Accelerated healing of distal radial fractures with the use of specific, low-intensity ultrasound - A multicenter, prospective, randomized, double-blind, placebo-controlled study
Accelerated healing of distal radial fractures with the use of specific, low-intensity ultrasound - A multicenter, prospective, randomized, double-blind, placebo-controlled study
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DOI：
10.2106/00004623-199707000-00002
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发表时间：
1997-07-01
影响因子：
5.3
通讯作者：
Roe, LR
中科院分区：
文献类型：
--
作者：
Kristiansen, TK;Ryaby, JP;Roe, LR
进行了一项多中心、前瞻性、随机、双盲、安慰剂对照的临床试验，以测试一种专门编程的、低强度、非热脉冲超声医疗器械缩短背侧成角骨折影像学愈合时间的有效性（负掌侧成角）的桡骨远端方面，已通过手法和石膏治疗，60名患者（61例骨折）在骨折后7天内入组研究，患者使用有源超声设备（30处骨折）或安慰剂器械（31处骨折）每天在家20分钟，持续10周，除了安慰剂器械不发射超声能量外，两种类型的器械完全相同。进行临床检查，并在1、2、3、4、5、6、8、10、12、骨折后16周，超声治疗组骨折愈合时间明显短于安慰剂组（平均值[和标准误差]，61 +/- 3天与98 +/- 5天相比; p < 0.0001），与用安慰剂治疗的组相比，用超声治疗的组中愈合的每个放射学阶段也显著加速，与安慰剂治疗相比，超声波治疗的复位损失明显较小（20 +/-6%对43 +/-8%; p < 0.01），如通过掌侧成角的程度所确定的，以及直到复位丧失停止的平均时间显著减少（12 ± 4天与25 ± 4天相比; P < 0.04）。我们的结论是，这种特定的超声信号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。
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.