Center for Sports Medicine, University Center for Sports, Exercise and Health, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.
BMC Musculoskelet Disord. 2010 Feb 8;11:28. doi: 10.1186/1471-2474-11-28.
Patellar tendinopathy is a major problem for many athletes, especially those involved in jumping activities. Despite its frequency and negative impact on athletic careers, no evidence-based guidelines for management of this overuse injury exist. Since functional outcomes of conservative and surgical treatments remain suboptimal, new diagnostic and therapeutic strategies have to be developed and evaluated. Extracorporeal shockwave therapy (ESWT) appears to be a promising treatment in patients with chronic patellar tendinopathy. ESWT is most often applied after the known conservative treatments have failed. However, its effectiveness as primary therapy has not been studied in athletes who keep playing sports despite having patellar tendon pain. The aim of this study is to determine the effectiveness of ESWT in athletes with patellar tendinopathy who are still in training and competition.
METHODS/DESIGN: The TOPGAME-study (Tendinopathy of Patella Groningen Amsterdam Maastricht ESWT) is a multicentre two-armed randomised controlled trial with blinded participants and outcome assessors, in which the effectiveness of patient-guided focussed ESWT treatment (compared to placebo ESWT) on pain reduction and recovery of function in athletes with patellar tendinopathy will be investigated. Participants are volleyball, handball and basketball players with symptoms of patellar tendinopathy for a minimum of 3 to a maximum duration of 12 months who are still able to train and compete. The intervention group receives three patient-guided focussed medium-energy density ESWT treatments without local anaesthesia at a weekly interval in the first half of the competition. The control group receives placebo treatment. The follow-up measurements take place 1, 12 and 22 weeks after the final ESWT or placebo treatment, when athletes are still in competition. Primary outcome measure is the VISA-P (Victorian Institute of Sport Assessment - patella) score. Data with regard to pain during function tests (jump tests and single-leg decline squat) and ultrasound characteristics are also collected. During the follow-up period participants also register pain, symptoms, sports participation, side effects of treatment and additional medical consumption in an internet-based diary.
The TOPGAME-study is the first RCT to study the effectiveness of patient-guided ESWT in athletes with patellar tendinopathy who are still in training and competition.
Trial registration number NTR1408.
髌腱病是许多运动员的一个主要问题，尤其是那些参与跳跃活动的运动员。尽管这种过度使用损伤很常见，且对运动员的职业生涯有负面影响，但目前尚无针对这种疾病的循证管理指南。由于保守治疗和手术治疗的功能结果仍然不尽如人意，因此必须开发和评估新的诊断和治疗策略。体外冲击波疗法（ESWT）似乎是治疗慢性髌腱病的一种有前途的治疗方法。ESWT 通常在已知的保守治疗失败后应用。然而，在髌腱疼痛仍在继续的运动员中，作为主要治疗方法，其有效性尚未得到研究。本研究旨在确定 ESWT 在仍在训练和比赛的髌腱病运动员中的疗效。
方法/设计：TOPGAME 研究（格罗宁根-阿姆斯特丹-马斯特里赫特髌腱 ESWT）是一项多中心、双臂、随机对照试验，参与者和结果评估者均为盲法，旨在研究患者指导下聚焦 ESWT 治疗（与安慰剂 ESWT 相比）对髌腱病运动员疼痛减轻和功能恢复的疗效。参与者为排球、手球和篮球运动员，患有髌腱病症状至少 3 个月，最长 12 个月，且仍能训练和比赛。干预组在比赛的前半段，每周接受 3 次患者指导下聚焦的中等能量密度 ESWT 治疗，无需局部麻醉。对照组接受安慰剂治疗。在最后一次 ESWT 或安慰剂治疗后 1、12 和 22 周进行随访测量，此时运动员仍在比赛中。主要结局指标是 VISA-P（维多利亚运动评估-髌腱）评分。还收集了与功能测试（跳跃测试和单腿下蹲）期间疼痛以及超声特征有关的数据。在随访期间，参与者还在一个基于互联网的日记中记录疼痛、症状、运动参与、治疗副作用和额外的医疗消费。
TOPGAME 研究是第一项研究患者指导 ESWT 在仍在训练和比赛的髌腱病运动员中的有效性的 RCT。
试验注册号 NTR1408。
