391: Multicenter trial of mHealth versus booklet for chronic low back pain: Preliminary results

Topic: Clinical Science
Subtopic: Pain category (ICD-11), Chronic primary musculoskeletal pain, Digital Health Technologies

Background and Aims: Chronic non-specific low back pain (CNLBP) is a leading cause of disability worldwide, generating a substantial clinical and economic burden. Digital health strategies could improve the scalability and personalisation of exercise-based interventions by integrating pain education and neurocognitive approaches. This study presents preliminary findings from an ongoing multicentre randomised controlled trial with an economic evaluation, which compares a supervised mobile health intervention with a conventional exercise booklet. The objective was to explore the short-term (8-week) effects on pain and disability, and to examine whether prognostic risk factors at baseline influence the early response to treatment.

Methods: Adults aged 18–59y with CNLBP (>12 weeks; NRS≥4), smartphone/internet access, and Patient Activation Measure (PAM) ≥2, were recruited from two rehabilitation clinics in Brasília and Campo Grande, Brazil. Participants were randomised in a 1:1 ratio using concealed, centre-stratified permuted blocks, either to a supervised, tailored mHealth programme or to an exercise booklet. Both interventions occurred twice weekly for eight weeks. The mHealth group received app-delivered exercises and educational content, as well as physiotherapist supervision (two face-to-face sessions in week 1 and one in week 4, with remote monitoring). Outcomes were collected at baseline and eight weeks post-intervention.

Results: Preliminary data (n:19) showed mean improvements in both groups after eight weeks. Pain decreased from 5.9 (±1.7) to 3.1 (±1.9) in the booklet group, and from 6.3 (±1.2) to 2.7 (± 2.4) in the mhealth group. No significant time-by-group interaction or main group effect was observed for pain. Disability also improved in both groups, with no significant interaction or group effect. However, a significant time-by-baseline risk interaction was identified for disability, suggesting that prognostic classification may influence short-term response patterns. Effect sizes ranged from small to moderate across models.

Conclusions: These preliminary results indicate short-term improvements in disability (the primary outcome) and pain from baseline to 8 weeks. However, the superiority of the supervised mHealth programme over the booklet-delivered exercise programme remains uncertain in this underpowered interim sample. The observed time-by-baseline prognostic risk interaction should be treated as exploratory and hypothesis-generating, and requires confirmation in the full trial. Ongoing recruitment and protocol-defined follow-up assessments over 12 months will improve precision, enable more reliable estimation of the effect size, and clarify whether treatment response differs according to prognostic risk. A trial-based cost-effectiveness evaluation is planned alongside the effectiveness analyses.

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Presenting Author: Maria Augusta de Araújo Mota
Submitting Author: Maria Augusta de Araújo Mota

Senior Author: Rodrigo Luiz Carregaro

IASP 2026 Global Year theme of Neuropathic Pain: Yes

• Marina Cardoso de Melo: Postgraduate Studies - University of Brasília (UnB)
• Milena Gonçalves Cruz Miranda: Postgraduate Studies - University of Brasília (UnB)
• Yandra Júlia Silva Rocha: Postgraduate Studies - University of Brasília (UnB)
• Fernanda Pasinato: Postgraduate Studies - University of Brasília (UnB)
• Thomas Nogueira Burke: Postgraduate Studies - Federal University of Mato Grosso do Sul (UFMS)
• Yara Andrade Marques: Postgraduate Studies - University of Brasília (UnB)
• Aline Martins de Toledo: Postgraduate Studies - University of Brasília (UnB)
• Ângela Jordana Ben: Postgraduate Studies - Faculty of Science - Vrije Universiteit Amsterdam
• Judith E. Bosmans: Postgraduate Studies - Faculty of Science - Vrije Universiteit Amsterdam
• Raymond Ostelo: Postgraduate Studies - Faculty of Science - Vrije Universiteit Amsterdam
• Caroline Ribeiro Tottoli: University of Brasília (UnB) - University of Brasília (UnB)
• Rodrigo Luiz Carregaro: Postgraduate Studies - University of Brasília (UnB)