IMPORTANCE: Lower back pain (LBP) is a prevalent and challenging condition in primary care. The effectiveness of an individually tailored self-management support tool delivered via a smartphone app has not been rigorously tested. OBJECTIVE: To investigate the effectiveness of selfBACK, an evidence-based, individually tailored self-management support system delivered through an app as an adjunct to usual care for adults with LBP-related disability. DESIGN, SETTING, AND PARTICIPANTS: This randomized clinical trial with an intention-to-treat data analysis enrolled eligible individuals who sought care for LBP in a primary care or an outpatient spine clinic in Denmark and Norway from March 8 to December 14, 2019. Participants were 18 years or older, had nonspecific LBP, scored 6 points or higher on the Roland-Morris Disability Questionnaire (RMDQ), and had a smartphone and access to email. Interventions: The selfBACK app provided weekly recommendations for physical activity, strength and flexibility exercises, and daily educational messages. Self-management recommendations were tailored to participant characteristics and symptoms. Usual care included advice or treatment offered to participants by their clinician. MAIN OUTCOMES AND MEASURES: Primary outcome was the mean difference in RMDQ scores between the intervention group and control group at 3 months. Secondary outcomes included average and worst LBP intensity levels in the preceding week as measured on the numerical rating scale, ability to cope as assessed with the Pain Self-Efficacy Questionnaire, fear-avoidance belief as assessed by the Fear-Avoidance Beliefs Questionnaire, cognitive and emotional representations of illness as assessed by the Brief Illness Perception Questionnaire, health-related quality of life as assessed by the EuroQol-5 Dimension questionnaire, physical activity level as assessed by the Saltin-Grimby Physical Activity Level Scale, and overall improvement as assessed by the Global Perceived Effect scale. Outcomes were measured at baseline, 6 weeks, 3 months, 6 months, and 9 months. RESULTS: A total of 461 participants were included in the analysis; the population had a mean (SD) age of 47.5 (14.7) years and included 255 women (55%). Of these participants, 232 were randomized to the intervention group and 229 to the control group. By the 3-month follow-up, 399 participants (87%) had completed the trial. The adjusted mean difference in RMDQ score between the 2 groups at 3 months was 0.79 (95% CI 0.06 to 1.51; p = 0.03), favoring the selfBACK intervention. The percentage of participants who reported a score improvement of at least 4 points on the RMDQ was 52% in the intervention group versus 39% in the control group (adjusted odds ratio 1.76; 95% CI 1.15 to 2.70; p = 0.01). CONCLUSIONS AND RELEVANCE: Among adults who sought care for LBP in a primary care or an outpatient spine clinic, those who used the selfBACK system as an adjunct to usual care had reduced pain-related disability at 3 months. The improvement in pain-related disability was small and of uncertain clinical significance. Process evaluation may provide insights into refining the selfBACK app to increase its effectiveness. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT03798288.

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