KinEf Kinesiología Deportiva, Buenos Aires, Argentina.
IMAXE Diagnostico X Imagenes, Buenos Aires, Argentina.
J Orthop Surg Res. 2019 Jul 23;14(1):234. doi: 10.1186/s13018-019-1283-x.
Acute injuries of the hamstring muscle complex (HMC) type 3b (interfascicle/bundle-tear) are frequently observed in various sports disciplines both in elite and recreational sport. The treatment of choice of acute HMC injuries type 3b is a progressive physiotherapeutic exercise programme. Besides this, there is currently only insufficient scientific evidence to support other treatment methods, including local infiltrations and injections of platelet-rich-plasma. Very recently, it was demonstrated that extracorporeal shock wave therapy (ESWT) may accelerate regeneration after acute skeletal muscle injury. The aim of the present study is to test the hypothesis that the combination of radial ESWT (rESWT) and a specific rehabilitation program (RP) is effective and safe in treatment of acute HMC injury type 3b in athletes, and is statistically significantly more effective than the combination of sham-rESWT and RP.
We will perform a double blind, randomized, sham-controlled clinical trial at the clinic KinEf Kinesiología Deportiva, Ciudad Autónoma de Buenos Aires, Argentina. Forty patients with acute HMC injury type 3b will be randomly allocated to receive either rESWT (nine rESWT sessions; three sessions per week; 2500 radial extracorporeal shock waves (rESWs) per session; energy density depending on what the patient tolerates) or sham-rESWT. In addition, all patients will receive a specific rehabilitation program that will last for 8 weeks. The primary outcome measure will be the individual time (days) necessary to return to play. Secondary outcomes will include the presence or absence of reinjury during a time period of 6 months after inclusion into the study.
Because of the lack of adequate treatment options for acute HMC injury type 3b in athletes and particularly the high reinjury rate, we hypothesize that the results of this trial will be of importance and have impact on clinical practice.
ClinicalTrials.gov ID NCT03473899 . Registered March 22, 2018.
在各种运动项目中，包括精英运动和业余运动，都经常观察到 3b 型（束间/束撕裂）腘绳肌复合体（HMC）急性损伤。3b 型急性 HMC 损伤的首选治疗方法是渐进式物理治疗运动方案。除此之外，目前只有有限的科学证据支持其他治疗方法，包括局部浸润和富含血小板的血浆注射。最近，研究表明体外冲击波治疗（ESWT）可能加速急性骨骼肌损伤后的再生。本研究的目的是检验假设，即径向 ESWT（rESWT）与特定康复方案（RP）的联合治疗对运动员 3b 型急性 HMC 损伤是有效且安全的，并且在统计学上明显优于 sham-rESWT 与 RP 的联合治疗。
我们将在阿根廷布宜诺斯艾利斯市的 KinEf Kinesiología Deportiva 诊所进行一项双盲、随机、 sham 对照临床试验。将 40 名 3b 型急性 HMC 损伤患者随机分为 rESWT 组（9 次 rESWT 治疗；每周 3 次；每次治疗 2500 次径向体外冲击波；能量密度取决于患者的耐受程度）或 sham-rESWT 组。此外，所有患者都将接受为期 8 周的特定康复方案。主要观察指标是恢复运动所需的个体时间（天）。次要观察指标包括纳入研究后 6 个月内是否有再损伤。
由于运动员 3b 型急性 HMC 损伤的治疗选择有限，特别是再损伤率高，我们假设该试验的结果将对临床实践具有重要意义和影响。
ClinicalTrials.gov 编号 NCT03473899。注册于 2018 年 3 月 22 日。
