BACKGROUND: The recommended first-line treatment for non-specific and degenerative back pain consists of movement exercises and patient education. OBJECTIVE: Using a pragmatic, randomized controlled trial, we evaluated the effectiveness of a digital home exercise program on self-reported pain intensity, compared to the standard of care of physiotherapy. METHODS: Participant recruitment was based on newspaper advertisements and a consecutive on-site assessment for eligibility and enrollment. Participants with unspecific and degenerative back pain aged >= 18 years were randomly assigned in a 1:1 ratio to receive a 12-week stand-alone digital home exercise program or physiotherapy. The digital home exercise program included four exercises daily, while physiotherapy included six to twelve sessions, depending on severity of symptoms. The primary outcome was pain, which was assessed using a verbal numerical rating scale (VNRS). Clinical relevance of pain reduction was assessed using the following thresholds: improvement of at least 1.4 points on the VNRS and a pain reduction of at least 30%. RESULTS: During the study period, 108 participants were assigned to the intervention and 105 to the control group. The mean difference in pain score between the 2 groups at 12 weeks was -2.44 (95% CI -2.92 to -1.95, p < 0.01), in favor of the intervention group. The group receiving the digital therapeutic achieved a clinically relevant reduction in pain over the course of the study (baseline versus 12 weeks), with a mean change of -3.35 (SD 2.05) score points or -53.1% (SD 29.5). In contrast, this change did not reach clinical relevance in the control group (mean -0.91, SD 1.5; -14.6%, SD 25.3). Retention rates of 89.9% in the intervention group and 97.3% in the control group were maintained throughout the study. CONCLUSIONS: The use of the app-based home exercise program assessed leads to a significant and clinically relevant reduction in pain intensity throughout the 12-week duration of the program. The intervention studied shows superior improvement in self-reported pain intensity when compared to the standard of care. Given the great demand for standard physiotherapy for unspecific and degenerative back pain, digital therapeutics are evolving to a suitable therapeutic option that can overcome limitations of access and availability of conventional modes of health care delivery int this spectrum of indications. Yet, further independent evaluations are required to support the growing body of evidence on the effectivenes of digital therapeutics in real-world care settings. CLINICALTRIAL: German Clinical Trials Register DRKS00022781; https://www.drks.de/.

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