The ASPIRE Trial: AchilleS tendinoPathy Treated With cortIcosteRoid injEctions (ASPIRE)
2026年6月16日 更新者：Adam Weir、Erasmus Medical Center
Achilles tendinopathy is a common and often persistent tendon disorder associated with pain, impaired function, and reduced participation in physical activities.
Standard care consists of education, load management advice, and progressive calf-strengthening exercises, yet about half of patients remain symptomatic.
Corticosteroid injections are frequently used in clinical practice, but evidence on long-term efficacy and safety remains inconclusive.
The ASPIRE trial is a multicentre, randomized, double-blind, placebo-controlled phase III trial evaluating whether 1-3 ultrasound-guided peritendinous corticosteroid injections added to standard care are safe and more effective than placebo injections plus standard care in adults with chronic midportion Achilles tendinopathy.
The primary outcomes are change in VISA-A score over 1 year and incidence of full-thickness Achilles tendon rupture during 1-year follow-up.
研究概览
地位
招聘中
条件
详细说明
The ASPIRE trial is designed to address uncertainty regarding peritendinous corticosteroid injections as a second-line treatment for chronic midportion Achilles tendinopathy.
Participants are adults aged 18-65 years with clinically diagnosed and ultrasonographically confirmed chronic midportion Achilles tendinopathy, persistent symptoms for at least 6 months, and ongoing complaints despite standard care including at least 3 months of exercise therapy.
Participants are randomized 1:1 to receive either 1-3 ultrasound-guided peritendinous injections of methylprednisolone acetate 40 mg plus lidocaine, or 1-3 ultrasound-guided placebo injections with lidocaine only.
All participants receive the same standard care consisting of education, load management advice, and a structured progressive calf-muscle strengthening exercise programme supported by an online website.
Follow-up includes clinical assessments, questionnaires, ultrasound imaging, and functional testing at baseline, 3 months, and 1 year, with additional online questionnaires up to 10 years.
研究类型
介入性
注册 (估计的)
276
阶段
- 第三阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Kristel van Abswoude, MD
- 电话号码：+31 6 49326353
- 邮箱：aspire@erasmusmc.nl
学习地点
-
-
-
Rotterdam、荷兰
- 招聘中
- Erasmus MC
-
接触：
- k van Abswoude, MD
- 电话号码：+31 6 49326353
- 邮箱：aspire@erasmusmc.nl
-
接触：
- R.J de Vos, MD/PhD
- 电话号码：+31 10 7040136
- 邮箱：r.devos@erasmusmc.nl
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- Age 18-65 years
- Clinically diagnosed midportion Achilles tendinopathy confirmed by ultrasound
- Symptoms for at least 6 months
- Persistent complaints despite standard care, including education, load management advice and at least 3 months of exercise therapy / exercise programme
Exclusion Criteria:
• Clinical suspicion of insertional Achilles tendinopathy
- Clinical suspicion of Achilles tendon rupture
- Clinical suspicion of plantar flexor tenosynovitis
- Clinical suspicion of sural nerve pathology
- Clinical suspicion of peroneal tendon subluxation or peroneal tendinopathy
- Clinical suspicion of posterior ankle impingement syndrome
- Suspected systemic/inflammatory disorder as cause of symptoms
- Any condition preventing participation in active exercise programme
- History of Achilles tendon rupture of index tendon
- Previous local corticosteroid injection on index Achilles tendon
- Previous surgery on index Achilles tendon
- Refusal to undergo one of the study treatments
- Local skin infection, suspected systemic infection with fever, or other medical condition compromising injection safety
- Vitamin K antagonist use with INR >3.0 within 3 days before injection or unknown INR
- Current pregnancy or breastfeeding
- Medication-induced tendon pathology (quinolones or statins related to symptom onset)
- Inability to provide informed consent
- Participation in another concomitant interventional programme for Achilles tendinopathy
- Known hypersensitivity or allergy to Depo-Medrol or Lidocaine
- Participants with unstable or poorly controlled diabetes mellitus may be excluded at investigator discretion for safety reasons.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Corticosteroid and Lidocaine Injection
Participants receive 1-3 ultrasound-guided peritendinous injections of Depo-Medrol (methylprednisolone acetate 40 mg) combined with lidocaine.
All participants receive one injection at baseline; up to two additional injections may be given within the first 8 weeks at intervals of 4 weeks if predefined criteria are met.
|
Education, load management advice, and a structured progressive calf-muscle strengthening exercise programme supported by an online website.
