A study
published in the BMJ
suggests that low-intensity pulsed ultrasound, used to speed healing of bone
fractures, may be ineffective.
A randomized clinical trial that
involved 501 patients who had surgical repair of fractures of the tibia found
that patients treated with the low-intensity pulsed ultrasound (LIPUS) healed
at the same rate as those given a sham treatment.
Patients self administer
daily LIPUS (n=250) or use a sham device (n=251) until their tibial fracture
showed radiographic healing or until one year after intramedullary fixation.
Primary registry
specified outcome was time to radiographic healing within one year of fixation;
secondary outcome was rate of non-union. Additional protocol specified outcomes
included short form-36 (SF-36) physical component summary (PCS) scores, return
to work, return to household activities, return to ≥80% of function before
injury, return to leisure activities, time to full weight bearing, scores on
the health utilities index (mark 3), and adverse events related to the device.
Results showed no
impact on SF-36 PCS scores between LIPUS and control groups or for the
interaction between time and treatment; minimal important difference is 3-5
points or in other functional measures. There was also no difference in time to
radiographic healing. There were no differences in safety outcomes between
treatment groups. Patient compliance was moderate; 73% of patients administered
≥50% of all recommended treatments.
It
was concluded that postoperative
use of LIPUS after tibial fracture fixation does not accelerate radiographic
healing and fails to improve functional recovery.
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