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NCT Number: NCT06651099

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

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.

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Key information

Conditions

Low Back Pain Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidade de Brasília, Ceilândia, Federal District, Brazil

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. 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)

    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).

Secondary outcomes

  1. 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)

    Pain intensity will be measured using the Numerical Rating Scale (NRS). This scale is characterized by a line with unit scores ranging from 0 to 10, where zero corresponds to no pain and ten corresponds to the worst pain ever experienced. Participants will be instructed to mark a number on the line, representing the pain intensity in the last week

  2. 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)

    The Brazilian-portuguese version of the EQ-5D-5L questionnaire available at Euroqol will be used to assess participants' utility based on five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five response levels (i.e., no problems, slight problems, moderate problems, severe problems, and extreme problems). The scores range from 0 (the value of a health status equivalent to death) to 1 (the value of full health), with higher scores indicating greater health utility.

  3. 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)

    Fear and beliefs will be assessed using the validated Brazilian version of the FAB-Q (Fear Avoidance Beliefs Questionnaire). The FABQ consists of 16 self-report items, divided into two subscales: FABQ-Work, which addresses individuals' fears and beliefs in relation to work, and FABQ-Phys, which addresses their fears and beliefs in relation to physical activities. Each item is assessed on a seven-point Likert scale, ranging from 0 (completely disagree) to 6 (completely agree).

  4. 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)

    Self-efficacy will be assessed using the the Pain Self-Efficacy Questionnaire (PSEQ), translated and validated for Brazilian Portuguese. The PSEQ is a 10-item questionnaire designed to assess the confidence of people with persistent pain in performing various activities, even in the presence of pain. Each item is scored on a 7-point numerical scale (scores from 0 to 6), where 0 means 'not at all confident' and 6 means 'completely confident'. The items assess self-efficacy for a range of functions, including housework, socialising, work, and pain management without medication and with medication. The total score is obtained by summing the scores of the 10 items, resulting in a value between 0 and 60. Higher scores indicate greater perceived self-efficacy.

  5. 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)

    Perceived recovery will be assessed at the end of the intervention period and follow-up moments using the Global Perceived Effect Scale (11-point scale), ranging from -5 ('much worse'), 0 ('no change') to 5 ('completely recovered')

Other outcomes

  1. Quality-adjusted life years (QALY)

    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)

    The QALY will be calculated from the utilities assessed at each of the 5 time points by the EQ-5D-5L questionnaire using the area under the curve method. In this approach, the average utility values between each two time points for each participant are multiplied by the corresponding time periods in weeks. The resulting values are then summed to obtain the total QALYs over the study period (12 months).

  2. Cost-effectiveness

    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)

    Cost outcomes will include healthcare costs (i.e., healthcare utilization costs and intervention costs) and total societal costs (i.e., healthcare utilization costs, intervention costs, informal care costs, and lost productivity costs). Incremental cost-effectiveness ratios (costs per clinical outcome) and cost-utility ratios (costs per QALY gained) will be calculated from the perspectives of the public health system and society.

Study contacts

Contact information is provided by the study sponsor or research team.

Maria Augusta A Mota, MS

CONTACT

[email protected]

+55 61 3107-8420

Sponsors and collaborators

Lead sponsor

University of Brasilia

Other

Collaborators

  • Federal University of Mato Grosso
  • VU University of Amsterdam

Registry information

Official study 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)

Acronym: eBack

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Oct 21, 2024
Registry last updated
Mar 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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