Gerdesmeyer Ludger, Frey Carol, Vester Johannes, Maier Markus, Weil Lowell, Weil Lowell, Russlies Martin, Stienstra John, Scurran Barry, Fedder Keith, Diehl Peter, Lohrer Heinz, Henne Mark, Gollwitzer Hans
Department of Orthopedic and Traumatology, Technical University Munich, Klinikum Rechts der Isar, Germany.
Am J Sports Med. 2008 Nov;36(11):2100-9. doi: 10.1177/0363546508324176. Epub 2008 Oct 1.
Radial extracorporeal shock wave therapy is an effective treatment for chronic plantar fasciitis that can be administered to outpatients without anesthesia but has not yet been evaluated in controlled trials.
There is no difference in effectiveness between radial extracorporeal shock wave therapy and placebo in the treatment of chronic plantar fasciitis.
Randomized, controlled trial; Level of evidence, 1.
Three interventions of radial extracorporeal shock wave therapy (0.16 mJ/mm(2); 2000 impulses) compared with placebo were studied in 245 patients with chronic plantar fasciitis. Primary endpoints were changes in visual analog scale composite score from baseline to 12 weeks' follow-up, overall success rates, and success rates of the single visual analog scale scores (heel pain at first steps in the morning, during daily activities, during standardized pressure force). Secondary endpoints were single changes in visual analog scale scores, success rates, Roles and Maudsley score, SF-36, and patients' and investigators' global judgment of effectiveness 12 weeks and 12 months after extracorporeal shock wave therapy.
Radial extracorporeal shock wave therapy proved significantly superior to placebo with a reduction of the visual analog scale composite score of 72.1% compared with 44.7% (P = .0220), and an overall success rate of 61.0% compared with 42.2% in the placebo group (P = .0020) at 12 weeks. Superiority was even more pronounced at 12 months, and all secondary outcome measures supported radial extracorporeal shock wave therapy to be significantly superior to placebo (P < .025, 1-sided). No relevant side effects were observed.
Radial extracorporeal shock wave therapy significantly improves pain, function, and quality of life compared with placebo in patients with recalcitrant plantar fasciitis.
放射状体外冲击波疗法是治疗慢性足底筋膜炎的一种有效方法，无需麻醉即可在门诊进行，但尚未在对照试验中得到评估。
放射状体外冲击波疗法与安慰剂在治疗慢性足底筋膜炎方面的疗效没有差异。
随机对照试验；证据等级，1级。
在245例慢性足底筋膜炎患者中，研究了三种放射状体外冲击波疗法干预措施（0.16 mJ/mm(2)；2000次脉冲）与安慰剂的对比。主要终点是从基线到12周随访时视觉模拟量表综合评分的变化、总体成功率以及单个视觉模拟量表评分（早晨第一步时的足跟疼痛、日常活动期间、标准化压力时）的成功率。次要终点是体外冲击波治疗后12周和12个月时视觉模拟量表评分的单个变化、成功率、罗尔斯和莫兹利评分、SF-36以及患者和研究者对疗效的整体判断。
放射状体外冲击波疗法被证明明显优于安慰剂，12周时视觉模拟量表综合评分降低了72.1%，而安慰剂组为44.7%（P = 0.0220），总体成功率为61.0%，安慰剂组为42.2%（P = 0.0020）。在12个月时优势更加明显，所有次要结局指标均支持放射状体外冲击波疗法明显优于安慰剂（P < 0.025，单侧）。未观察到相关副作用。
与安慰剂相比，放射状体外冲击波疗法能显著改善顽固性足底筋膜炎患者的疼痛、功能和生活质量。
