Pettrone Frank A, McCall Brian R
Commonwealth Orthopaedics, 1635 North George Mason Drive, Suite 310, Arlington, VA 22205, USA.
J Bone Joint Surg Am. 2005 Jun;87(6):1297-304. doi: 10.2106/JBJS.C.01356.
The use of extracorporeal shock wave therapy for the treatment of lateral epicondylitis is controversial. The purpose of this study was to evaluate the use of extracorporeal shock wave therapy without local anesthesia to treat chronic lateral epicondylitis.
One hundred and fourteen patients with a minimum six-month history of lateral epicondylitis that was unresponsive to conventional therapy were randomized into double-blind active treatment and placebo groups. The protocol consisted of three weekly treatments of either low-dose shock wave therapy without anesthetic or a sham treatment. Patients had a physical examination, including provocation testing and dynamometry, at one, four, eight, and twelve weeks and at six and twelve months after treatment. Radiographs, laboratory studies, and electrocardiograms were also evaluated prior to participation and at twelve weeks. A visual analog scale was used to evaluate pain, and an upper extremity functional scale was used to assess function. Crossover to active treatment was initiated for nonresponsive patients who had received the placebo and met the inclusion criteria after twelve weeks.
A total of 108 of the 114 randomized patients completed all treatments and the twelve weeks of follow-up required by the protocol. Sixty-one patients completed one year of follow-up, whereas thirty-four patients crossed over to receive active treatment. A significant difference (p = 0.001) in pain reduction was observed at twelve weeks in the intent-to-treat cohort, with an improvement in the pain score of at least 50% seen in 61% (thirty-four) of the fifty-six patients in the active treatment group who were treated according to protocol compared with 29% (seventeen) of the fifty-eight subjects in the placebo group. This improvement persisted in those followed to one year. Functional activity scores, activity-specific evaluation, and the overall impression of the disease state all showed significant improvement as well (p < 0.05). Crossover patients also showed significant improvement after twelve weeks of active treatment, with 56% (nineteen of thirty-four) achieving an improvement in the pain score of at least 50% (p < 0.0001).
These results demonstrate that low-dose shock wave therapy without anesthetic is a safe and effective treatment for chronic lateral epicondylitis.
体外冲击波疗法用于治疗外侧上髁炎存在争议。本研究的目的是评估在不进行局部麻醉的情况下使用体外冲击波疗法治疗慢性外侧上髁炎的效果。
114例患有至少6个月外侧上髁炎病史且对传统治疗无反应的患者被随机分为双盲主动治疗组和安慰剂组。方案包括每周进行3次治疗，治疗方式为无麻醉的低剂量冲击波疗法或假治疗。患者在治疗后1周、4周、8周、12周以及6个月和12个月时接受体格检查，包括激发试验和握力测试。在参与研究前和12周时还对X光片、实验室检查和心电图进行评估。使用视觉模拟量表评估疼痛情况，使用上肢功能量表评估功能。对于接受安慰剂治疗且在12周后符合纳入标准的无反应患者，开始交叉接受主动治疗。
114例随机分组的患者中，共有108例完成了所有治疗以及方案要求的12周随访。61例患者完成了1年的随访，而34例患者交叉接受了主动治疗。在意向性治疗队列中，12周时观察到疼痛减轻存在显著差异（p = 0.001），按照方案接受治疗的主动治疗组56例患者中有61%（34例）疼痛评分改善至少50%，而安慰剂组58例受试者中这一比例为29%（17例）。这种改善在随访至1年的患者中持续存在。功能活动评分、特定活动评估以及疾病状态的总体印象也均显示出显著改善（p < 0.05）。交叉患者在接受12周主动治疗后也显示出显著改善，56%（34例中的19例）疼痛评分改善至少50%（p < 0.0001）。
这些结果表明，无麻醉的低剂量冲击波疗法是治疗慢性外侧上髁炎的一种安全有效的方法。
