An Educational and Exercise Mobile Phone–Based Intervention to Elicit Electrophysiological Changes and to Improve Psychological Functioning in Adults With Nonspecific Chronic Low Back Pain (BackFit App): Nonrandomized Clinical Trial (Preprint)

BACKGROUND Concomitant psychological and cognitive impairments modulate nociceptive processing and contribute to chronic low back pain (CLBP) maintenance, poorly correlated with radiological findings. Clinical practice guidelines recommend self-management and multidisciplinary educational and exercise-based interventions. However, these recommendations are based on self-reported measurements, which lack evidence of related electrophysiological changes. Furthermore, current mobile health (mHealth) tools for self-management are of low quality and scarce evidence. Thus, it is necessary to increase knowledge on mHealth and electrophysiological changes elicited by current evidence-based interventions. OBJECTIVE The aim of this study is to investigate changes elicited by a self-managed educational and exercise-based 4-week mHealth intervention (BackFit app) in electroencephalographic and electrocardiographic activity, pressure pain thresholds (PPTs), pain, disability, and psychological and cognitive functioning in CLBP versus the same intervention in a face-to-face modality. METHODS A 2-arm parallel nonrandomized clinical trial was conducted at the University of the Balearic Islands (Palma, Spain). A total of 50 patients with nonspecific CLBP were assigned to a self-managed group (23/50, 46%; mean age 45.00, SD 9.13 years; 10/23, 43% men) or a face-to-face group (27/50, 54%; mean age 48.63, SD 7.54 years; 7/27, 26% men). The primary outcomes were electroencephalographic activity (at rest and during a modified version of the Eriksen flanker task) and heart rate variability (at rest), PPTs, and pressure pain intensity ratings. The secondary outcomes were pain, disability, psychological functioning (mood, anxiety, kinesiophobia, pain catastrophizing, and fear-avoidance beliefs), and cognitive performance (percentage of hits and reaction times). RESULTS After the intervention, frequency analysis of electroencephalographic resting-state data showed increased beta-2 (16-23 Hz; 0.0020 vs 0.0024; P=.02) and beta-3 (23-30 Hz; 0.0013 vs 0.0018; P=.03) activity. In addition, source analyses revealed higher power density of beta (16-30 Hz) at the anterior cingulate cortex and alpha (8-12 Hz) at the postcentral gyrus and lower power density of delta (2-4 Hz) at the cuneus and precuneus. Both groups also improved depression (7.74 vs 5.15; P=.01), kinesiophobia (22.91 vs 20.87; P=.002), activity avoidance (14.49 vs 12.86; P<.001), helplessness (6.38 vs 4.74; P=.02), fear-avoidance beliefs (35 vs 29.11; P=.03), and avoidance of physical activity (12.07 vs 9.28; P=.01) scores, but there was an increase in the disability score (6.08 vs 7.5; P=.01). No significant differences between the groups or sessions were found in heart rate variability resting-state data, electroencephalographic data from the Eriksen flanker task, PPTs, subjective ratings, or cognitive performance. CONCLUSIONS Both intervention modalities increased mainly beta activity at rest and improved psychological functioning. Given the limitations of our study, conclusions must be drawn carefully and further research will be needed. Nevertheless, to the best of our knowledge, this is the first study reporting electroencephalographic changes in patients with CLBP after an mHealth intervention. CLINICALTRIAL ClinicalTrials.gov NCT04576611; https://clinicaltrials.gov/ct2/show/NCT04576611