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

University of Brasilia

Status: Not yet enrolling

Conditions: Low Back Pain

Treatments: Other: mhealth application; Other: Conventional exercise therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06651099

6.674.643

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 146 estimated patients

Sex: All

Ages: 18 to 59 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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146 participants in 2 patient groups

mhealth application (experimental group)

Experimental group

Description:

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.

Treatment:

Other: mhealth application

Conventional booklet exercise (comparator group)

Active Comparator group

Description:

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.

Treatment:

Other: Conventional exercise therapy