Clinical trial NCT06651099: Trial-based Economic Evaluation of a Mobile Health Intervention for Individuals With Chronic Non-specific Low Back Pain
Official 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)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Low Back Pain
Keywords: Back pain
Mobile health
Economic evaluation
Exercise therapy
Self-management
Lead sponsor: University of Brasilia
Sponsor class: OTHER
Collaborators: name: VU University of Amsterdam
name: Federal University of Mato Grosso
First posted: 2024-10-21
Enrollment: 146
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Disability score as assessed by the Roland-Morris Disability Questionnaire
timeFrame: 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:
measure: Pain intensity as measured using the Numerical Rating Scale (NRS)
timeFrame: 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)
measure: Health-related quality of life (Utility) as measured by the EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) questionnaire
timeFrame: 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)
measure: Fear and beliefs as measured by the Fear Avoidance Beliefs Questionnaire
timeFrame: 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)
measure: Self-efficacy as measured by the Self-Efficacy Questionnaire (PSEQ)
timeFrame: 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)
measure: Perceived recovery as measured by the Global Perceived Effect Scale
timeFrame: 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:
measure: Quality-adjusted life years (QALY)
timeFrame: 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)
measure: Cost-effectiveness
timeFrame: 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)
Locations:
city: Ceilândia
country: Brazil
facility: Universidade de Brasília
state: DF
city: Campo Grande
country: Brazil
facility: Federal University of Mato Grosso do Sul
state: MS
Study officials:
affiliation: University of Brasilia
name: Rodrigo L Carregaro, PhD
role: STUDY_DIRECTOR
affiliation: University of Brasilia
name: Fernanda Pasinato, PhD
role: STUDY_CHAIR
affiliation: Federal University of Mato Grosso
name: Thomaz N Burke, PhD
role: STUDY_CHAIR
References: