Digital Therapeutics (DTx) Expand Multimodal Treatment Options for Chronic Low Back Pain: The Nexus of Precision Medicine, Patient Education, and Public Health

Abstract

Digital therapeutics (DTx, software as a medical device) provide personalized treatments for chronic diseases and expand precision medicine beyond pharmacogenomics-based pharmacotherapies. In this perspective article, we describe how DTx for chronic low back pain (CLBP) can be integrated with pharmaceutical drugs (e.g., NSAIDs, opioids), physical therapy (PT), cognitive behavioral therapy (CBT), and patient empowerment. An example of an FDA-authorized DTx for CLBP is RelieVRx, a prescription virtual reality (VR) app that reduces pain severity as an adjunct treatment for moderate to severe low back pain. RelieVRx is an immersive VR system that delivers at-home pain management modalities, including relaxation, self-awareness, pain distraction, guided breathing, and patient education. The mechanism of action of DTx is aligned with recommendations from the American College of Physicians to use non-pharmacological modalities as the first-line therapy for CLBP. Herein, we discuss how DTx can provide multimodal therapy options integrating conventional treatments with exposome-responsive, just-in-time adaptive interventions (JITAI). Given the flexibility of software-based therapies to accommodate diverse digital content, we also suggest that music-induced analgesia can increase the clinical effectiveness of digital interventions for chronic pain. DTx offers opportunities to simultaneously address the chronic pain crisis and opioid epidemic while supporting patients and healthcare providers to improve therapy outcomes.

Implementation of eLearning solutions for patients with chronic pain conditions

“…Beyond mHealth eLearning solutions, patients with chronic pain may be further helped through advanced behavior change interventions supported by mHealth and via digital therapeutics such as augmented and virtual reality-based psychology and mindfulness training. 31 , 32 Despite growing evidence of the helpfulness of mHealth solutions for clinical care, and the growing interests on behalf of both patients and providers, little guidance exists into how to best incorporate this new class of tools into routine clinical care.…”

Digital Therapeutics for Improving Effectiveness of Pharmaceutical Drugs and Biological Products: Preclinical and Clinical Studies Supporting Development of Drug + Digital Combination Therapies for Chronic Diseases

“…Given the analgesic properties of music [149,150,[178][179][180][181][182], this non-pharmacological modality is underutilized as an adjunct digital intervention [183,184]. The compatibility of DTx with other pharmacological and non-pharmacological treatments as drug + digital combination therapies for chronic pain was highlighted in Figures 6 and 7 in the perspective article [24].…”

“…For preclinical studies, our group described an approach to evaluate DTx "active ingredients" (audiogenic stimulation, cognitive stimulation, physical activities) in combination with pharmaceutical drugs [23], and proposed a preclinical strategy to evaluate drug + digital combination therapies in animal models of human diseases, using environ-mental enrichment (EE) as a surrogate for digital interventions (Table 3 in [23]). While research studies show clinical and cost-effectiveness benefits of digital interventions for diverse chronic conditions, to the best of our knowledge, there are no published studies on integrating pharmacological and digital interventions via drug + digital combination products [14,19,24,25].…”

Redesigning Pharmacy to Improve Public Health Outcomes: Expanding Retail Spaces for Digital Therapeutics to Replace Consumer Products That Increase Mortality and Morbidity Risks

“…[ 27 , 31 , 32 , 33 , 34 , 35 , 36 ]. As illustrated in Table 1 , RelieVRx is an example of an FDA-authorized PDT that uses a VR system to reduce the severity of chronic low back pain (CLBP) [ 37 , 38 , 39 ]. Examples of OTC DTx and PDT are EndeavorOTC and EndeavorRx, video game apps that can improve focus and cognitive functions in adults and pediatric patients with ADHD, respectively [ 40 , 41 , 42 ].…”