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
| Autor: | Gro F. Bertheussen, Solveig Osborg Ose, Lene Aasdahl, Silje Lill Kaspersen, Anne Lovise Nordstoga, Gunn Hege Marchand, Nora Østbø Boldermo, Kerstin Bach, Else-Norun Kvarner, Sigmund Østgård Gismervik, Tom Ivar Lund Nilsen, Janne-Birgitte Bloch Børke, Paul Jarle Mork, Ilya Ashikhmin, Ellen Marie Bardal, Anna Marcuzzi |
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| Rok vydání: | 2021 |
| Předmět: |
medicine.medical_specialty
medicine.medical_treatment Cost-Benefit Analysis Psychological intervention back pain Secondary Care Rehabilitation Medicine 03 medical and health sciences 0302 clinical medicine Artificial Intelligence Back pain Medicine Outpatient clinic Humans 030212 general & internal medicine Randomized Controlled Trials as Topic Neck pain Rehabilitation Self-management Neck Pain business.industry Self-Management General Medicine Low back pain Mobile Applications 3. Good health Clinical trial pain management Physical therapy Quality of Life medicine.symptom musculoskeletal disorders business 030217 neurology & neurosurgery Internet-Based Intervention |
| Zdroj: | BMJ Open BMJ Open, Vol 11, Iss 9 (2021) |
| ISSN: | 2044-6055 |
| DOI: | 10.1136/bmjopen-2020-047921 |
| Popis: | IntroductionLow 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 analysisThis 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 disseminationThe 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 numberNCT04463043. |
| Databáze: | OpenAIRE |
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