Medical Device News Magazine reports in the largest independent randomized controlled trial (RCT) of its type, a multimodal app-based therapy program for patients with non-specific low back pain has outperformed standard-of-care treatment across all medical outcomes. Results of the study, published in the Journal of Pain Research, show that patients using Kaia, the back pain management app developed by leading digital therapeutics company Kaia Health, reduced pain levels, anxiety, depression, stress, and improved wellbeing and body functionality significantly more compared to standard-of-care treatments (which can be whatever the physicians typically prescribe, e.g. pain killers, surgeries, physical therapy).
“This large-scale study demonstrates the significant benefits for people managing low back pain when using Kaia to deliver a multimodal treatment through a digital device, such as a smartphone,” says Thomas R. Toelle, M.D., Ph.D., Head of the Pain Center of the Technical University Munich, Germany. “These results add to the growing body of medical evidence that supports the use of digital multimodal treatments for chronic conditions, such as back pain.”
Low back pain is one of the leading causes of global disability, with an enormous cost for healthcare systems worldwide. 1,2 According to a 2018 report on the impact of musculoskeletal pain on employers, chronic pain, including back pain, accounts for 188.7 million lost work days, and $62.4 billion in lost productivity cost.3
“COVID is changing the way that health care is delivered and driving a meaningful increase in demand for multimodal virtual therapy solutions. We’re focused on the highest level of clinical rigor to protect the health of patients, and significantly improve their chronic pain; remotely, effectively and at scale,” says Kaia Founder and President, Konstantin Mehl. “Companies looking to integrate digital back pain therapy into their health plan for employees can trust that the Kaia treatment is medically sound.”
Kaia Health recently announced news of a $26 million Series B funding, which included new investment from top healthcare VC Optum Ventures and world number one ranked Golfer Rory McIlroy.
About the Cluster-Randomised Controlled Trial: In the study, 1,245 patients with low back pain were randomized either to the intervention group (n=933) or the control group (n=312). The intervention group (IG) used the Kaia app with physicians applying a treatment algorithm. In the control group (CG), physicians prescribed standard-of-care treatments. 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.
Patients were assessed at the beginning of the treatment and at 3-month follow-ups. The IG group showed a significantly stronger pain reduction compared to the CG after three months (IG: M=-33.3% vs CG: M=-14.3%). The IG 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%).
1. Dalys, G. B. D. & Collaborators, H. Global, regional, and national disability-adjusted life-years (DALYs) for 333 diseases and injuries and healthy life expectancy (HALE) for 195 countries and territories, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet 390, 1260–1344 (2017).
2. Maher, C., Underwood, M. & Buchbinder, R. Non-specific low back pain. Lancet 389, 736–747 (2017).
4. Priebe, Janosch A. et al. Digital treatment of back pain versus standard of care: The cluster-randomized controlled trial, Rise-uP (2020) https://www.dovepress.com/digital-treatment-of-back-pain-versus-standard-of-care-the-cluster-ran-peer-reviewed-fulltext-article-JPR#