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

NCT06651099 | Recruiting

• 1 other identifier: 6.674.643
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Back pain; Mobile health; Economic evaluation; Exercise therapy; Self-management

Outcome Measures

Primary Outcomes (1)

• Disability score as assessed by the Roland-Morris Disability Questionnaire

  Disability will be the primary clinical outcome and will be measured using the Brazilian-portuguese validated version of the Roland-Morris Disability Questionnaire (RMDQ). The questionnaire consists of 24 items with 0=no and 1=yes, and the total score ranges from zero (no disability) to 24 (severe disability).

  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 Outcomes (5)

• Pain intensity as measured using the Numerical Rating Scale (NRS)

  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

  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

  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)

  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

  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)

Other Outcomes (2)

• Quality-adjusted life years (QALY)

  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)

• Cost-effectiveness

  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)

Study Arms (2)

mhealth application (experimental group)

EXPERIMENTAL

The mhealth intervention group will be instructed to perform the exercises twice a week for 8 weeks, lasting approximately 30 minutes per session. Participants will be instructed to watch the health education content (e.g., short videos, infographics) and exercise videos provided by the app, and to take breaks during each session. Guidance will be provided during the intervention and weekly monitoring by a physiotherapist by messaging or telephone calls. In the first week of the intervention there will be two face-to-face sessions supervised by the physiotherapist to familiarize the participants with the mobile application and provide instructions on the intervention. A further face-to-face session will take place half-way the intervention, to monitor the participants.

Other: mhealth application

Conventional booklet exercise (comparator group)

ACTIVE COMPARATOR

After the assessment, all participants will receive a printed booklet containing a description and recommendations for carrying out the exercise program at home, which will be characterized by general exercises (i.e., strengthening, mobilization). The individuals will be instructed to perform the exercises twice a week for 8 weeks, following the same duration on the experimental group. Participants will be monitored and supervised by another physiotherapist via messaging app or telephone calls, following the same procedures reported in the experimental group. In the first week of the intervention there will be two face-to-face sessions supervised by a physiotherapist to familiarize the participants with the exercises and explain the booklet, and provide instructions on the intervention. A further face-to-face session will take place half-way the intervention, to monitor the participants.

Other: Conventional exercise therapy

Interventions

mhealth application OTHER

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.

mhealth application (experimental group)

Conventional exercise therapy OTHER

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.

Conventional booklet exercise (comparator group)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Brasilia: lead
• VU University of Amsterdam: collaborator
• Federal University of Mato Grosso: collaborator

Study Sites (2)

Universidade de Brasília

Ceilândia, Federal District, 72220-275, Brazil

RECRUITING

Federal University of Mato Grosso do Sul

Campo Grande, Mato Grosso do Sul, 79070-900, Brazil

RECRUITING

Related Publications (1)

• 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/s12891-025-09118-5.

  PMID: 40849470 DERIVED

MeSH Terms

Conditions

Low Back Pain; Back Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Rodrigo L Carregaro, PhD

  University of Brasilia

  STUDY DIRECTOR

• Fernanda Pasinato, PhD

  University of Brasilia

  STUDY CHAIR

• Thomaz N Burke, PhD

  Federal University of Mato Grosso

  STUDY CHAIR

Central Study Contacts

Maria Augusta A Mota, MS

CONTACT

+55 61 3107-8420; dramariaaugustaaraujo@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blinding the therapists will not be possible due to the nature of the interventions. Because outcomes are self-reported, blinding participants to the intervention will also not be possible. However, an assessor who will be unaware of the group allocation will perform the data collection. The researcher responsible for the statistical analysis will also be blinded to the group allocation (i.e. they will receive the data sheet with the groups/individuals coded numerically).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Model Details: Multicenter trial-based economic evaluation comparing mhealth intervention versus a conventional exercise therapy intervention alone. All participants will be randomly assigned to one of two groups: 1) blended mhealth intervention (mhG) or 2) conventional exercise therapy delivered by a booklet (beG).

Study Record Dates

• First Submitted: October 18, 2024
• First Posted: October 21, 2024
• Study Start: November 15, 2025
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): January 20, 2027
• Last Updated: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (2)