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低强度脉冲超声(LIPUS)治疗新鲜锁骨骨折:一项多中心双盲随机对照试验

Low-intensity pulsed ultrasound (LIPUS) in fresh clavicle fractures: a multi-centre double blind randomised controlled trial.

作者信息

Lubbert Pieter H W, van der Rijt Rob H H, Hoorntje Lidewij E, van der Werken Chris

机构信息

Department of Surgery, University Medical Centre Utrecht, Utrecht, The Netherlands.

出版信息

Injury. 2008 Dec;39(12):1444-52. doi: 10.1016/j.injury.2008.04.004. Epub 2008 Jul 25.

Abstract

BACKGROUND

Several randomised trials have been published on the effect of low-intensity pulsed ultrasound (LIPUS) on fracture healing in both distal radius and tibia fractures. Most studies showed a positive effect on time to clinical and radiological healing. We hypothesised that LIPUS has a beneficial effect on the healing of fresh clavicle fractures as well and studied its effect in non-operatively treated shaft fractures.

METHODS

We conducted a randomised double blind, placebo-controlled multi-centre trial in 101 adult patients with a non-operatively treated fresh clavicle shaft fracture. Of these patients, 49 used a placebo transducer and 52 patients had an active transducer with ultrasound stimulation (Exogen 2000). Data were analysed on intention to treat basis. Baseline parameters of both groups were not significantly different.

RESULTS

There were no differences in time to subjective clinical fracture healing, resumption of daily activities, sports or professional work, Visual Analogue pain Scores (VAS) and use of pain medication.

CONCLUSION

Our findings did not confirm that LIPUS accelerates clinical healing time of fresh clavicle shaft fractures.

LEVEL OF EVIDENCE

Level 1 evidence that low-intensity pulsed ultrasound does not accelerate clinical fracture healing in non-operatively treated fresh midshaft clavicle fractures.

摘要

背景

关于低强度脉冲超声(LIPUS)对桡骨远端和胫骨骨折愈合影响的多项随机试验已发表。大多数研究表明,其对临床和影像学愈合时间有积极影响。我们推测LIPUS对新鲜锁骨骨折的愈合也有有益作用,并研究了其在非手术治疗的骨干骨折中的效果。

方法

我们对101例非手术治疗的新鲜锁骨骨干骨折成年患者进行了一项随机双盲、安慰剂对照的多中心试验。其中,49例患者使用安慰剂换能器,52例患者使用带有超声刺激的有源换能器(Exogen 2000)。数据按意向性分析。两组的基线参数无显著差异。

结果

在主观临床骨折愈合时间、恢复日常活动、运动或专业工作、视觉模拟疼痛评分(VAS)以及使用止痛药物方面均无差异。

结论

我们的研究结果未证实LIPUS能加速新鲜锁骨骨干骨折的临床愈合时间。

证据水平

一级证据表明,低强度脉冲超声不能加速非手术治疗的新鲜锁骨中段骨折的临床骨折愈合。

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