ACCELERATED HEALING OF DISTAL RADIAL FRACTURES WITH THE USE OF SPECIFIC, LOW-INTENSITY ULTRASOUND - A MULTICENTER, PROSPECTIVE, RANDOMIZED,DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY

A multicenter, prospective, randomized, double-blind, placebo-controll ed clinical trial was conducted to test the efficacy of a specifically programmed, low-intensity, non-thermal, pulsed ultrasound medical dev ice for shortening the time to radiographic healing of dorsally angula ted fractures (negative volar angulation) of the distal aspect of the radius that had been treated with manipulation and a cast, Sixty patie nts (sixty-one fractures) were enrolled in the study within seven days after the fracture, The patients used either an active ultrasound dev ice (thirty fractures) or a placebo device (thirty-one fractures) dail y for twenty minutes at home for ten weeks, The two types of devices w ere identical except that the placebo devices emitted no ultrasound en ergy, Clinical examination was performed and radiographs were made at one, two, three, four, five, six, eight, ten, twelve, and sixteen week s after the fracture by each site investigator, The time to union was significantly shorter for the fractures that were treated with ultraso und than it was for those that were treated with the placebo (mean [an d standard error], 61 +/- 3 days compared with 98 +/- 5 days; p < 0.00 01), Each radiographic stage of healing also was significantly acceler ated in the group that was treated with ultrasound as compared with th at treated with the placebo, Compared with treatment with the placebo, treatment with ultrasound was associated with a significantly smaller loss of reduction (20 +/- 6 per cent compared with 43 +/- 8 per cent; p < 0.01), as determined by the degree of volar angulation, as well a s with a significant decrease in the mean time until the loss of reduc tion ceased (12 +/- 4 days compared with 25 +/- 4 days; p < 0.04). We concluded that this specific ultrasound signal accelerates the healing of fractures of the distal radial metaphysis and decreases the loss o f reduction during fracture-healing.