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

NCT06651099 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 146

Last updated 2026-03-24

No results posted yet for this study

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.

Conditions

  • Low Back Pain

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 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.

Sponsors & Collaborators

  • VU University of Amsterdam

    collaborator OTHER

  • Federal University of Mato Grosso

    collaborator OTHER

  • University of Brasilia

    lead OTHER

Principal Investigators

  • Rodrigo L Carregaro, PhD · University of Brasilia

  • Fernanda Pasinato, PhD · University of Brasilia

  • Thomaz N Burke, PhD · Federal University of Mato Grosso

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-15
Primary Completion
2026-10-30
Completion
2027-01-20

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06651099 on ClinicalTrials.gov