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体外冲击波治疗肩袖慢性非钙化性肌腱病的短期疗效:一项双盲、随机、安慰剂对照试验。

Short-term outcomes of extracorporeal shock wave therapy for the treatment of chronic non-calcific tendinopathy of the supraspinatus: a double-blind, randomized, placebo-controlled trial.

机构信息

Department of Orthopaedic and Trauma Surgery, Magna Græcia University, V.le Europa88100, Catanzaro, Italy.

出版信息

BMC Musculoskelet Disord. 2012 Jun 6;13:86. doi: 10.1186/1471-2474-13-86.

DOI:10.1186/1471-2474-13-86
PMID:22672772
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3434084/
Abstract

BACKGROUND

There is evidence supporting the use of extracorporeal shock wave therapy (ESWT) in calcific tendinopathy of the rotator cuff, but the best current evidence does not support its use in non-calcifying tendinopathy. We conducted a randomized placebo-controlled trial to investigate the efficacy and safety of low energy ESWT for non-calcifying tendinopathy of the rotator cuff.

METHODS

20 patients with non-calcifying supraspinatus tendinopathy (NCST) were randomized to an active or a sham treatment group. Physical, blood, roentgenographic, and MRI examinations of the shoulder were conducted to verify that patients met the inclusion and exclusion criteria. These examinations were repeated six and twelve weeks after treatments. Effectiveness was determined by comparison of the mean improvement in the Constant and Murley score (CMS) between the treatment and the placebo groups at three months. Safety was assessed by analyzing the number and severity of adverse events.

RESULTS

All the patients completed the investigation protocol. At the final follow-up, significant improvement in the total CMS score and most of the CMS subscales was observed in the ESWT group when compared to the baseline values. Significantly higher total CMS, and significantly higher scores for CMS pain and ROM were observed in the ESWT group when compared to the placebo. No serious adverse events were noted after ESWT.

CONCLUSIONS

Patients suffering from NCST may benefit from low energy ESWT, at least in short-term. The application protocol of ESWT is likely to play a key-role in a successful treatment. Future investigations should be undertaken on the long-term effects of this technique for the treatment of NCST.

TRIAL REGISTRATION

Current Controlled Trials ISRCTN41236511.

摘要

背景

有证据支持体外冲击波疗法(ESWT)在肩袖钙化性肌腱炎中的应用,但目前最佳证据并不支持其在非钙化性肌腱病中的应用。我们进行了一项随机安慰剂对照试验,以研究低能量 ESWT 治疗肩袖非钙化性肌腱病的疗效和安全性。

方法

20 例非钙化性冈上肌腱炎(NCST)患者被随机分为活性治疗组或假治疗组。对肩部进行物理、血液、射线照相和 MRI 检查,以验证患者符合纳入和排除标准。这些检查在治疗后 6 周和 12 周重复进行。通过比较治疗组和安慰剂组在 3 个月时 Constant 和 Murley 评分(CMS)的平均改善程度来确定疗效。通过分析不良事件的数量和严重程度来评估安全性。

结果

所有患者均完成了研究方案。在最终随访时,与基线值相比,ESWT 组的总 CMS 评分和大多数 CMS 子量表均显著改善。与安慰剂相比,ESWT 组的总 CMS 评分以及 CMS 疼痛和 ROM 评分均显著更高。ESWT 后未出现严重不良事件。

结论

患有 NCST 的患者可能会从低能量 ESWT 中受益,至少在短期内如此。ESWT 的应用方案可能在成功治疗中发挥关键作用。未来的研究应该针对该技术治疗 NCST 的长期效果进行。

试验注册

当前对照试验 ISRCTN41236511。

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