The role of pain duration and pain intensity on the effectiveness of app-delivered self-management for low back pain: Secondary analysis of the SELFBACK randomized controlled trial (Preprint)

Abstract

BACKGROUND mHealth solutions are a promising method for delivering tailored self-management interventions to patients with non-specific low back pain (LBP). However, it is not clear if the effectiveness of such self-management interventions depends on patients’ initial pain characteristics. High pain intensity and long-term symptoms of LBP have been associated with an unfavorable prognosis, and current best evidence indicates that long-term LBP (lasting more than 3 months) requires a more extensive treatment approach compared to acute LBP. The artificial intelligence-based SELFBACK app supports tailored and evidence-based self-management of non-specific LBP and have been shown to reduce LBP-related disability. OBJECTIVE To explore if baseline duration and intensity of LBP modify the effectiveness of the SELFBACK intervention. METHODS In this secondary analysis of the SELFBACK randomized controlled trial (RCT), we explore if baseline duration and intensity of LBP modify the effectiveness of the SELFBACK intervention. In the RCT, 461 adults who sought care for LBP in primary care or an outpatient spine clinic were randomized to receive the SELFBACK intervention adjunct to usual care (n=232) or usual care alone (n=229). Participants were then stratified according to duration of the current LBP episode at baseline (≤12 weeks vs >12 weeks) or baseline LBP intensity (≤5 points vs >5 points) measured by a 0-10 numeric rating scale (NRS). Outcomes were LBP-related disability measured by the Roland Morris Disability Questionnaire, average LBP intensity (NRS), pain self-efficacy, and global perceived effect. RESULTS Overall, there was no clear effect modification by duration or intensity of LBP at either three or nine months follow-up. However, there was suggestive evidence that the effect of the SELFBACK intervention on LBP-related disability at three months was largely confined to people with the highest vs the lowest LBP intensity (mean difference between the intervention and control group; -1.8 [95% CI -3.0 to -0.7] vs 0.2 [95% CI -1.1 to 0.7], respectively), but that this was not sustained at 9 months. CONCLUSIONS The results suggest that intensity and duration of LBP have negligible influence on the effectiveness of the SELFBACK intervention on LBP-related disability, average LBP intensity, pain self-efficacy and global perceived effect. CLINICALTRIAL The multicenter SELFBACK RCT is registered in Clinicaltrials.gov: (NTC03798288). Registered 7 January 2019. INTERNATIONAL REGISTERED REPORT RR2-10.2196/14720

Do age, gender, and education modify the effectiveness of app-delivered and tailored self-management support among adults with low back pain?—Secondary analysis of the selfBACK randomised controlled trial

“…Monitoring of usual care was not a part of the RCT protocol, and a possible synergistic effect between self-management support and type of usual care for the different age groups cannot be excluded. However, another secondary analysis from the SELFBACK RCT did not find that the effect of the SELFBACK intervention was modified by the duration of the current LBP episode at baseline, nor by LBP intensity at baseline [31].…”

“…Participants reported their age (number of years), gender (male, female) and their educational background (less than 10 years of schooling, 10 to 12 years of schooling, or more than 12 years of schooling). To assess a potential effect modification, the population were stratified based on their baseline age (18)(19)(20)(21)(22)(23)(24)(25)(26)(27)(28)(29)(30)(31)(32)(33)(34)35-64, �65 years), gender (male, female) and education length (�12, >12 years), respectively.…”

“…The SELFBACK RCT included participants across a wide age-range (18-86 years), complementing previous studies, which mainly included middle-aged adults [14]. This heterogeneity has enabled several secondary analyses investigating effect modification across LBP characteristics, such as multimorbidity and co-occurring musculoskeletal pain [13] and pain intensity and duration at baseline [31]. Further, secondary analyses may identify subgroups more likely to benefit from the intervention than other subgroups; however, we have so far not found any consistent effect modification related to the SELFBACK intervention, which may be due to the individual tailoring of the intervention [10].…”