Regenerative Medicine Laboratory, BioCruces Health Research Institute, Hospital Universitario Cruces, Pza Cruces s/n, Barakaldo 48903, Spain.
Trials. 2013 Dec 1;14:410. doi: 10.1186/1745-6215-14-410.
Tendinopathy is a difficult problem to manage and can result in significant patient morbidity. Currently, the clinical use of platelet-rich plasma (PRP) in painful tendons is widespread but its efficacy remains controversial.
METHODS/DESIGN: This study is a single-center, randomized double-blind controlled trial. Eighty patients will be allocated to have ultrasound (US)-guided needling combined with a leukocyte-depleted (that is, pure) PRP or lidocaine each alternate week for a total of two interventions. Outcome data will be collected before intervention, and at 6 weeks, 3, 6, and 12 months after intervention.
Changes in pain and activity levels, as assessed by Disabilities of the Arm, Shoulder and Hand (DASH-E, Spanish version) score, at 6 months. We will compare the percentage of patients in each group that achieve a successful treatment defined as a reduction of at least 25% in the DASH-E score. Secondary outcome measures include changes in DASH-E at 3 and 12 months, changes in pain as assessed by the visual analogue scale (VAS) at the 6-week, 3-, 6-, and 12-month follow-up, changes in sonographic features and neovascularity, and percentage of patients in each group with adverse reactions at 3, 6, and 12 months.
The results of this study will provide insights into the effect of pure PRP in tendon and may contribute to identifying the best protocol for PRP application in tendinopathies.
ClinicalTrials.gov: NCT01945528.
肌腱病是一种难以治疗的疾病，会导致患者出现严重的疾病负担。目前，富含血小板的血浆（PRP）在疼痛肌腱中的临床应用较为广泛，但疗效仍存在争议。
方法/设计：这是一项单中心、随机、双盲对照试验。80 名患者将被分配接受超声（US）引导下的针刺联合白细胞去除（即纯）PRP 或利多卡因治疗，每两周交替一次，共进行两次干预。将在干预前、干预后 6 周、3 个月、6 个月和 12 个月收集结局数据。
采用上肢功能障碍（DASH-E，西班牙语版）评分评估 6 个月时疼痛和活动水平的变化。我们将比较每组中达到成功治疗定义（DASH-E 评分至少降低 25%）的患者比例。次要结局测量包括 DASH-E 在 3 个月和 12 个月的变化、视觉模拟评分（VAS）在 6 周、3 个月、6 个月和 12 个月随访时的疼痛变化、超声特征和新生血管的变化，以及每组中在 3 个月、6 个月和 12 个月时出现不良反应的患者比例。
本研究的结果将深入了解纯 PRP 在肌腱中的作用，并有助于确定 PRP 在肌腱病中应用的最佳方案。
ClinicalTrials.gov：NCT01945528。
