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Kaia Health’s App-Based Back Pain Treatment Outperforms Standard Physiotherapy in Clinical Trial

New York, May 7, 2019 – Kaia Health, a digital therapeutics company, announced results from the first randomised controlled trial of its app-based therapy program for patients with non-specific low back pain. Detailed results of the study were published in the journal NPJ Digital Medicine and showed that patients using Kaia, a downloadable app for back pain, reported significantly lower pain levels compared to the control group treated with physiotherapy and online education.

“This study can help add to the growing body of evidence that generally supports the use of multimodal treatments for chronic conditions,” said Thomas R. Tölle, M.D., Ph.D., Head of Pain Medicine, Technical University Munich, Germany. “Within this study, we saw a notable benefit for people managing low back pain when delivering multimodal treatment through the digital modality of the smartphone, as is done in the Kaia app.”

Low back pain is one of the leading causes of global disability, and treatment is expensive.1,2 According to the Office for National Statistics, back, neck and muscle problems account for almost 31 million days of work lost in 2013 costing the UK economy £14 billion per year – with an estimated one-third of the UK adult population affected by back pain annually.3,4

“As a company, we want to support the improvement of the current standard of care for people living with back pain,” said Konstantin Mehl, Founder and CEO, Kaia Health. “And while these study results are promising, we will be initiating a similar U.S.-based study looking at the use of the Kaia app for self-management of back pain.” 

About the Randomised Controlled Trial5

In the study, analysed patients with low back pain were treated using two methods. The first group used Kaia Health’s multi-platform mHealth app (n=42), while a second control group was treated using a standard therapy program consisting of 6 once-weekly, in-person physiotherapy sessions guided by a certified therapist plus sophisticated online education about back pain delivered to patients weekly with a motivating email (n=44). Both groups were encouraged to live an active lifestyle and perform the therapeutic exercises at home, but the app provided three therapy modules – back pain education; physiotherapy; and mindfulness and relaxation techniques – and recommended a 3 to 4 times-per-week exercise plan that could be personalised for each user. App users also could interact with a human coach via the app if they had questions.

Both the control and Kaia app treatment groups experienced significant pain reduction over the course of 12 weeks. However, after 3 months, patients using the Kaia app reported substantially larger decrease in their back pain intensity than control group patients: 2.4 vs. 2.0, respectively, on a numeric rating scale ranging from 0 to 10 (where higher numbers represent more pain). The decrease suggests that Kaia may be an effective treatment for low back pain over a 3-month timeframe.

About Kaia App

Kaia is a smartphone-based approach for managing chronic back pain.

In Europe, Kaia is regulated as a Class I medical device. Currently, Kaia is working with the U.S. Food and Drug Administration (FDA) to seek regulatory clearance in the U.S.

About Kaia Health

Kaia Health is a digital therapeutics company that creates accessible, evidence-based treatments for a range of disorders including back pain and COPD. Working with experts in various medical fields, the company uses technology such as machine learning algorithms, to deliver individualised app interventions that aim to empower and motivate patients to take control and self-manage their condition with digital alternatives from their home using devices they already own (i.e., smartphones and tablets). Kaia Health is member of the Digital Therapeutics Alliance (DTA), an international association of manufacturers that set industry standards for what clinical evidence levels are required to call a product a digital therapeutic. Kaia Health is located in New York City. For more information about Kaia Health, visit www.kaiahealth.com.

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References:

  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 (Lond., Engl.) 390, 1260–1344 (2017).
  2. Maher, C., Underwood, M. & Buchbinder, R. Non-specific low back pain. Lancet (Lond., Engl.) 389, 736–747 (2017).
  3. NHS Employers. Bad backs cost the UK 31 million days of work costing the UK economy £14bn a year
  4. British Pain Society. Chronic pain costs the UK £billions but research funding is inadequate (2018)
  5. Toelle, Thomas R. et al. App-based multidisciplinary back pain treatment versus combined physiotherapy plus online education: A randomized controlled trial. npj Digital Medicine, volume 2, Article number: 34 (2019)