Participants receive 1-3 ultrasound-guided peritendinous injections of Depo-Medrol (methylprednisolone acetate 40 mg) combined with lidocaine.
其他名称：
|
|
安慰剂比较：Placebo Injection
Participants receive 1-3 ultrasound-guided peritendinous placebo injections consisting of lidocaine only.
All participants receive one injection at baseline; up to two additional injections may be given within the first 8 weeks at intervals of at least 4 weeks if predefined criteria are met.
|
Education, load management advice, and a structured progressive calf-muscle strengthening exercise programme supported by an online website.
Participants receive 1-3 ultrasound-guided peritendinous placebo injections consisting of lidocaine onl
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in disability and symptoms measured with the VISA-A questionnaire.
大体时间：Baseline to 1 year follow-up (timepoints: Baseline, 4 weeks, 8 weeks, 3 months, 6 months, 9 months, and 1-year).
|
Change in disability and symptoms during 1-year follow-up, measured with the validated Victorian Institute of Sport Assessment-Achilles (VISA-A) questionnaire, scored from 0 to 100.
|
Baseline to 1 year follow-up (timepoints: Baseline, 4 weeks, 8 weeks, 3 months, 6 months, 9 months, and 1-year).
|
|
Incidence of full-thickness Achilles tendon rupture
大体时间：During 1-year follow-up
|
Incidence of full-thickness Achilles tendon ruptures during 1-year follow-up, confirmed by medical records or clinical tests and imaging.
|
During 1-year follow-up
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Minor corticosteroid side effects / corticosteroid safety indicators
大体时间：baseline, 3 months, 6 months, 9 months, and 1 year.
|
Body mass (kg)
|
baseline, 3 months, 6 months, 9 months, and 1 year.
|
|
Tendon-related symptoms and disability
大体时间：baseline, 3 months, 6 months, 9 months, and 1 year
|
TENDINopathy Severity Assessment - Achilles (TENDINS-A) score.
0-100; 0= worts, 100= best
|
baseline, 3 months, 6 months, 9 months, and 1 year
|
|
Pain outcomes
大体时间：Assessed at baseline, 3 months, 6 months, 9 months, and 1 year
|
Pain during activity, measured on a VAS 0-10 scale
|
Assessed at baseline, 3 months, 6 months, 9 months, and 1 year
|
|
Global perceived improvement
大体时间：Assessed at 3 months, 6 months, 9 months, and 1 year
|
Global Rating of Change (GROC), 11-point scale
|
Assessed at 3 months, 6 months, 9 months, and 1 year
|
|
Physical function / functional test outcomes
大体时间：Assessed at baseline, 3 months, and 1 year
|
Maximum VAS pain (0-10) during or after palpation of the Achilles tendon
|
Assessed at baseline, 3 months, and 1 year
|
|
Healthcare use
大体时间：Assessed at baseline, 3 months, 6 months, 9 months, and 1 year
|
Medical Consumption Questionnaire (iMCQ) for healthcare use The economic evaluation will be published separately. |
Assessed at baseline, 3 months, 6 months, 9 months, and 1 year
|
|
Imaging outcomes: tendon structure
大体时间：Assessed at baseline, 3 months, and 1 year
|
Ultrasound and ultrasound tissue characterisation of Achilles tendon where the degree of collagen disorganisation is assed using: echo types I, echo types II, echo types III, echo types IV, combined percentage echo types I + II
|
Assessed at baseline, 3 months, and 1 year
|
|
Imaging outcomes: neovascularisation / Doppler flow
大体时间：Assessed at baseline, 3 months, and 1 year
|
percentage of Doppler flow within the color box, quantified with the Surface Area Quantification (SAQ) method
|
Assessed at baseline, 3 months, and 1 year
|
|
Minor corticosteroid side effects / corticosteroid safety indicators
大体时间：baseline, 3 months, and 1 year.
|
Body fat percentage
|
baseline, 3 months, and 1 year.
|
|
Minor corticosteroid side effects / corticosteroid safety indicators
大体时间：baseline, 3 months, and 1 year
|
Waist circumference (cm)
|
baseline, 3 months, and 1 year
|
|
Minor corticosteroid side effects / corticosteroid safety indicators
大体时间：baseline, 3 months, 6 months, 9 months, and 1 year.
|
Hot flushes (5-point scale)
|
baseline, 3 months, 6 months, 9 months, and 1 year.
