Personalized mobile app program versus conventional exercise booklet for 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)

This trial will test whether a supervised, personalized mobile app program helps adults with chronic low back pain more than usual exercise instructions and whether it is more cost-effective.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 146 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: University of Brasilia (other)
• Locations: 2 sites (Ceilândia, Federal District and 1 other locations)
• Trial ID: NCT06651099 on ClinicalTrials.gov

What this trial studies

This multicentre randomized trial compares a supervised, personalized mHealth intervention delivered via smartphone with conventional exercise therapy provided through a booklet, alongside a trial-based economic evaluation. Adults aged 18–65 with self-reported low back pain for more than 12 weeks and pain ≥4 on the NRS are randomized using permuted blocks and followed at five time points over 12 months. The primary clinical outcome is disability measured by the Roland-Morris Disability Questionnaire, with secondary outcomes including pain (NRS), health utility (EQ-5D-5L), fear-avoidance (FABQ), self-efficacy (PSEQ), and global perceived effect. The study plans to enroll 146 participants across two physical therapy rehabilitation clinics and will compare both clinical outcomes and costs between groups.

Who should consider this trial

Good fit: Adults 18–65 with chronic non-specific low back pain lasting more than 12 weeks, pain intensity ≥4, no physiotherapy for LBP in the past 6 months, a smartphone with internet access, and a Patient Activation Measure level of 2 or higher are ideal candidates.

Not a fit: People with red flags or neurological impairment, prior spinal surgery, diagnosed spinal osteoarthritis, fibromyalgia or rheumatic disease, referred visceral pain, pregnancy, or who lack a smartphone or sufficient self-management activation are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, the app could offer a more accessible, personalized way to reduce disability and pain while lowering treatment costs.

How similar studies have performed: Previous mHealth programs for chronic low back pain have produced mixed results, with some positive clinical findings but inconsistent evidence on cost-effectiveness.

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.

Where this trial is running

Ceilândia, Federal District and 1 other locations

• Universidade de Brasília — Ceilândia, Federal District, Brazil (RECRUITING)
• Federal University of Mato Grosso do Sul — Campo Grande, Mato Grosso do Sul, Brazil (RECRUITING)

Study contacts

• Study coordinator: Maria Augusta A Mota, MS

Conditions: Low Back Pain, Back pain, Mobile health, Economic evaluation, Exercise therapy, Self-management