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A multicenter trial-based economic evaluation of a mobile health intervention for individuals with chronic non-specific low back pain: randomized controlled trial protocol: randomized controlled trial protocol

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Title: A multicenter trial-based economic evaluation of a mobile health intervention for individuals with chronic non-specific low back pain: randomized controlled trial protocol: randomized controlled trial protocol
Authors: de Araújo Mota, Maria Augusta, Landolfi, Tarson Brito, de Melo Silva, Marina Cardoso, de Melo Santana, Bruna, Ben, Ângela Jornada, van Dongen, Johanna M., Bosmans, Judith E., Ostelo, Raymond, Burke, Thomaz Nogueira, Pasinato, Fernanda, Tottoli, Caroline R., Luiz Carregaro, Rodrigo
Source: BMC Musculoskeletal Disorders. 26
Publisher Information: Springer Science and Business Media LLC, 2025.
Publication Year: 2025
Subject Terms: Adult, Male, Adolescent, Chronic Pain/therapy, Cost-Benefit Analysis, Exercise Therapy/economics, Back pain, Exercise therapy, Middle Aged, Economic evaluation, Young Adult, Treatment Outcome, Low Back Pain/therapy, Self-management, Humans, Telemedicine/economics, Multicenter Studies as Topic, Female, Digital health, Randomized Controlled Trials as Topic
Description: BACKGROUND: Chronic non-specific low back pain (CNLBP) is a prevalent and costly condition that encourages research into self-management strategies. Mobile health (mhealth) applications are promising interventions, but current evidence on their effectiveness is still conflicting. The aim is to investigate the (cost-)effectiveness of a supervised and personalized mhealth intervention, compared with conventional exercise therapy in individuals with CNLBP.METHODS: A multicentre trial-based economic evaluation was designed to compare a mhealth intervention with conventional exercise. Participants will be recruited from two physical therapy rehabilitation clinics located within the participating centres. Adults aged between 18 and 59 years and with self-reported LBP > 12 weeks will be included. Following the collection of baseline data, participants will be randomly assigned to one of two groups using a permuted block randomization: (1) mhealth; (2) Conventional exercise delivered through a booklet. Outcome assessments will be conducted following randomisation at five distinct time points, resulting in a total follow-up period of 12 months. The primary clinical outcome is disability (Roland-Morris Disability Questionnaire), while secondary outcomes include pain (NRS), utility (Eq. 5D5L), fears and beliefs (FABQ), self-efficacy (PSEQ), and global perceived effect. A sample size of 146 participants was estimated (73 allocated to each group) to detect a 2-point between-groups difference on disability. A cost-effectiveness study will be conducted alongside the trial, comparing the two interventions in terms of costs and clinical outcomes.DISCUSSION: While mhealth applications show promise as interventions for people with LBP, there is still a gap regarding the type of delivery and personalisation strategies. This study investigates whether the implementation of stratified and tailored care within a mobile application, based on patient-reported outcome measures and supervised by a physiotherapist, is (cost-)effective.TRIAL REGISTRATION: NCT06651099 (registration date 21/10/2024).
Document Type: Article
Language: English
ISSN: 1471-2474
DOI: 10.1186/s12891-025-09118-5
Rights: CC BY NC ND
Accession Number: edsair.doi.dedup.....e58f5cd93f45777aacfb07cd2f56dd2e
Database: OpenAIRE
Description
Abstract:BACKGROUND: Chronic non-specific low back pain (CNLBP) is a prevalent and costly condition that encourages research into self-management strategies. Mobile health (mhealth) applications are promising interventions, but current evidence on their effectiveness is still conflicting. The aim is to investigate the (cost-)effectiveness of a supervised and personalized mhealth intervention, compared with conventional exercise therapy in individuals with CNLBP.METHODS: A multicentre trial-based economic evaluation was designed to compare a mhealth intervention with conventional exercise. Participants will be recruited from two physical therapy rehabilitation clinics located within the participating centres. Adults aged between 18 and 59 years and with self-reported LBP > 12 weeks will be included. Following the collection of baseline data, participants will be randomly assigned to one of two groups using a permuted block randomization: (1) mhealth; (2) Conventional exercise delivered through a booklet. Outcome assessments will be conducted following randomisation at five distinct time points, resulting in a total follow-up period of 12 months. The primary clinical outcome is disability (Roland-Morris Disability Questionnaire), while secondary outcomes include pain (NRS), utility (Eq. 5D5L), fears and beliefs (FABQ), self-efficacy (PSEQ), and global perceived effect. A sample size of 146 participants was estimated (73 allocated to each group) to detect a 2-point between-groups difference on disability. A cost-effectiveness study will be conducted alongside the trial, comparing the two interventions in terms of costs and clinical outcomes.DISCUSSION: While mhealth applications show promise as interventions for people with LBP, there is still a gap regarding the type of delivery and personalisation strategies. This study investigates whether the implementation of stratified and tailored care within a mobile application, based on patient-reported outcome measures and supervised by a physiotherapist, is (cost-)effective.TRIAL REGISTRATION: NCT06651099 (registration date 21/10/2024).
ISSN:14712474
DOI:10.1186/s12891-025-09118-5