|
|
Minor corticosteroid side effects / corticosteroid safety indicators
大体时间：baseline, 3 months, 6 months, 9 months, and 1 year
|
Menstrual disturbances (if applicable, 5-point scale)
|
baseline, 3 months, 6 months, 9 months, and 1 year
|
|
Minor corticosteroid side effects / corticosteroid safety indicators
大体时间：baseline, 3 months, 6 months, 9 months, and 1 year.
|
Sleep disturbances (5-point scale)
|
baseline, 3 months, 6 months, 9 months, and 1 year.
|
|
Minor corticosteroid side effects / corticosteroid safety indicators
大体时间：baseline, 3 months, 6 months, 9 months, and 1 year.
|
Appetite (5-point scale)
|
baseline, 3 months, 6 months, 9 months, and 1 year.
|
|
Physical function / functional test outcomes
大体时间：Assessed at baseline, 3 months, and 1 year
|
Maximum VAS pain (0-10) during or after 5 single-leg heel rises
|
Assessed at baseline, 3 months, and 1 year
|
|
Physical function / functional test outcomes
大体时间：Assessed at baseline, 3 months, and 1 year
|
Maximum VAS pain (0-10) during or after 5 hops
|
Assessed at baseline, 3 months, and 1 year
|
|
Physical function / functional test outcomes
大体时间：Assessed at baseline, 3 months, and 1 year
|
Heel Rise Endurance Test (HRET) - repetitions
|
Assessed at baseline, 3 months, and 1 year
|
|
productivity loss
大体时间：Assessed at baseline, 3 months, 6 months, 9 months, and 1 year
|
Institute for Medical Technology Assessment Productivity Cost Questionnaire (iPCQ for productivity loss).
The economic evaluation will be published separately
|
Assessed at baseline, 3 months, 6 months, 9 months, and 1 year
|
|
Imaging outcomes: tendon structure on ultrasound
大体时间：Assessed at baseline, 3 months, and 1 year
|
tendon volume (cubic centimeters)
|
Assessed at baseline, 3 months, and 1 year
|
|
Imaging outcomes: tendon structure on ultrasound
大体时间：Assessed at baseline, 3 months, and 1 year
|
maximum cross-sectional area (square cm)
|
Assessed at baseline, 3 months, and 1 year
|
|
Imaging outcomes: tendon structure on ultrasound
大体时间：Assessed at baseline, 3 months, and 1 year
|
tendon maximum diameter (cm)
|
Assessed at baseline, 3 months, and 1 year
|
|
Pain outcomes
大体时间：Assessed at baseline, 3 months, 6 months, 9 months, and 1 year
|
Pain after activity, measured on a VAS 0-10 scale
|
Assessed at baseline, 3 months, 6 months, 9 months, and 1 year
|
|
Health-related quality of life
大体时间：Assessed at baseline, 3 months, 6 months, 9 months, and 1 year
|
Euro Quality of life 5 Dimensions, 5 Levels questionnaire (EQ-5D-5L).
0-100 score.
0=worst, 100=best
|
Assessed at baseline, 3 months, 6 months, 9 months, and 1 year
|
|
Return to sport / physical activity level
大体时间：Assessed at baseline, 3 months, 6 months, 9 months, and 1 year.
|
Return to desired sports participation using a 7-point scale.
0= worst, 7 full return to sports = best
|
Assessed at baseline, 3 months, 6 months, 9 months, and 1 year.
|
|
Minor corticosteroid side effects
大体时间：baseline, 3 months, and 1 year.
|
Visible skin abnormalities at the injection site scored as present or absent
|
baseline, 3 months, and 1 year.
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
合作者
调查人员
- 首席研究员：Robert Jan de Vos, MD, PhD、Erasmus Medical Centre
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年6月3日
初级完成 (估计的)
2027年12月31日
研究完成 (估计的)
2028年10月31日
研究注册日期
首次提交
2026年6月2日
首先提交符合 QC 标准的
2026年6月10日
首次发布 (实际的)
2026年6月16日
研究记录更新
最后更新发布 (实际的)
2026年6月18日
上次提交的符合 QC 标准的更新
2026年6月16日
最后验证
2026年6月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- MEC-2026-0210
- 2025-524057-13-00 (克蒂斯)
- ZonMw grant number: 1014102241 (其他标识符：ZonMw)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
upon reasonable request.
IPD 共享时间框架
as yet undetermined
IPD 共享访问标准
as yet undetermined
IPD 共享支持信息类型
- 研究方案
- 树液
- 国际碳纤维联合会
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
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