The use of ultrasound to promote healing after surgical repair of a bone fracture is a popular treatment, but it doesn’t work, a new study finds.
Broken bones result from many causes, including accidents, sports injuries, and medical conditions such as osteoporosis, which can cause bones to become brittle and fracture more easily.
But in a clinical trial, published in BMJ, a team of Canadian researchers found no difference in the recovery time between using low intensity pulsed ultrasound (LIPUS) or a placebo device for patients with a fractured tibia (shinbone).
The international research team conducted a randomized controlled trial of 501 patients at 43 academic trauma centers in North America who underwent the surgical repair for the lower leg fracture between 2008 and 2012.
The patients were assigned 20-minute daily treatment with either a LIPUS or a placebo device that looked the same.. Patients were followed until x-rays showed their fracture was healed, or for 12 months.
The researchers found no difference in time to functional recovery whether patients were treated with the active or placebo device. There was also no difference in quality of life, return to work, leisure activities, or time to full weight bearing.
LIPUS, which generates about $250 million in sales a year, was approved in 1994 by the U.S. Food and Drug Administration on the basis of small trials and radiographic outcomes, and not studies looking on patient outcomes, the researchers say.
Xavier Griffin, an associate professor of trauma surgery in the U.K., noted, in an accompanying editorial, that the results were clear.
“These authors report important patient-centered outcomes…showing that low intensity pulsed ultrasound is of no benefit to adults with tibia fractures,” he said, adding, “It is time for us to make good use of their determination and abandon this ineffective treatment.”