Kristiansen T K, Ryaby J P, McCabe J, Frey J J, Roe L R
Community Health Care Plan, New Haven, Connecticut, USA.
J Bone Joint Surg Am. 1997 Jul;79(7):961-73. doi: 10.2106/00004623-199707000-00002.
A multicenter, prospective, randomized, double-blind, placebo-controlled clinical trial was conducted to test the efficacy of a specifically programmed, low-intensity, non-thermal, pulsed ultrasound medical device for shortening the time to radiographic healing of dorsally angulated fractures (negative volar angulation) of the distal aspect of the radius that had been treated with manipulation and a cast. Sixty patients (sixty-one fractures) were enrolled in the study within seven days after the fracture. The patients used either an active ultrasound device (thirty fractures) or a placebo device (thirty-one fractures) daily for twenty minutes at home for ten weeks. The two types of devices were identical except that the placebo devices emitted no ultrasound energy. Clinical examination was performed and radiographs were made at one, two, three, four, five, six, eight, ten, twelve, and sixteen weeks after the fracture by each site investigator. The time to union was significantly shorter for the fractures that were treated with ultrasound than it was for those that were treated with the placebo (mean [and standard error], 61 +/- 3 days compared with 98 +/- 5 days; p < 0.0001). Each radiographic stage of healing also was significantly accelerated in the group that was treated with ultrasound as compared with that 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 as with a significant decrease in the mean time until the loss of reduction 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 of reduction during fracture-healing.
开展了一项多中心、前瞻性、随机、双盲、安慰剂对照临床试验，以测试一种专门编程的低强度、非热、脉冲超声医疗设备，用于缩短经手法复位和石膏固定治疗的桡骨远端背侧成角骨折（掌侧负角）的影像学愈合时间。60例患者（61处骨折）在骨折后7天内纳入研究。患者在家中每天使用有源超声设备（30处骨折）或安慰剂设备（31处骨折）20分钟，持续10周。两种设备除安慰剂设备不发射超声能量外，外观完全相同。每个研究地点的研究人员在骨折后1、2、3、4、5、6、8、10、12和16周进行临床检查并拍摄X线片。超声治疗的骨折愈合时间明显短于安慰剂治疗的骨折（平均[及标准误]，61±3天对比98±5天；p<0.0001）。与安慰剂治疗组相比，超声治疗组的每个影像学愈合阶段也明显加速。与安慰剂治疗相比，超声治疗导致的复位丢失明显更小（掌侧成角程度显示，20±6%对比43±8%；p<0.01），并且复位丢失停止前的平均时间显著缩短（12±4天对比25±4天；p<0.04）。我们得出结论，这种特定的超声信号可加速桡骨远端干骺端骨折的愈合，并减少骨折愈合过程中的复位丢失。
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