First randomized clinical trial provides evidence for drugless treatment
By: Heidi Singer
A University of Toronto researcher has discovered that the right pair of shoes significantly reduces pain associated with knee osteoarthritis.
Prof. Peter Jüni, of the Dalla Lana School of Public Health, tested specially made biomechanical shoes on 220 people who suffered from knee osteoarthritis. He and colleagues from the University of Bern and Boston University found that 80 percent had at least a 50 percent reduction in pain score, measured by the Western Ontario Osteoarthritis Index pain scale.
The researchers published their results online in JAMA May 12.
Jüni, a Swiss-born general internist and epidemiologist, has studied treatments for osteoarthritis for more than 20 years. After a talk he gave at an international conference, the manufacturer of the shoe showed him a video of a patient walking with difficulty before trying the shoes, and then with a smooth gait while wearing them. He was very skeptical. “On the video, it simply looked to good to be true,” he recalls, “but I eventually offered to pilot the shoe on one of the most challenging patients with knee osteoarthritis I knew at the time: my mum.”
Jüni was surprised when he saw his mother walk in the shoes for the first time. “The difference the shoes made was dramatic,” he recalls. “I was actually speechless, and agreed to run a randomized controlled trial.”
Jüni and his colleagues applied for independent funding and ran the trial with a group of osteoarthritis patients wearing the shoes part of each day for six months, and a control group wearing a similar-looking shoe without the biomechanical sole. The company donated the shoes and sent technicians to calibrate them, but was otherwise not involved in the trial.
“The shoe is calibrated to take pressure off the joints and create new ways of retraining the muscles,” says Jüni, a professor in the Faculty of Medicine and at the Dalla Lana’s Institute for Health Policy, Management and Evaluation. In the 20 years that I have been researching arthritis therapies, this is the first time I’ve seen something in addition to conventional physical therapy and weight loss that could actually help and does not lead to major safety concerns, like drugs.”
The shoe must be adjusted periodically, so it wouldn’t be cheap to implement on a mass scale, Jüni notes. But changes are apparent even when people are not wearing the shoe. And it could have similar effects on other arthritis-related pain, such as hip and lower back pain. With about 275 million people worldwide suffering from knee osteoarthritis alone, allowing patients to delay or avoid surgery would be a major health system savings.
“Chronic arthritis pain is very hard to treat, and there have been few breakthroughs,” Jüni notes. “This is the first properly designed trial using this approach, and it’s also the first time I’ve seen anything this exciting.”
The trial was sponsored by Bern University Hospital, coordinated by CTU Bern, the University of Bern’s clinical trials unit and funded by Maxi Foundation and the Canada Research Chairs Programme. The manusfacturer, Apos Medical Assets, provided the biomechanical and control footwear and provided the technicians trained to install and calibrate the external pods on the biomechanical footwear without charge, but was not otherwise involved in the trial.
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