San Francisco-based Hinge Health has completed a randomized control trial of its digital care program for chronic knee pain. Results were promising, with users of the digital platform outperforming the control group in every outcome measure, though there was some loss of engagement among the study group.

“It was really strong results,” CEO Daniel Perez told MobiHealthNews. “It was a trial that was pre-registered and approved, and we also saw significant reduction in [self-reported intent to have] surgery for the treatment group and almost a negligible reduction in surgery for the control group.”

The study, published last month in the Journal of Medical Internet Research, looked at a group of 162 employees with knee pain symptoms who were considering surgery. One hundred and one were given Hinge Health’s platform, which includes a tablet app, digitally-delivered education, personalized coaching based on CBT, and Bluetooth-connected wearable sensors. The control group received just the education module, and both groups received regular care.

Participants’ knee pain was assessed at the beginning of the trial period and at 12 weeks using two different scales: the Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain subscale, a validated measure, and visual analog scales for pain and stiffness. Participants were also asked how likely they were to have surgery on a scale of one to 10.

Those in the digital treatment group reduced their pain on the KOOS 100-point scale by an average of 7.7 points more than the control group (a 12-point reduction versus a three-point one). On the visual analog scales, for pain and stiffness, the digital group dropped 19.1 and 21.1 points, respectively, compared to drops of just 5.4 and 5.6 for the control group.

Digital group participants were also much less likely to say they were interested in surgery at the end of the program and more likely to display an understanding of their condition and treatment options.

Randomized control trials are still not common in the realm of digital health. But Hinge Health chose to pursue one for a number of reasons, including to lay the groundwork for a future FDA submission.

“[My cofounder and I] come from an academic background and it just kind of comes naturally to us that this is how you demonstrate efficacy, to both the market, but also to other clinicians that you actually work. So it was a natural decision for us, to go for a more rigorous study,” Perez said. “We’ve continually learned and improved our behavioral health techniques and our behavioral health interventions. I want to be clear, when it comes to Hinge Health, our secret sauce is in our behavioral health interventions. Even our sensor technology is most useful because it’s paired with our coaching and our behavioral health interventions that we deliver. And that’s simply getting better and better as we go.”

The next step for the company, datawise, will be to prove that the 12-week results demonstrated here can translate into long-term improvements and ROI.