Digital treatment of back pain powered by the Kaia Health app significantly outperforms standard-of-care treatment across all medical outcomes, including pain, anxiety, depression, stress, body function, and well-being.
Clinical validation through high-quality, well-designed clinical trials is critical to the continued adoption and success of digital therapeutics (DTx) in healthcare. This includes the use of randomized controlled trials (RCTs) and other clinical trial design strategies that result in the highest level of control and actionable results, which employers, payers, and healthcare providers rely upon when offering or selecting a DTx for their populations.
In the largest RCT of it’s kind to date, the multidisciplinary Kaia Health Pain Management app proved critical to the success of a digital treatment approach to back pain. This well-controlled, cluster-randomized trial published in the Journal of Pain Research showed that a digital approach to non-specific low back pain (NSBP), which incorporated the Kaia app as a core element, outperformed guideline-based, standard-of-care treatment across all medical outcomes. The study was published as part of the ongoing Rise-uP project, which is investigating the effectiveness of a primary care-focused approach using digital elements to improve the quality of treatment of NSBP.
Results from the trial “Digital Treatment of Back Pain versus Standard of Care: The Cluster-Randomized Controlled Trial, Rise-uP” showed:
Several factors are critical in building quality research, including independence of the investigators, randomization, and the makeup of treatment and control groups. Using the best research design possible helps ensure the most impactful, actionable, and repeatable results, thus supporting even greater acceptance of DTx solutions among employers, payers, and providers. Here’s a look at what separates high-quality research from poor-quality research.
At the end of the three-month follow-up period, a total of 941 patients with NSBP were available for study—with 680 in the Rise-uP intervention group (IG) that included the Kaia Health Pain Management app, and 261 in the control group (CG). Pain rating on the numeric rating scale (NRS; 0 = no pain, 10 = unbearable pain) was the primary outcome measure. Psychological measures (anxiety, depression, stress), functional ability, as well as physical and mental well-being served as secondary outcomes. All values were assessed at the beginning of treatment and at three-month follow-up.
The Rise-uP group showed a significantly stronger pain reduction compared with the control group after three months (IG: 33.3% reduction vs. CG: 14.3% reduction) and was also superior in secondary outcomes.
Investigators noted that high-risk patients—who were motivated to use the Kaia app almost twice as much as lower-risk patients—were able to achieve the same pain level that low-risk patients achieved at the end of three months. Final results of the Rise-uP trial along with an analysis of cost-effectiveness are expected in late 2021.
Advances in technology combined with the COVID-19 pandemic are driving rapid changes in healthcare delivery, including through virtual care and digital solutions. Meanwhile, robust DTx solutions supported by high-quality research are increasing engagement and leading to better health outcomes overall. The multidisciplinary Kaia Health Pain Management app—a driving force in the Rise-uP back pain study—has demonstrated its ability to engage and empower patients with education, physiotherapy, and mindfulness. The power to motivate and improve health also speaks to the Kaia app’s ability to engage key populations and control healthcare benefit costs and claims.
The Kaia Health Pain Management app is a best-in-class digital therapeutic at the forefront of today’s healthcare revolution. While continuing to build a solid foundation of clinical evidence, Kaia Health is expanding its offerings into additional chronic disease areas, including chronic obstructive pulmonary disease (COPD), and hip and knee pain (osteoarthritis).
To learn more about how we can help your organization minimize the impact of chronic musculoskeletal (MSK) pain on physical and mental health, and ensure the safety, success, and well-being of employees, schedule a brief intro call or demo with our team.
