting tool and pain relief exercises, are also available in the app. The e-Help website adjunct to usual care In addition to usual care, participants randomised to this group will have access to the e-Help intervention. The e-Help is a web-based resource based on the SELFBACK theoretical framework and content.The e-Help website involved no individual tailoring of the content but instructions in the first section emphasise self-tailoring techniques based on pacing and goal-setting strategies.
Number of sites 1
Countries involved Norway
Sample size 294
Type of statistical analyses
Duration of trial
Primary outcome The primary outcome is musculoskeletal health measured by the Musculoskeletal Health Questionnaire at 3 months
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Scores:

(shows median if more than one score was entered)

Elig. Recr. Setting Org. Int. Flex. Del. Flex. Adherence Follow-Up Prim. Out. Prim. An.
5 4 5 4 5 5 3 3 5

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