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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

146 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-01

Study Completion Date

2027-01-20

Brief Summary

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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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Detailed Description

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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.

Conditions

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Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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).

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

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).

Study Groups

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mhealth application (experimental group)

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.

Group Type EXPERIMENTAL

mhealth application

Intervention Type 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 booklet exercise (comparator group)

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.

Group Type ACTIVE_COMPARATOR

Conventional exercise therapy

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Adults aged between 18 and 59 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 and/or pain radiating below the knee;
* Pregnancy.

Minimum Eligible Age

18 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No