Trial-based Economic Evaluation of a Mobile Health Intervention for Individuals With Chronic Non-specific Low Back Pain
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: mhealth application, Conventional exercise therapy.
- Who it may be relevant to
- Registry conditions: Low Back Pain. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Brazil
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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)
Overview
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.
Interventions
- 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 mindf - 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.
Primary outcome measures
- Disability score as assessed by the Roland-Morris Disability Questionnaire [Time frame: From enrollment to the end of treatment (around eight to ten weeks from baseline), and follow-up moments: follow-up 1 (26 weeks after baseline); follow-up 2 (39 weeks after baseline), and follow-up 3 (52 weeks after baseline)]
Secondary outcome measures (5)
- Pain intensity as measured using the Numerical Rating Scale (NRS) [Time frame: From enrollment to the end of treatment (around eight to ten weeks from baseline), and follow-up moments: follow-up 1 (26 weeks after baseline); follow-up 2 (39 weeks after baseline), and follow-up 3 (52 weeks after baseline)]
- Health-related quality of life (Utility) as measured by the EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) questionnaire [Time frame: From enrollment to the end of treatment (around eight to ten weeks from baseline), and follow-up moments: follow-up 1 (26 weeks after baseline); follow-up 2 (39 weeks after baseline), and follow-up 3 (52 weeks after baseline)]
- Fear and beliefs as measured by the Fear Avoidance Beliefs Questionnaire [Time frame: From enrollment to the end of treatment (around eight to ten weeks from baseline), and follow-up moments: follow-up 1 (26 weeks after baseline); follow-up 2 (39 weeks after baseline), and follow-up 3 (52 weeks after baseline)]
- Self-efficacy as measured by the Self-Efficacy Questionnaire (PSEQ) [Time frame: From enrollment to the end of treatment (around eight to ten weeks from baseline), and follow-up moments: follow-up 1 (26 weeks after baseline); follow-up 2 (39 weeks after baseline), and follow-up 3 (52 weeks after baseline)]
- Perceived recovery as measured by the Global Perceived Effect Scale [Time frame: At the end of treatment (around eight to ten weeks from baseline), and follow-up moments: follow-up 1 (26 weeks after baseline); follow-up 2 (39 weeks after baseline), and follow-up 3 (52 weeks after baseline)]
Eligibility criteria
Inclusion criteria
- Adults aged between 18 and 65 years;
- Self-reported low back pain for more than 12 consecutive weeks prior to the study, with pain intensity ≥4 in the numerical rating scale (NRS);
- Not having participated in physiotherapy sessions for treatment of low back pain for at least 6 months prior to the start of the study;
- Having a smartphone with internet access;
- Self-management activation classified as Level 2 or higher (i.e., classifications of low, medium and high knowledge about self-management), according to the Patient Activation Measure (PAM) questionnaire.
Exclusion criteria
- History of spinal trauma or fracture;
- Diagnosis of spinal osteoarthritis, fibromyalgia, or rheumatic diseases; 3) Referred pain (from viscera, appendicitis, abdominal and pelvic pain);
- Previous spinal surgery;
- Presence of red flags, signs and/or symptoms of neurological impairment;
- Pregnancy.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Brazil · 2 centers
- Universidade de Brasília — Ceilândia
- Federal University of Mato Grosso do Sul — Campo Grande
Publications
- de Araujo Mota MA, Landolfi TB, de Melo Silva MC, de Melo Santana B, Ben AJ, van Dongen JM, Bosmans JE, Ostelo R, Burke TN, Pasinato F, Tottoli CR, Luiz Carregaro R. 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 Musculoskelet Disord. 2025 Aug 23;26(1):814. doi: 10.1186 PMID 40849470
Identifiers
NCT: NCT06651099 · 6.674.643