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.
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;
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;
Parallel
mhealth application
Other interventionIndividuals 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 interventionParticipants 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.
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).
Pain intensity as measured using the Numerical Rating Scale (NRS)
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
Health-related quality of life (Utility) as measured by the EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) questionnaire
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.
Fear and beliefs as measured by the Fear Avoidance Beliefs Questionnaire
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).
Self-efficacy as measured by the Self-Efficacy Questionnaire (PSEQ)
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.
Quality-adjusted life years (QALY)
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).
Cost-effectiveness
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.
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University of Brasilia
Lead sponsor
VU University of Amsterdam
Collaborator
Federal University of Mato Grosso
Collaborator
