<p>Digital Treatment of Back Pain versus Standard of Care: The Cluster-Randomized Controlled Trial, Rise-uP</p>

Abstract

Purpose: Non-specific low back pain (NLBP) causes an enormous burden to patients and tremendous costs for health care systems worldwide. Frequently, treatments are not oriented to existing guidelines. In the future, digital elements may be promising tools to support guidelineoriented treatment in a broader range of patients. The cluster-randomized controlled "Rise-uP" trial aims to support a General Practitioner (GP)-centered back pain treatment (Registration No: DRKS00015048) and includes the following digital elements: 1) electronic case report form (eCRF), 2) a treatment algorithm for guideline-based clinical decision making of GPs, 3) teleconsultation between GPs and pain specialists for patients at risk for development of chronic back pain, and 4) a multidisciplinary mobile back pain app for all patients (Kaia App). Methods: In the Rise-uP trial, 111 GPs throughout Bavaria (southern Germany) were randomized either to the Rise-uP intervention group (IG) or the control group (CG). Rise-uP patients were treated according to the guideline-oriented Rise-uP treatment algorithm. Standard of care was applied to the CG patients with consideration given to the "National guideline for the treatment of non-specific back pain". Pain rating on the numeric rating scale was the primary outcome measure. Psychological measures (anxiety, depression, stress), functional ability, as well as physical and mental wellbeing, served as secondary outcomes. All values were assessed at the beginning of the treatment and at 3-month follow-ups. Results: In total, 1245 patients (IG: 933; CG: 312) with NLBP were included in the study. The Rise-uP group showed a significantly stronger pain reduction compared to the control group after 3 months (IG: M=−33.3% vs CG: M=−14.3%). The Rise-uP group was also superior in secondary outcomes. Furthermore, high-risk patients who received a teleconsultation showed a larger decrease in pain intensity (−43.5%) than CG patients (−14.3%). ANCOVA analysis showed that the impact of teleconsultation was mediated by an increased training activity in the Kaia App. Conclusion: Our results show the superiority of the innovative digital treatment algorithm realized in Rise-uP, even though the CG also received relevant active treatment by their GPs. This provides clear evidence that digital treatment may be a promising tool to improve the quality of treatment of non-specific back pain. In 2021, analyses of routine data from statutory health insurances will enable us to investigate the cost-effectiveness of digital treatment.

Prevalence and predictors of no-shows to physical therapy for musculoskeletal conditions

“…The risk prediction model we developed and validated has the potential to lead to the development of interventions that increase the efficiency of care and capacity to deliver non-pharmacologic treatments for MSK conditions. For example, patients identified as likely to no-show could be offered tele-health to replace or augment care delivered in a traditional clinic setting [35][36][37][38].…”

Digital Therapeutic Care and Decision Support Interventions for People With Low Back Pain: Systematic Review

“…Of the 12 studies, 6 (50%) [28][29][30][31][32][33] were RCTs and 4 (33%) [34][35][36][37] had a retrospective cohort design, whereas the remaining 2 (17%) were a retrospective evaluation [38] and a prospective single-arm trial [39], respectively. Of the 12 studies, 5 (42%) were published in 2020 [28,33,34,37,39], 3 (25%) in 2019 [29][30][31], 3 (25%) in 2018 [32,36,38], and 1 (8%) in 2017 [35]; moreover, 2 (17%) each were conducted in the United States [30,34], Germany [28,31], and China [29,38], 1 (8%) in India [32], and 1 (8%) in Jordan [33], whereas the remaining 3 (25%) were conducted in multiple countries. Of these 3 studies, 1 was conducted in Denmark and Norway [39] and 1 included participants from Germany, Austria, and Switzerland [35].…”

“…The study durations with regard to the digital therapeutic intervention did not vary significantly. In 58% (7/12) [28,[30][31][32]34,35,37] of the studies, the intervention was investigated for 12 weeks or 3 months, 17% (2/12) [33,39] had an intervention duration of 6 weeks, 17% (2/12) had an intervention duration of 24 weeks [36] and 24 months [29], whereas in 8% (1/12) [38], the duration was inconsistent and not clearly reported.…”

User Engagement and Clinical Impact of the Manage My Pain App in Patients With Chronic Pain: A Real-World, Multi-site Trial

“…None have been scientifically validated for their impact on pain-related clinical outcomes [ 16 , 17 ]. The few digital pain management solutions that have been scientifically validated for positive clinical impact are specific to patients with lower back pain rather than focused on generalized chronic pain, which is prevalent in a multitude of patients with underlying medical conditions [ 22 ]. Furthermore, most studies do not address the effectiveness of mobile pain apps based on clinical setting, despite major lifestyle differences of individuals who live in urban and rural areas [ 23 ].…”