Sydney Sports Medicine Centre, Sydney Olympic Park, NSW 2127, Australia.
BMJ. 2013 Apr 18;346:f2310. doi: 10.1136/bmj.f2310.
To assess the effectiveness of two peritendinous autologous blood injections in addition to a standardised eccentric calf strengthening programme in improving pain and function in patients with mid-portion Achilles tendinopathy.
Single centre, participant and single assessor blinded, parallel group, randomised, controlled trial.
Single sports medicine clinic in New Zealand.
53 adults (mean age 49, 53% men) with symptoms of unilateral mid-portion Achilles tendinopathy for at least three months. Participants were excluded if they had a history of previous Achilles tendon rupture or surgery or had undergone previous adjuvant treatments such as injectable therapies, glyceryl trinitrate patches, or extracorporeal shockwave therapy.
All participants underwent two unguided peritendinous injections one month apart with a standardised protocol. The treatment group had 3 mL of their own whole blood injected while the control group had no substance injected (needling only). Participants in both groups carried out a standardised and monitored 12 week eccentric calf training programme. Follow-up was at one, two, three and six months.
The primary outcome measure was the change in symptoms and function from baseline to six months with the Victorian Institute of Sport Assessment-Achilles (VISA-A) score. Secondary outcomes were the participant's perceived rehabilitation and their ability to return to sport.
26 participants were randomly assigned to the treatment group and 27 to the control group. In total, 50 (94%) completed the six month study, with 25 in each group. Clear and clinically worthwhile improvements in the VISA-A score were evident at six months in both the treatment (change in score 18.7, 95% confidence interval 12.3 to 25.1) and control (19.9, 13.6 to 26.2) groups. The overall effect of treatment was not significant (P=0.689) and the 95% confidence intervals at all points precluded clinically meaningful benefit or harm. There was no significant difference between groups in secondary outcomes or in the levels of compliance with the eccentric calf strengthening programme. No adverse events were reported.
The administration of two unguided peritendinous autologous blood injections one month apart, in addition to a standardised eccentric training programme, provides no additional benefit in the treatment of mid-portion Achilles tendinopathy.
Australian New Zealand Clinical Trials Registry ACTRN12610000824066, WHO U1111-1117-2641.
评估在标准离心小腿强化方案的基础上，两种腱周自体血注射对改善中段跟腱病患者疼痛和功能的效果。
单中心、参与者和单一评估者盲法、平行组、随机对照试验。
新西兰的一家运动医学诊所。
53 名成年人（平均年龄 49 岁，53%为男性），单侧中段跟腱病症状至少持续 3 个月。如果参与者有跟腱断裂或手术史，或接受过注射疗法、硝酸甘油贴剂或体外冲击波治疗等辅助治疗，则将其排除在外。
所有参与者均接受两次相隔一个月的引导腱周注射，采用标准方案。治疗组注射 3 毫升自身全血，而对照组不注射任何物质（仅针刺）。两组参与者均进行 12 周的标准监测离心小腿训练计划。随访时间为 1、2、3 和 6 个月。
主要结局测量指标是 6 个月时 VISA-A 评分（维多利亚州运动评估-跟腱）的症状和功能变化。次要结局指标是参与者对康复的感知和重返运动的能力。
26 名参与者被随机分配到治疗组，27 名参与者被分配到对照组。共有 50 名（94%）参与者完成了 6 个月的研究，治疗组和对照组各有 25 名。治疗组（评分变化 18.7，95%置信区间 12.3 至 25.1）和对照组（19.9，13.6 至 26.2）在 6 个月时 VISA-A 评分均有明显且有临床意义的改善。治疗的总体效果不显著（P=0.689），所有时间点的 95%置信区间均排除了有临床意义的益处或危害。两组在次要结局或对离心小腿强化计划的依从性水平方面无显著差异。没有报告不良事件。
在标准离心训练方案的基础上，每月进行两次非引导腱周自体血注射，对中段跟腱病的治疗没有额外益处。
澳大利亚新西兰临床试验注册 ACTRN12610000824066，世卫组织 U1111-1117-2641。
