Effectiveness of app-delivered, tailored self-management support for adults with lower back pain-related disability: a selfBACK randomized clinical trial.

Sandal, Louise Fleng; Bach, Kerstin; �ver�s, Cecilie K.; Wiratunga, Nirmalie; Cooper, Kay

Abstract

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, 0.06-1.51; P=.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 vs 39% in the control group (adjusted odds ratio, 1.76; 95% CI, 1.15-2.70; P=.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.

Citation

SANDAL, L.F., BACH, K., ØVERÅS, C.K., WIRATUNGA, N., COOPER, K, et al. 2021. Effectiveness of app-delivered, tailored self-management support for adults with lower back pain-related disability: a selfBACK randomized clinical trial. JAMA internal medicine [online], 181(10), pages 1288-1296. Available from: https://doi.org/10.1001/jamainternmed.2021.4097

• Journal Article Type: Article
• Acceptance Date: Jun 11, 2021
• Online Publication Date: Aug 2, 2021
• Publication Date: Oct 31, 2021
• Deposit Date: Aug 5, 2021
• Publicly Available Date: Aug 5, 2021
• Journal: JAMA internal medicine
• Print ISSN: 2168-6106
• Electronic ISSN: 2168-6114
• Publisher: American Medical Association (AMA)
• Peer Reviewed: Peer Reviewed
• Volume: 181
• Issue: 10
• Pages: 1288-1296
• DOI: https://doi.org/10.1001/jamainternmed.2021.4097
• Keywords: SelfBACK; Evidence-based; Self-management support system; Lower back pain (LBP); Smartphone app
• Public URL: https://rgu-repository.worktribe.com/output/1400226
• Related Public URLs: https://rgu-repository.worktribe.com/output/1400289