In patients with tibia (shinbone) fractures, receiving ultrasound after undergoing repair surgery does not speed healing or improve functional recovery, suggests a study published recently in The BMJ.
An editorial regarding the study goes even further, suggesting that there is now sound evidence that postsurgical ultrasound doesn’t work and that “it is time to abandon this ineffective treatment,” according to a media release from BMJ.
The treatment, called low intensity pulsed ultrasonography (LIPUS), was approved by the FDA to treat fractures in 1994, and is now widely used across the United States. However, results from previous trials investigating its effectiveness have been inconclusive.
In this most recent study, researchers from the United States and Canada conducted a randomized controlled trial in which 501 US adults received either LIPUS or a sham treatment after undergoing surgery for a tibial fracture at 43 North American academic trauma centers between October 2008 and September 2012.
The participants’ primary outcome was time to fracture healing over 1 year, assessed via radiographs (radiographic healing). Other outcomes included return to work and leisure activities, and return to full weight bearing, per the release.
During their recovery period, each study participant received a device to use once per day for 20 minutes at home until their surgeon determined that their fracture showed radiographic healing—or until the 52-week follow-up visit, whichever occurred first.
Active and sham devices had the same visual, tactile, and auditory signals and were therefore indistinguishable.
The researchers found no significant differences between either the LIPUS or sham treatment groups for any outcome, the release continues.
“Addition of LIPUS to usual care for patients with fracture failed to accelerate radiographic healing or improve function,” the researchers conclude in the release.
Xavier Griffin, associate professor of Trauma Surgery at the University of Oxford, notes in an editorial regarding this study that there is now sound evidence that the LIPUS treatment does not work.
“Fortunately for patients, clinicians, and future clinical guideline groups, the results were eventually clear, despite the influence of outside agencies,” he says.
“These authors report important patient-centered outcomes with a precise estimate, showing that low intensity pulsed ultrasound is of no benefit to adults with tibial fractures treated with an intramedullary nail,” Griffin continues. “It is time for us to make good use of their determination and abandon this ineffective treatment.”
[Source(s): BMJ, Science Daily]