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

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

Author(s): Janosch A Priebe , Katharina K Haas , Leida F Moreno Sanchez , Karin Schoefmann , Daniel A Utpadel-Fischler , Paul Stockert , Reinhard Thoma , Christine Schiessl , Linda Kerkemeyer , Volker Amelung , Siegfried Jedamzik , Jan Reichmann , Ursula Marschall , Thomas R Toelle

Publication date Created: 2020

Publication date (Electronic): July 2020

Journal: Journal of Pain Research

Publisher: Informa UK Limited

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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 guideline-oriented 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.

Most cited references 36

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Non-specific low back pain.

Rachelle Buchbinder, Martin Underwood, Chris Maher (2017)

Non-specific low back pain affects people of all ages and is a leading contributor to disease burden worldwide. Management guidelines endorse triage to identify the rare cases of low back pain that are caused by medically serious pathology, and so require diagnostic work-up or specialist referral, or both. Because non-specific low back pain does not have a known pathoanatomical cause, treatment focuses on reducing pain and its consequences. Management consists of education and reassurance, analgesic medicines, non-pharmacological therapies, and timely review. The clinical course of low back pain is often favourable, thus many patients require little if any formal medical care. Two treatment strategies are currently used, a stepped approach beginning with more simple care that is progressed if the patient does not respond, and the use of simple risk prediction methods to individualise the amount and type of care provided. The overuse of imaging, opioids, and surgery remains a widespread problem.

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The COVID-19 pandemic: The ‘black swan’ for mental health care and a turning point for e-health

Tim Wind, Marleen M. Rijkeboer, Gerhard Andersson … (2020)

In February 2020, Duan and Zhu (2020) stressed the need for a solid Chinese evidence-based mental health care system in times of public health emergencies such as the outbreak of the Coronavirus disease-2019 (COVID-19). That would enable treatment of people who suffer from mental health problems in relation to the epidemic. The WHO has meanwhile labelled the Coronavirus a pandemic, and it is now hitting Europe, the USA, and Australia hard as well. In an attempt to reduce the risk of infections, many mental health care providers in afflicted countries are currently closing their doors for patients who need ambulatory face-to-face therapy. They are simultaneously trying to replace some of these contacts with digital therapies. Most probably, European mental health care institutions have yet to experience the full impact of the coronavirus crisis. At the same time, the demand for mental health care among infected patients and their relatives is expected to rise (Blumenstyk, 2020). Levels of anxiety will increase, both through direct causes including fears of contamination, stress, grief, and depression triggered by exposure to the virus, and through influences from the consequences of the social and economic mayhem that is occurring on individual and societal levels. We expect that this “black swan” moment (Blumenstyk, 2020) - an unforeseen event that changes everything - will lead to a partly, though robust, shift in mental health care provision towards online prevention, treatment, and care in the near future. We also need to consider the role of psychological processes and fear that may cause further harm on top of the pandemic (Asmundson and Taylor, 2020). The obvious solution to continue mental health care within a pandemic is to provide mental health care at a ‘warm’ distance by video-conferencing psychotherapy and internet interventions. A systematic review showed that videoconferencing psychotherapy show promising results for anxiety and mood disorders (Berryhill et al., 2019), and the evidence-base for therapist-guided internet interventions is even stronger (Andersson, 2016). Yet, despite two decades of evidence-based e-mental health services, numerous barriers have stalled the overall implementation in routine care thus far (Vis et al., 2018; Tuerk et al., 2019). One of the most important barriers highlighted, however, has been that e-mental health has not been integrated as a normal part of routine care practice due to the lack of acceptance by health professionals themselves (Topooco et al., 2017). Myths on telehealth such as “the therapeutic alliance can only be established face-to-face” have dominated the field, in spite of research showing the opposite (Berger, 2017). In that sense, learning curves in the adoption of new e-mental health technologies by both patients and psychologists have progressed far more slowly than initially expected, thus tallying with the estimate that it takes on average16 years for a health care innovation to be implemented (Rogers et al., 2017). There are however exceptions in the world but progress is still slow. In the Netherlands and elsewhere, we are now witnessing a phenomenon whereby the outbreak of COVID-19 is hastening managers, ICT-staff, and clinicians to overcome all such barriers overnight, from a pragmatic standpoint seldom seen before. The virus seems a greater catalyst for the implementation of online therapy and e-health tools in routine practice than two decades of many brilliant, but failed, attempts in this domain (Mohr et al., 2018). After all, since predictions about COVID-19 are largely unclear as of yet, it is now time to create a longer-term solution to the problem of heterogeneous patient populations, such as those still active in the community and those that are house-bound or isolated in hospitals. Videoconferencing and internet interventions could therefore be very helpful in mental health care, as well as in physical care and can be easily upscaled to serve isolated regions and reach across borders. Thus, the “black swan virus” has already enabled wide-scale acceptance of videoconferencing by health professionals and patients alike – creating a win-win situation for both. We should stress that e-mental health applications hold value far beyond the provision of videoconferencing psychotherapy in the current situation of crisis. Countries hit by the Corona virus may also consider adopting a wider public e-mental health approach, which would focus additionally on prevention and on reaching people at risk for mental health disorders. In this respect, not only guided but also fully self-guided interventions, such as self-help apps or online therapeutic modules, could also be applied in settings and countries with scarce mental health resources (Christiani and Setiawan, 2018). We should also consider the need for treatment development (for the psychological problems caused by corona virus isolation), which is by far more rapid in the field of internet interventions than in traditional psychotherapy (Andersson et al., 2018). It is likely that the response to this emergency will be more than a temporary increase in online work (Blumenstyk, 2020). Once mental health care institutions have developed the capabilities of serving their patients via videoconferencing and other digital technologies, there is little reason for them to give these up, in view of the many advantages (Blumenstyk, 2020; Tuerk et al., 2019). This black swan should be a call for action by encouraging providers to move more rapidly towards blended care models (van der Vaart et al., 2014; Kooistra et al., 2019). Agility, flexibility, and resilience are essential skills for 21-st-century institutions, particularly when unforeseen disruptive viruses and devastating events driven by climate change are likely to be increasingly common (Blumenstyk, 2020). We urge practitioners to promptly start adopting e-mental health care applications, both as methods to continue their care to current patients in need and as interventions to cope with the imminent upsurge in mental health symptoms due to the coronavirus. Uncited reference Karyotaki et al., 2018

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[Depression, anxiety and stress scales: DASS--A screening procedure not only for pain patients].

P Nilges, C Essau (2015)

The assessment of mental distress is a central aspect in pain research and treatment. Particularly for depression the comorbidity with pain poses methodological and conceptual challenges. This study examined the psychometric properties of the short version of the depression, anxiety and stress scale (DASS), used in both pain research and treatment and constructed to overcome the particular problems by omitting somatic items and concentrating on the psychological core aspects of depression, anxiety and stress.