The Value of Evidence and Clinical Research in MSK Digital Therapeutics

How clinical evidence can help providers and employers choose the best digital MSK therapies for their populations

Robust investment in digital health along with the COVID-19 pandemic has supercharged the adoption of digital therapeutics in the U.S., with an increasing number of organizational health and wellness initiatives now focusing on pain management. As a result, employers, health plans, and benefits teams have multiple musculoskeletal (MSK) digital health solutions and platforms to choose from. When looking to narrow down your choices, reviewing clinical research supporting the effectiveness of digital MSK solutions is one of the best places to start.

What is clinical research?

According to the FDA

According to the FDA, a clinical study, trial, or investigation is research that involves human subjects who volunteer to evaluate the safety or effectiveness of a new drug or medical device to help find answers to specific health questions. There are two main types of clinical research: clinical trials and observational studies. Although “trials” and “studies” are often used interchangeably, it’s important to understand the difference between them from a medical standpoint.

Clinical Trial

This is research in which participants are prospectively (in advance) assigned to one or more specific health interventions according to the research plan (protocol) created by the investigators. Clinical trials may compare a new medical approach to a standard one that is already available, to a placebo with no active ingredients, or to no intervention. Clinical trials are usually the most robust and evidence-based method to find out if a new treatment is safe and effective

  • Clinical trials are often used to determine whether a new treatment or intervention is more effective than a placebo (an inactive treatment, such as a sugar pill) or the current standard of care
  • Interventions may include drugs or medical devices, procedures, or behavioral activities such as diet and exercise; and mental health interventions, including digital therapeutics
  • A randomized controlled trial (RCT) usually provides the highest level of evidence possible because it randomly assigns participants into an experimental group (that gets the intervention) and a control group (that gets a placebo or standard of care) and then compares the two

Randomized controlled trial (RCT): A study in which people are allocated at random (by chance alone) to receive one of several clinical interventions. One of these interventions is the standard of comparison or control. The control may be a standard practice, a placebo ("sugar pill"), or no intervention at all. RCTs seek to measure and compare the outcomes after the participants receive the interventions.

MedicineNet

Observational study

This is research that observes people in normal everyday settings to determine how the routine or prescribed treatment or behavior works over time, without influencing or interfering with the treatment or behavior.

  • Researchers collect data through medical exams, tests, or questionnaires about the effects of different lifestyles or physical activity on health. Because these studies are not blinded (i.e., researchers and subjects know they are being studied), there is an increased chance of bias, including selection bias and observation bias, which can affect the study results.
  • Observational studies can investigate the impact of certain behaviors—such as the connection between lifestyles and heart disease—that would be unethical to test in controlled clinical trials, where participants are assigned to treatment and nontreatment groups
  • Observational studies can be prospective or retrospective, with retrospective studies looking back in time to compare different activities or treatments and their outcomes
  • The most common types of observational studies are cohort, cross-sectional, and case-control studies

What makes for a good clinical trial or study?

A “good” clinical trial or study produces evidence-based outcomes that health plans, providers, and businesses can rely upon to evaluate the effectiveness of the intervention. The higher the level of clinical evidence supporting a digital health solution, the more likely the digital health solution is to be effective in your population. Also, the best clinical research is conducted by an institution independent of the company that develops the treatment.

For example, in the Rise-Up trial in Europe, the Kaia Pain app was proven twice as effective as standard-of-care treatment in reducing pain. Furthermore, results demonstrated the app outperformed standard-of-care treatment across all medical outcomes, including in anxiety, depression, stress, functional capability, and well-being. The results of this well-designed RCT—conducted by investigators at an independent institution—were published in the well-respected Journal of Pain Research and helped demonstrate the value of a digital MSK approach to low back pain. Kaia Health is currently recruiting for a similar study, called BACKSPIN, to be conducted in a U.S. population.

The Rise-Up trial was a rigorous, high-quality trial that was well designed and conducted by independent researchers. This is exactly the kind of evidence that employers, payers, and healthcare providers rely upon when looking for a quality musculoskeletal digital therapeutic for their populations.

Justin Yang, M.D., MPH, Kaia Health U.S. Chief Medical Officer

The strongest level of evidence is obtained by conducting in-depth reviews of different RCTs and clinical practice guidelines, an activity known as “systematic review” and “meta analysis.” Conducting a systematic review can take years, sometimes decades, to gather enough results from research studies. Therefore, most studies published about digital health rely on RCTs and observational studies, which are the next most impactful level of evidence that can be gained, as the Hierarchy of Scientific Evidence pyramid demonstrates.

For digital interventions to be trusted and used as therapeutic interventions for MSK pain and other disorders, health plans, providers, and users need to have confidence in the interventions’ effectiveness. In addition to an impressive number of randomized controlled trials and observational studies already published in peer-reviewed journals, Kaia Health has more than 10 active clinical trials or studies in progress.

Questions to ask when choosing a digital MSK solution

  • Are the solution’s claims and methodologies supported by independently published research that has been peer reviewed?
  • Is research active and continuing, so that the latest evidence is always available?
  • What are the shortcomings of current studies, and how are they being addressed?
  • Does the solution put safety first by capturing any reported adverse events associated with clinical trials and with real-world use?

Knowing the answers to these questions can help ensure a high level of confidence in choosing digital MSK solutions that will lead to an improvement in health for employees and a reduction in overall care costs for employers and providers. As the push for value-based care in U.S. healthcare continues, the importance of clinical evidence in digital health will continue to grow and impact health benefit choices in the years to come.

Kaia Health: delivering evidence-based value

The rapid growth of digital therapeutics, combined with the increasing burden of MSK disorders in the U.S. and globally, means it’s more important than ever to seek out digital MSK solutions that deliver evidence-based value and improved health outcomes to your population. By choosing MSK solutions based on solid evidence and rigorous clinical research, organizations have a unique opportunity to improve access to virtual care while boosting health outcomes and saving on medical spend.

Schedule a meeting

To learn more about how we can help your organization evaluate clinical evidence and ensure the safety, success, and well-being of employees, schedule a brief intro call or demo with our team.

Further Reading