Physical Medicine and Rehabilitation Unit, Azienda Policlinico Umberto I, School of Medicine, "La Sapienza" University of Rome, Rome, Italy.
Phys Ther. 2012 Nov;92(11):1376-85. doi: 10.2522/ptj.20110252. Epub 2012 Jun 28.
Extracorporeal shock-wave therapy (ESWT) represents a valid intervention in the treatment of people with supraspinatus calcifying tendinitis (SCT), but there is limited evidence for the useful range of ESWT doses.
The aim of this study was to compare 2 different ranges of energy flux density in treatment of SCT with ESWT.
This study was designed as a single-blind randomized clinical trial.
This study was performed in a university hospital.
Forty-six patients with SCT were randomly assigned to 2 groups that received different therapeutic energy doses of ESWT: (1) group A received ESWT at an energy level of 0.20 mJ/mm², and (2) group B received ESWT at an energy level of 0.10 mJ/mm².
The treatment protocol consisted of 4 sessions performed once a week.
The change in mean Constant Murley Scale (CMS) scores at 3 and 6 months was the primary endpoint. The change in the mean visual analog scale (VAS) scores from baseline to 3 and 6 months after the intervention and radiographic change in size of calcium deposits were evaluated as secondary endpoints. At 12 months, pain relief was assessed using a numeric rating scale.
Significant clinical improvement based on mean CMS scores was observed after 6 months in group A (X=79.43, SD=10.33) compared with group B (X=57.91, SD=6.53). Likewise, after 6 months, a significant decrease in VAS scores was found in group A (X=2.09, SD=1.54) compared with group B (X=5.36, SD=0.78). Calcific deposits disappeared in the same percentage of patients in both groups.
The small sample size and lack of a control group were limitations of the study.
In ESWT for SCT, an energy level of 0.20 mJ/mm² appears to be more effective than an energy level of 0.10 mJ/mm² in pain relief and functional improvement.
体外冲击波疗法（ESWT）是治疗肩袖钙化性肌腱炎（SCT）的有效方法，但 ESWT 剂量的有效范围证据有限。
本研究旨在比较 ESWT 治疗 SCT 的两种不同能量通量密度范围。
本研究设计为单盲随机临床试验。
本研究在一所大学医院进行。
46 例 SCT 患者随机分为两组，分别接受不同的 ESWT 治疗能量剂量：（1）组 A 接受 0.20 mJ/mm² 的 ESWT，（2）组 B 接受 0.10 mJ/mm² 的 ESWT。
治疗方案包括每周一次的 4 次治疗。
3 个月和 6 个月时平均 Constant Murley 量表（CMS）评分的变化是主要终点。干预后 3 个月和 6 个月时平均视觉模拟量表（VAS）评分的变化以及钙沉积大小的影像学变化作为次要终点进行评估。在 12 个月时，使用数字评分量表评估疼痛缓解情况。
与组 B（X=57.91，SD=6.53）相比，组 A（X=79.43，SD=10.33）在 6 个月时基于 CMS 评分的平均评分显示出显著的临床改善。同样，在 6 个月时，组 A 的 VAS 评分也显著下降（X=2.09，SD=1.54），而组 B 的 VAS 评分（X=5.36，SD=0.78）则有所下降。两组患者的钙化沉积物消失率相同。
本研究的局限性是样本量小且缺乏对照组。
在 SCT 的 ESWT 中，0.20 mJ/mm² 的能量水平似乎比 0.10 mJ/mm² 的能量水平在缓解疼痛和改善功能方面更有效。
