DIGITAL THERAPEUTICS FOR CHRONIC PAIN: A RANDOMIZED CONTROL FRAMEWORK

Abstract

Chronic pain is a significant issue in the world, with its prevalence estimated at 20% of all adults and is a major challenge to the community as the condition is persistent, there is no simple etiology, it is costly to treat and affects the lives of most people. The traditional methods of pain management like pharmacological treatments, physical rehabilitation, and cognitive-behavioral treatment are usually constrained by costs, access, adverse effects, and inconsistent compliance by the patients. In the context of the spread of digital health technologies, there has become a promise of digital therapeutics (DTx) in the role of non-pharmacological interventions, which provide evidence-based therapeutic content in the form of software applications. The goals of digital therapeutics to treat chronic pain include self-management support, increase patient engagement, maximize behavioral change, and lower the intensity of pain via personalized digital experiences including mobile applications, web applications, wearables, and virtual assistance. This paper presents an assessment of the usefulness of a randomized controlled model on the use of digital therapeutic interventions to manage chronic pain. The study incorporates both quantitative and qualitative outcomes of the rigorous mixed-method randomized control trial (RCT) design used to combine the quantitative pain outcomes with qualitative outcomes of patient engagement, usability, and quality of life. The participants were 320 individuals with chronic pain in many locations and randomly divided into the digital therapeutic intervention group and the control group, which received conventional care. The main outcomes were measured in the change in pain intensity (validated pain scales), functional disability and psychological distress during 12 weeks. Secondary outcomes were the study of treatment adherence, patient satisfaction, healthcare utilization.