NCT06651099

Trial-based Economic Evaluation of a Mobile Health Intervention for Individuals With Chronic Non-specific Low Back Pain

A Multicenter Trial-based Economic Evaluation of a Mobile Health Intervention for Individuals With Chronic Non-specific Low Back Pain: Randomized Controlled Trial (eBack Trial)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 146 (estimated)
• Sponsor: University of Brasilia · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The aim of this trial is to assess the effectiveness and cost-effectiveness of a supervised and more personalised mhealth intervention compared with conventional exercise therapy in people with chronic non-specific low back pain.

Detailed 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 (EQ5D5L), fears and beliefs (FABQ), self-efficacy (PSEQ), and global perceived effect. A sample size of 146 participants was estimated (73 allocated to each group) in order 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.

Conditions

• Low Back Pain

Interventions

Type	Name	Description
OTHER	mhealth application	Individuals enrolled in the mhealth intervention will receive tailored content will include exercises focused on mobility, flexibility, core stabilization, and strengthening. Additionally, the mobile application will provide educational material on pain and health, covering topics such as the neurophysiology of pain, the multidimensional nature of low back pain, myths and facts about the condition, the importance of sleep, and stress management, which will include relaxation techniques and mindfulness. All content will be evidence-based, using clinical guidelines, systematic reviews and other high-quality studies to support inclusion in the mobile application. The intervention will be supervised by a physiotherapist, remotely via messaging or telephone calls.
OTHER	Conventional exercise therapy	Participants in this intervention will receive a printed booklet containing a description and recommendations for carrying out an exercise program at home, which will be characterized by general exercises (such as strengthening, mobilization). The intervention will be supervised by a physiotherapist, remotely via messaging or telephone calls.

Timeline

• Start date: 2025-11-15
• Primary completion: 2026-10-30
• Completion: 2027-01-20
• First posted: 2024-10-21
• Last updated: 2026-03-24

Locations

2 sites across 1 country: Brazil