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

Maria Augusta de Araújo Mota; Tarson Brito Landolfi; Marina Cardoso de Melo Silva; Bruna de Melo Santana; Angela Jornada Ben; Hanneke van Dongen; Judith E. Bosmans; Raymond Ostelo; Thomaz Nogueira Burke; Fernanda Pasinato; Caroline Ribeiro Tottoli; Rodrigo Luiz Carregaro

doi:10.1186/s12891-025-09118-5

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

Maria Augusta de Araújo Mota^*
, Tarson Brito Landolfi
, Marina Cardoso de Melo Silva
, Bruna de Melo Santana
, Angela Jornada Ben
, Hanneke van Dongen
, Judith E. Bosmans
, Raymond Ostelo
, Thomaz Nogueira Burke
, Fernanda Pasinato
, Caroline Ribeiro Tottoli
, Rodrigo Luiz Carregaro

^*Corresponding author for this work

Research output: Contribution to Journal › Article › Academic › peer-review

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).

Original language	English
Article number	814
Pages (from-to)	1-10
Number of pages	10
Journal	BMC musculoskeletal disorders
Volume	26
Issue number	1
Early online date	23 Aug 2025
DOIs	https://doi.org/10.1186/s12891-025-09118-5
Publication status	Published - 2025

Bibliographical note

Funding

The study is supported by the Research Support Foundation of the Federal District (FAPDF, protocol n. 00193–00002422/2023-68 and 00193-00000758/2021), National Council for Scientific and Technological Development (CNPq), process n. 302328/2023-8; Coordination for the Improvement of Higher Education Personnel (CAPES, funding code 001); and UnB/DPI. The funding sources were not involved in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; and in the decision to submit the article for publication.

Funders	Funder number
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior
Fundação de Apoio à Pesquisa do Distrito Federal	00193-00000758/2021, 00193–00002422/2023-68
Conselho Nacional de Desenvolvimento Científico e Tecnológico	302328/2023-8

Keywords

Humans
Low Back Pain/therapy
Cost-Benefit Analysis
Telemedicine/economics
Adult
Exercise Therapy/economics
Chronic Pain/therapy
Middle Aged
Multicenter Studies as Topic
Young Adult
Female
Male
Adolescent
Randomized Controlled Trials as Topic
Treatment Outcome

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de Araújo Mota, M. A., Landolfi, T. B., de Melo Silva, M. C., de Melo Santana, B., Jornada Ben, A., van Dongen, H., Bosmans, J. E., Ostelo, R., Burke, T. N., Pasinato, F., Ribeiro Tottoli, C., & Luiz Carregaro, R. (2025). A multicenter trial-based economic evaluation of a mobile health intervention for individuals with chronic non-specific low back pain: randomized controlled trial protocol. BMC musculoskeletal disorders, 26(1), 1-10. Article 814. https://doi.org/10.1186/s12891-025-09118-5

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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).",

keywords = "Humans, Low Back Pain/therapy, Cost-Benefit Analysis, Telemedicine/economics, Adult, Exercise Therapy/economics, Chronic Pain/therapy, Middle Aged, Multicenter Studies as Topic, Young Adult, Female, Male, Adolescent, Randomized Controlled Trials as Topic, Treatment Outcome",

author = "\{de Ara{\'u}jo Mota\}, \{Maria Augusta\} and Landolfi, \{Tarson Brito\} and \{de Melo Silva\}, \{Marina Cardoso\} and \{de Melo Santana\}, Bruna and \{Jornada Ben\}, Angela and \{van Dongen\}, Hanneke and Bosmans, \{Judith E.\} and Raymond Ostelo and Burke, \{Thomaz Nogueira\} and Fernanda Pasinato and \{Ribeiro Tottoli\}, Caroline and \{Luiz Carregaro\}, Rodrigo",

note = "{\textcopyright} 2025. The Author(s).",

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doi = "10.1186/s12891-025-09118-5",

language = "English",

volume = "26",

pages = "1--10",

journal = "BMC musculoskeletal disorders",

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de Araújo Mota, MA, Landolfi, TB, de Melo Silva, MC, de Melo Santana, B, Jornada Ben, A , van Dongen, H , Bosmans, JE , Ostelo, R, Burke, TN, Pasinato, F, Ribeiro Tottoli, C & Luiz Carregaro, R 2025, 'A multicenter trial-based economic evaluation of a mobile health intervention for individuals with chronic non-specific low back pain: randomized controlled trial protocol', BMC musculoskeletal disorders, vol. 26, no. 1, 814, pp. 1-10. https://doi.org/10.1186/s12891-025-09118-5

A multicenter trial-based economic evaluation of a mobile health intervention for individuals with chronic non-specific low back pain: randomized controlled trial protocol. / de Araújo Mota, Maria Augusta; Landolfi, Tarson Brito; de Melo Silva, Marina Cardoso et al.
In: BMC musculoskeletal disorders, Vol. 26, No. 1, 814, 2025, p. 1-10.

Research output: Contribution to Journal › Article › Academic › peer-review

TY - JOUR

T1 - A multicenter trial-based economic evaluation of a mobile health intervention for individuals with chronic non-specific low back pain

T2 - randomized controlled trial protocol

AU - de Araújo Mota, Maria Augusta

AU - Landolfi, Tarson Brito

AU - de Melo Silva, Marina Cardoso

AU - de Melo Santana, Bruna

AU - Jornada Ben, Angela

AU - van Dongen, Hanneke

AU - Bosmans, Judith E.

AU - Ostelo, Raymond

AU - Burke, Thomaz Nogueira

AU - Pasinato, Fernanda

AU - Ribeiro Tottoli, Caroline

AU - Luiz Carregaro, Rodrigo

PY - 2025

Y1 - 2025

N2 - 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).

AB - 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).

KW - Humans

KW - Low Back Pain/therapy

KW - Cost-Benefit Analysis

KW - Telemedicine/economics

KW - Adult

KW - Exercise Therapy/economics

KW - Chronic Pain/therapy

KW - Middle Aged

KW - Multicenter Studies as Topic

KW - Young Adult

KW - Female

KW - Male

KW - Adolescent

KW - Randomized Controlled Trials as Topic

KW - Treatment Outcome

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UR - https://www.scopus.com/pages/publications/105013984366#tab=citedBy

U2 - 10.1186/s12891-025-09118-5

DO - 10.1186/s12891-025-09118-5

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SN - 1471-2474

VL - 26

SP - 1

EP - 10

JO - BMC musculoskeletal disorders

JF - BMC musculoskeletal disorders

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de Araújo Mota MA, Landolfi TB, de Melo Silva MC, de Melo Santana B, Jornada Ben A , van Dongen H et al. A multicenter trial-based economic evaluation of a mobile health intervention for individuals with chronic non-specific low back pain: randomized controlled trial protocol. BMC musculoskeletal disorders. 2025;26(1):1-10. 814. Epub 2025 Aug 23. doi: 10.1186/s12891-025-09118-5

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

Abstract

Bibliographical note

Funding

Keywords

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