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September 10, 2025Open Access

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

MMMaria Augusta de Araújo MotaUniversidade de Brasília TLTarson Brito LandolfiUniversidade Federal de Mato Grosso do Sul MSMarina Cardoso de Melo SilvaUniversidade de Brasília

Key Points

This trial investigates the cost-effectiveness of mobile health interventions for chronic non-specific low back pain, aiming to improve outcomes.
Participants include adults aged 18-59 with chronic lower back pain for over 12 weeks, with outcomes measured at multiple time points.
The study employs a randomized controlled trial design, comparing a mobile health intervention to conventional exercise therapy.
Findings may highlight the effectiveness of tailored care strategies in mobile health applications for managing chronic pain.

Abstract

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. 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. 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. NCT06651099 (registration date 21/10/2024).

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